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ENCELTO revakinagene taroretcel-lwey 440000 [arb'U]/1 Implant, 1 capsule — NDC 82958-0501-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

ENCELTO revakinagene taroretcel-lwey 440000 [arb'U]/1 Implant, 1 capsule — NDC 82958-501-01 (Billing 82958-0501-01)

by Neurotech Pharmaceuticals, Inc. · 1 CAPSULE in 1 CONTAINER / 1 IMPLANT in 1 CAPSULE

This is a package of 1 capsule of ENCELTO revakinagene taroretcel-lwey 440000 [arb'U]/1 Implant from Neurotech Pharmaceuticals, Inc., marketed since Mar 2025 and currently FDA-listed. It is this product's only package size.

NDC 82958-0501-01
🏷️ FDA NDC (as labeled) 82958-501-01 billing pads the product segment with a zero
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Sep 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 82958-501-01 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
82958 labeler · 501 product · 01 package
Package marketed since
Mar 12, 2025
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Billing quantity
1 EA per package
Barcode (UPC-A, from the NDC)
3 8295850101 4
FDA record last changed
Sep 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 82958-501-01
Product NDC 82958-501
11-digit billing NDC 82958050101
NCPDP billing unit EA — each (per item)
RxCUI 2708837, 2708843
UNII Q7V7NYG6GM
Application # BLA125798
SPL Set ID 1ae9482a-b478-4e21-9166-b5fd52d3ef9c
DEA schedule Non-controlled
Marketing category BLA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-03-12
Route INTRAVITREAL
Dosage form IMPLANT
Substance REVAKINAGENE TARORETCEL-LWEY
Biologic (Purple Book) 351(a)

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GCN Seq No 087457
GCN 57372
HICL code 050375
Ingredient (HICL) Revakinagene Taroretcel-Lwey
HIC1 code Q
Therapeutic class — broad (HIC1) Ear/Eye/Nose/Rectum/Topical/Vagina/Other
HIC2 code Q2
Therapeutic class — intermediate (HIC2) Drugs Acting On The Eye
HIC3 code Q2V
Therapeutic class — specific (HIC3) Ophthalmic Cell/Gene Therapy Agents
AHFS code 26:12.00.00
AHFS class Gene Therapy
FDB label name ENCELTO IMPLANT
FDB brand name Encelto
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 087457
  • GCN: 57372
  • HICL (First Databank): 050375
  • AHFS class code: 26:12.00.00
  • RxCUI (RxNorm): 2708837
Why two NDCs? The FDA registers this code as 82958-501-01 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 82958-0501-01. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

Clinical

Label name ENCELTO IMPLANT Ingredient Revakinagene Taroretcel-Lwey
📖 What it is MedlinePlus · NLM

Revakinagene taroretcel-lwey is used to treat idiopathic macular telangiectasia type 2 (MacTel) (an eye disease of the retina). Revakinagene taroretcel-lwey is in a class of medications called gene therapy. It works by providing a protein that helps to protect light-sensing cells (photoreceptors) in the retina.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Encelto treats adults with idiopathic macular telangiectasia type 2, or MacTel. It is a small implant placed inside the eye that releases a protein thought to help protect light-se...
  • It is placed in the eye during a single surgery by an ophthalmologist. You get one implant for each affected eye. Afterward you use antibiotic and steroid eye drops as directed.
  • Eye-related effects are common. These include bleeding on the eye surface, slow adjustment to dim light, eye pain, a gritty feeling, and suture irritation. Mention anything bothers...
  • Call right away for worsening eye pain, vision loss, a red eye, sudden flashing lights, or new floaters. These can mean infection or a retinal problem. Quick treatment matters.
📖 Read our full Revakinagene Taroretcel-Lwey guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
82958-0501-01 You're viewing this Main listing 1 CAPSULE in 1 CONTAINER / 1 IMPLANT in 1 CAPSULE 2025-03-12 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Encelto 440000 [arb'U]this 82958-0501-01 Neurotech 1 capsule — — FDA listed —
About this product: this is a biologic. Biologics don't have small-molecule generics — competition comes from FDA-licensed biosimilars (shown above), not generics.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & biosimilar status

🏛️
2025
First FDA approval
Mar 2025
📍
2026
Currently FDA-listed
1 year listed
🛡️
2037
Latest patent/protection listed
not a guaranteed launch date
🧬Biologic — competition comes from biosimilars

Biologics have no small-molecule generics; biosimilar competition is tracked in the FDA Purple Book.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Mar 2037. This may affect when biosimilars become widely available, but it is not a guaranteed launch date.
📅 FDA approved Mar 5, 2025 ⏳ ~10.4 yr to latest listed protection

Why the date isn’t exact: Biosimilar timing can change because patents may be challenged, settled, licensed, added or removed, and litigation can move the real date earlier or later.

FDA Purple Book — biosimilars & interchangeables ⓘ
Reference product
enceltorevakinagene taroretcel-lwey
🔒 No FDA-licensed biosimilars or interchangeable biosimilars are listed yet for this biologic. It currently has no biosimilar competition in the FDA Purple Book.
Source: FDA Purple Book (purplebooksearch.fda.gov), matched on the reference product’s active ingredient.
Patents & exclusivity — FDA Purple Book
Exclusivity RefProduct
2025 2027 2029 2031 2033 2035 2037
Today
LOE
Biologic patent Exclusivity
🏛️Reference-product exclusivity
A flat 12 years of FDA market protection from first licensure. No biosimilar can be licensed before it ends — regardless of patents.
🧪Listed biologic patents
Patents the reference maker lists covering the molecule, formulation, or manufacturing. A biosimilar generally can’t launch until these resolve.
🔁Interchangeability
An interchangeable biosimilar may be substituted at the pharmacy (state laws vary). The first one can earn its own exclusivity period.
🛈 What do these terms mean?
Biologic patent
A patent the reference product’s maker has publicly listed. A biosimilar generally can’t launch until these expire — unless they’re invalidated or resolved in a settlement.
Reference-product exclusivity
A flat 12 years of FDA market protection from the biologic’s first licensure (the BPCIA). No biosimilar can be licensed before it ends, regardless of patents.
Interchangeable exclusivity
The first interchangeable biosimilar can earn a period as the only interchangeable version (pharmacists can substitute it without the prescriber).
Earliest biosimilar (LOE)
The latest of all the dates above — the soonest a biosimilar can realistically reach the market. Litigation and settlements can move it earlier.

Biologics have no small-molecule “generics” — competition comes from FDA-licensed biosimilars, tracked in the FDA Purple Book.

FDA exclusivity
CodeWhat it grantsExpires
RefProductReference-product exclusivity (12-year, BPCIA) — no biosimilar can be licensed before this dateMar 5, 2037
Common questions
Is there a biosimilar for ENCELTO IMPLANT?
No FDA-licensed biosimilar is currently listed for this biologic in the FDA Purple Book.
Why do different websites show different biosimilar dates?
Biosimilar availability isn’t based on one single date. Some sources use the reference-product exclusivity, some use the last listed patent, and patent litigation, settlements, and licenses can all change the real-world launch date. This page shows the underlying Purple Book dates so you can see why estimates differ.
Can a biosimilar launch before the last patent expires?
Sometimes. A biosimilar maker may settle with the reference manufacturer or receive a license to launch earlier. In other cases, the last listed protection delays competition.
What does “current Purple Book estimate” mean?
It means we’re using the latest patent and exclusivity dates currently listed in the FDA Purple Book. It is not a guaranteed launch date.
What does “FDA listed” mean?
It means the product appears in the FDA’s official directory. That’s a good sign a product exists for the U.S. market, but on its own it does not confirm a pharmacy can get it today. Where we have recent retail pricing data, we label it “Availability likely” instead.
What does a patent or protection date mean here?
It’s the latest date currently listed in the FDA Purple Book for a patent or exclusivity on the reference biologic. It can affect when a biosimilar becomes widely available — but it is not a guaranteed launch date. Settlements and licenses can move the real date earlier or later.
Built from the FDA Purple Book Patent List (patents the reference-product sponsor has publicly listed under the BPCIA) plus reference-product exclusivity. Biosimilars cannot launch until these clear; patent litigation and settlements can shift the real date. Biologics have no small-molecule generics — competition comes from FDA-licensed biosimilars, not the Orange Book.
Where does this data come from?
Patents and exclusivity from the FDA Purple Book (biologics), refreshed from public FDA data. Biosimilar launch timing is an estimate, not a guarantee.

What it looks like

Color white
Shapecapsule
Size7 mm
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

A current SPL was checked, but it does not contain a structured or narrative inactive-ingredient list for this product. This does not mean the product has no inactive ingredients.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerNeurotech Pharmaceuticals, Inc.
FDA applicationBLA125798 (BLA)
Labeler code82958
First marketedMar 2025
Product typeHuman Prescription Drug
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 👥 Use in Specific Populations 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Patient Package Insert 📖 Instructions for Use 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 40 words ▾

1 INDICATIONS AND USAGE ENCELTO is indicated for the treatment of adults with idiopathic macular telangiectasia type 2 (MacTel). ENCELTO is an allogeneic encapsulated cell-based gene therapy indicated for the treatment of adults with idiopathic macular telangiectasia type 2 (MacTel).

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION For intravitreal implantation only. ENCELTO is intended for surgical intravitreal implantation under aseptic conditions by a qualified ophthalmologist. ( 2.1 ) The recommended dose is one ENCELTO implant per affected eye containing 200,000 to 440,000 allogeneic retinal pigment epithelial cells expressing recombinant human ciliary neurotrophic factor (rhCNTF).

( 2.1 ) Carefully inspect ENCELTO prior to use and refer to the Instructions for Use when preparing for and performing surgical placement or removal of ENCELTO. ( 2.2 , 2.3 )

2.1Recommended Dose For intravitreal implantation only • ENCELTO is administered by a single surgical intravitreal procedure performed by a qualified ophthalmologist. • The recommended dose is one ENCELTO implant per affected eye. Each ENCELTO implant contains 200,000 to 440,000 allogeneic retinal pigment epithelial cells expressing recombinant human ciliary neurotrophic factor (rhCNTF) (NTC-201-6A cell line), a neurotrophic factor.

2.2ENCELTO Surgical Placement The ENCELTO implant insertion is a surgical procedure performed in an operating room under aseptic conditions by a qualified ophthalmologist. Pre-Surgical Preparation Inspect the ENCELTO packaging for any signs of damage or leakage. Verify the use-by date.

Confirm that the disposable temperature recording device displays a checkmark at the top of the screen. Ensure the liquid medium is at the correct pH using the provided pH color guide reference card. Prepare the surgical field properly.

Surgical Steps 1. Preparing the Surgical Site a. Create a 7x7 mm peritomy of the conjunctiva and Tenon’s capsule at the selected implantation site. b.

Place a corneal-limbal traction suture in the selected surgical quadrant (either inferotemporal or inferonasal) ( Figure 1 ). c. Maintain hemostasis of the underlying sclera and conjunctiva ( Figure 1 ). d. Using an MVR and 15-degree blade, create a 3.0 mm full-thickness sclerotomy 3.75 mm posterior and parallel to the limbus ( Figure 2 ).

Do not insert ENCELTO outside of the pars plana. e. Confirm: • The incision is full thickness. • There is adequate hemostasis. • There is no spanning uveal tissue. 2.

Preparing the ENCELTO Implant a. Open the inner container and expose the upper compartment and luer lock cap ( Figure 3 ). b. Unlock the luer lock cap by turning it counterclockwise once. c.

Lift the luer lock cap vertically to remove ENCELTO (attached to the gripper). d. Rinse ENCELTO with at least 5 mL of sterile Balanced Saline Solution (BSS). e. Keep ENCELTO moist by applying BSS every 10 minutes until insertion. f.

While holding the luer lock cap, pass a double-armed 9-0 polypropylene suture needle through ENCELTO’s fixation loop ( Figure 4 ). 3. Implantation of ENCELTO a.

Gently open the sclerotomy incision and insert ENCELTO perpendicularly into the eye ( Figure 5 ). b. Ensure only the fixation loop is exposed. c. Release ENCELTO from the gripper by squeezing the indicated region with forceps or a fine needle holder ( Figure 6 ).

4. Securing the Implant a. Secure ENCELTO by creating a 3-1-1 anchor knot with the polypropylene suture at the apex of the fixation loop ( Figure 7 ). b.

Confirm ENCELTO is centered in the incision. c. Pass each suture arm centrally through either side of the wound at 90-99% scleral depth ( Figure 8 ). d. Pull up the suture ends and confirm that the fixation loop is at the proper depth (90-99%). e.

Tie down the suture to the sclera with a 3-1-1 knot, ensuring the knot is placed away from the incision. f. If a suture breaks, leave the tail as long as possible and lay it flat. g. Take a 2.0 mm scleral bite at 50-75% depth beyond the sclerotomy on each side ( Figure 9 ).

5. Closing the Incision a. Close the scleral incision with 9-0 nylon sutures ( Figure 10 ), ensuring: The polypropylene suture is captured to prevent irritation and erosion.

All nylon suture knots are rotated into the sclera. The closure is watertight. b. Pull the polypropylene suture… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 99 words ▾

3 DOSAGE FORMS AND STRENGTHS ENCELTO is a single-dose implant that contains 200,000 to 440,000 allogeneic retinal pigment epithelial cells expressing recombinant human ciliary neurotrophic factor (rhCNTF) (NTC-201-6A cell line) for intravitreal surgical placement. ENCELTO is an opaque semi-permeable capsule that is white to off-white, capped on both ends, and has a titanium loop on one end. The ENCELTO width is 1.2 ± 0.1 mm, its length is 6.1 ± 0.4 mm, and its internal diameter is 0.88 ± 0.02 mm ( Figure 17 ).

One single-dose implant containing 200,000 to 440,000 allogeneic retinal pigment epithelial cells expressing rhCNTF.

⛔ Contraindications 41 words ▾

4 CONTRAINDICATIONS ENCELTO is contraindicated in patients with: Active or suspected ocular or periocular infections. Known hypersensitivity to Endothelial Serum Free Media (Endo-SFM) Ocular or periocular infections. ( 4 ) Known hypersensitivity to Endothelial Serum Free Media (Endo-SFM). ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS ENCELTO implantation has been associated with severe vision loss, infectious endophthalmitis, retinal tears and/or detachment, vitreous hemorrhage, implant extrusion, cataract formation, suture related complications, and delayed dark adaptation. Patients should be instructed to report signs or symptoms that could be associated with these events without delay. Additional surgical and/or medical management may be required.

( 5.1 , 5.2 , 5.3 , 5.4 , 5.5 , 5.6 , 5.7 , 5.8 ) Vitreous Hemorrhage: Temporarily discontinue antithrombotic medication prior to ENCELTO insertion surgery to reduce the risk of implantation related vitreous hemorrhage. Vitreous hemorrhages occurring greater than one year from implantation could be a sign of ENCELTO extrusion. The surgical site should be examined closely and the ENCELTO should be surgically repositioned if indicated.

( 5.4 )

5.1Severe Vision Loss Severe vision loss defined as three or more lines of visual acuity loss [≥15 Early Treatment Diabetic Retinopathy Study (ETDRS) letters] has occurred following ENCELTO implantation [ see Adverse Reactions (6) ]. Monitor patients for signs and symptoms of vision loss and manage as clinically indicated.

5.2Infectious Endophthalmitis Infectious endophthalmitis may occur following ENCELTO implantation. Signs and symptoms of infectious endophthalmitis include progressively worsening eye pain, vision loss, or scleral and conjunctival injection. To mitigate the risk of endophthalmitis, use proper aseptic surgical technique for ENCELTO implantation [ see Dosage and Administration (2.2) ].

Monitor patients for signs or symptoms of infectious endophthalmitis. Remove ENCELTO implant if infectious endophthalmitis occurs and manage symptoms according to clinical practice.

5.3Retinal Tear and Detachment Retinal tears and retinal detachment may occur following ENCELTO implantation. Signs and symptoms of retinal tears include acute onset of flashing lights, floaters, and/or loss of visual acuity. Signs and symptoms of retinal detachment may include progressive visual field loss and/or loss of visual acuity.

Use standard vitreoretinal surgical techniques during ENCELTO implantation to minimize the risk of retinal tears and retinal detachment. Monitor for any signs or symptoms of retinal tear and/or retinal detachment. Treat rhegmatogenous retinal detachment and retinal tears promptly.

Remove ENCELTO implant, if vitrectomy with a complete gas fill or silicone oil fill is required [ see Dosage and Administration (2.3) ].

5.4Vitreous Hemorrhage Vitreous hemorrhage, which may result in temporary vision loss, has occurred following ENCELTO implantation [ see Adverse Reactions (6) ]. Patients receiving antithrombotic medication (e.g., oral anticoagulants, aspirin, nonsteroidal anti-inflammatory drugs) may be at increased risk of vitreous hemorrhage. To reduce the risk of vitreous hemorrhage, interrupt antithrombotic medications prior to the ENCELTO implantation.

Vitrectomy surgery may be necessary to clear severe, recurrent, or non-clearing vitreous hemorrhage. If the patient has a late onset vitreous hemorrhage (greater than one year following ENCELTO implantation surgery), examine the ENCELTO implantation site for possible implant extrusion. If implant extrusion has occurred, surgically reposition ENCELTO [ see Implant Extrusion (5.5) ].

5.5Implant Extrusion Implant extrusion through the initial scleral wound has occurred following ENCELTO implantation [ see Adverse Reactions (6) ]. Signs and symptoms of implant extrusion include recurrent uveitis, vitreous hemorrhage, eye pain more than one year after implantation, or visibility of titanium fixation loop under the conjunctiva. To reduce the risk of implant extrusion, carefully follow the specific surgical steps for ENCELTO implantation [ see Dosage and Administration (2.2) ].

Evaluate patients after 6 months to confirm proper positioning of ENCELTO and then annually. If ENCELTO begins to e… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~2 min read ▾

6 ADVERSE REACTIONS The most common adverse reactions (incidence ≥2%) were conjunctival hemorrhage, delayed dark adaptation, foreign body sensation, eye pain, suture related complications, miosis, conjunctival hyperemia, eye pruritus, ocular discomfort, vitreous hemorrhage, blurred vision, headache, dry eye, eye irritation, cataract progression or formation, vitreous floaters, severe vision loss, eye discharge, anterior chamber cell, iridocyclitis. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Neurotech at 1- 833-963-9275 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety data described in this section reflects exposure to ENCELTO in two clinical trials, Study 1 (NTMT-03-A) and Study 2 (NTMT-03-B) and are pooled for analysis. A total of 117 patients received ENCELTO, and 111 patients underwent a sham procedure and were followed for a duration of 24 months [ see Clinical Studies (14) ].

Serious adverse reactions occurred in six patients (5%) including suture related complications (n=5) and implant extrusion (n=1). Table 1 lists the most common adverse reactions that occurred in > 2% patients and with higher frequency in ENCELTO group compared to Sham group in Study 1 and Study 2. Table 1.

Adverse Reactions occurring in ≥2% of Patients and with higher frequency in ENCELTO group compared to Sham group in ENCELTO studies* Adverse Reactions ENCELTO (N=117) n (%) Sham (N=111) n (%) Conjunctival hemorrhage 36 (31) 29 (26) Delayed dark adaptation 27 (23.1) 1 (1) Foreign body sensation in eyes 18 (15) 15 (13.5) Eye pain 18 (15) 10 (9) Suture related complication** 18 (15.4) 3 (2.7) Miosis 18 (15.4) 0 (0.0) Conjunctival hyperemia 13 (11) 9 (8) Eye pruritus 10 (9) 4 (3.6) Ocular discomfort 10 (9) 1 (1) Vitreous hemorrhage 10 (8.5) 0 (0.0) Vision blurred 8 (7) 4 (4) Headache 8 (7) 1 (1) Dry eye 7 (6) 2 (2) Eye irritation 6 (5.1) 2 (2) Cumulative cataract incidence 6 (5) 0 (0) Vitreous floaters 6 (5) 0 (0.0) Severe visual loss>15 letters*** 4 (3) 0 (0) Eye discharge 4 (3.4) 1 (0.9) Anterior chamber cell 4 (3.4) 0 (0.0) Iridocyclitis 3 (2.6) 0 (0) * Pooled data from Study 1 and Study 2; Adverse reaction rates were comparable between the two studies **Suture related complications include exposed suture, foreign body sensation, conjunctival wound dehiscence, painful sutures, suture irritation, suture granuloma, scleral wound opening, and itchy suture *** Includes one case of visual loss due to cataract formation which remained unresolved at the end of the study

👥 Use in Specific Populations ~1 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary There are no data on the use of ENCELTO in pregnant women. Endogenous CNTF is naturally found in maternal plasma, placental cells, and umbilical cord blood. It is not known if the use of ENCELTO increases CNTF above naturally occurring levels in these tissues.

In animal reproduction studies, subcutaneous administration of rhCNTF to pregnant rats and rabbits demonstrated no evidence of teratogenic effects on the fetus. However, when administered to rabbits at a dose level of 10ug/kg/day, a decrease in implantations and live fetuses was observed. When administered to rats at a dose level of 100ug/kg/day a decrease in corpora lutea was observed.

The estimated background risk of major birth defects and miscarriage in the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects is 2% to 4% and of miscarriage is 15% to 20% of clinically recognized pregnancies.

Data Animal Data See Risk Summary for details on data .

8.2Lactation Risk Summary There is no data on the presence of ENCELTO in human milk, its effects on the breastfed infant, or its impact on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for ENCELTO and any potential adverse effects on the breastfed infant from rhCNTF or from the underlying maternal condition.

8.4Pediatric Use The safety and effectiveness of ENCELTO have not been established in pediatric patients.

8.5Geriatric Use There were 38 patients (32%) 65 years of age and older and two patients (1%) 75 years of age and older in Study 1 and Study 2 who received ENCELTO [ see Clinical Studies (14) ]. Clinical studies of ENCELTO did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently than younger patients.

🧬 Clinical Pharmacology ~1 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action ENCELTO secretes recombinant human ciliary neurotrophic factor (rhCNTF), which is one of several neurotrophic factors endogenously produced by neurons and supporting glial cells. Exogenous CNTF is thought to initially target Müller glia to trigger a cascade of signaling events that may promote photoreceptor survival; however, the mechanism of action for ENCELTO is not completely understood.

12.3Pharmacokinetics Systemic exposure of rhCNTF was measured in 2 distribution studies in rabbits and in 2 toxicology studies in minipigs. Overall, there was no evidence of systemic exposure to rhCNTF after implantation of ENCELTO in rabbits for periods up to 9 months or in minipigs for periods of up to 6 months. Following intraocular implantation of a single ENCELTO dose in rabbits at 12 weeks, the mean C max of rhCNTF in the vitreous and aqueous was 2.0 and 0.3 ng/mL, respectively, and below the level of quantitation (LLOQ) in the serum and contralateral, untreated eye.

Similarly in human patients, rhCNTF levels were below the limit for LLOQ in the serum.

12.6Immunogenicity The observed incidence of anti-drug antibodies is highly dependent on the sensitivity and specificity of the assay. Differences in assay methods preclude meaningful comparisons of the incidence of anti-drug antibodies in the studies described below with the incidence of anti-drug antibodies in other studies, including those of ENCELTO or of other products. In a six-month Study NTMT-02B in which patients received ENCELTO in a single eye, one out of 31 patients (3%) tested positive for serum antibodies against the ENCELTO secreted product protein rhCNTF and one patient (3%) tested positive to serum non-secreted intracellular protein DHFR.

Because of the low occurrence of anti-drug antibodies, the effect of serum anti-rhCNTF and anti-DHFR antibodies on the safety or efficacy of ENCELTO is unknown.

📦 How Supplied / Storage and Handling ~2 min read ▾

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1How Supplied ENCELTO is supplied as a sterile, single-dose, implant that contains 200,000 to 440,000 allogeneic retinal pigment epithelial cells expressing rhCNTF (NTC-201-6A cell line). ENCELTO is packaged in a protective inner container within an Endothelial Serum Free Media (Endo-SFM), which is maintained sterile by a sealed outer container. ENCELTO is provided attached to a gripper that both suspends ENCELTO in the Endo-SFM and facilitates intraocular insertion.

ENCELTO contains no preservatives. NDC: 82958-501-01 See Table 4 , ( Figure 16 ) and ENCELTO “Instructions for Use” for additional details. Table 4.

ENCELTO Corepack Contents Components Description Inner container This is provided sterile. It is a cylindrical plastic container with a lower compartment filled with liquid medium. It has an upper compartment connected to it via a narrow channel that is secured shut with a luer lock cap.

Outer container This is a plastic container with a foil lid hermetically sealed. It maintains the sterility of the inner container until ready to use. Disposable temperature recording device A disposable device that measures and records the temperature in the package.

If ENCELTO has been stored within the acceptable range, a “✓” will be shown at the top of the screen. If an “X” is displayed, ENCELTO has been exposed to temperatures outside of the acceptable range and must not be used. ENCELTO Medium pH Color Guide A card that provides a color scale to indicate the acceptable pH range for the liquid medium.

ENCELTO Instructions for Use A booklet that contains the full instructions and includes the ENCELTO patient card. ENCELTO Inspection Checklist An information sheet that contains instructions for inspection prior to use. USPI United States Prescribing Information.

Figure 16. ENCELTO Corepack Contents Figure 17. ENCELTO Figure 18.

ENCELTO Inner Container Figure 19. pH Color Guide image description image description image description image description

16.2Storage and Handling 1. Using the handle, remove the corepack from the larger shipping box ( Figure 16 ). 2.

Store ENCELTO in the corepack at 16º to 37ºC (61º to 99ºF) until ready for use. 3. Do not freeze or refrigerate.

4. Inspect the disposable temperature recording device. If a check mark is displayed, the ENCELTO has remained within the acceptable temperature range and may be used.

If a “X” is displayed, the ENCELTO was exposed to temperatures outside the acceptable range and must not be used. Contact Neurotech immediately at (833)-963-9275. • Protect ENCELTO from light. 5.

Handle inner container ( Figure 18 ) using sterile technique. 6. Do not use beyond the “use by” date identified on the corepack label.

7. Do not use ENCELTO if the pH is not within the acceptable range ( Figure 19 ). Contact Neurotech immediately at (833)-963-9275. • Prior to disposal of an ENCELTO implant per local institutional protocols, call 1-833-963-9275 for assessment of ENCELTO return or replacement.

Orange to pink liquid hold medium referred to as Endothelial Serum Free Media (Endo-SFM) within packaging inner container may contain visible particles. Particle general description fiber, solid, white, or metallic in appearance.

📋 Description 208 words ▾

11 DESCRIPTION ENCELTO (revakinagene taroretcel-lwey) implant, is single-dose, sterile, nonpyrogenic and retrievable. ENCELTO is an allogeneic encapsulated cell-based gene therapy that contains 200,000 to 440,000 allogeneic retinal pigment epithelial cells expressing recombinant human ciliary neurotrophic factor (rhCNTF) (NTC-201-6A cell line) for surgical intravitreal placement. ENCELTO consists of an opaque, semi-permeable white to off-white capsule surrounding a scaffold of polyethylene terephthalate (PET) yarn, loaded with rhCNTF secreting allogeneic retinal pigment epithelial cells (NTC-201-6A cell line).

Each end of the semi-permeable capsule is sealed with medical grade methacrylate adhesive, and to one end a titanium fixation loop is attached. ENCELTO width is 1.2 ± 0.1 mm, length is 6.1 ± 0.4 mm, and its internal diameter is 0.88 ± 0.02 mm ( Figure 17 ). ENCELTO is packaged in a protective inner container within an orange to pink liquid hold medium referred to as Endothelial Serum Free Media (Endo-SFM), which is maintained sterile by a sealed outer container.

ENCELTO is provided attached, by the fixation loop, to a gripper that both suspends ENCELTO in the Endo-SFM and facilitates intraocular insertion. The Endo-SFM within the packaging inner container may contain visible particles generally described as fiber, solid, white, or metallic in appearance. ENCELTO is manufactured using animal and human derived reagents.

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES The efficacy of ENCELTO was evaluated in two studies, Study NTMT-03-A ( NCT03316300 ; Study 1) and Study NTMT-03-B ( NCT03319849 ; Study 2) as described below. Study 1 Study 1 was a randomized, multi-center, sham-controlled study which enrolled adults with MacTel. For enrollment, the patients were required to have a photoreceptor inner segment/outer segment (IS/OS PR) break (loss) in ellipsoid zone (EZ) between 0.16 and 2.00 mm 2 measured by spectral domain-optical coherence tomography (SD-OCT) and best corrected visual acuity (BCVA) of 54-letter score or better (20/80 or better) as measured by the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at screening.

Patients with neovascular MacTel were excluded. Patients were randomized to receive either ENCELTO intravitreal implant or sham procedure under standard operative procedures. Patients in ENCELTO group underwent conjunctival peritomy, implant placement in the vitreous cavity via sclerotomy and closure with sutures.

Patients in the Sham group underwent conjunctival peritomy, scleral pressure, and conjunctival closure with sutures. One hundred and fifteen (96%) of 120 patients underwent the assigned procedure and were included in the analysis of efficacy. A total of 120 patients were randomized and of these, 115 patients (ENCELTO group: 58; Sham group: 57) comprise the efficacy analysis population.

The demographic characteristics of the efficacy analysis population were as follows: the mean age was 61 years (range 40 to 78 years), 79 patients (69%) were female, 98 patients (85%) were White, 5 patients (4%) were Asian, 3 patients (3%) were Black or African American, 1 patient (1%) was American Indian, and 8 patients (7%) were of “other” race. Six patients (5%) were Hispanic. The median (min, max) baseline EZ area loss was 0.35 (0.15, 1.99) mm 2 for the ENCELTO group and 0.36 (0.16, 1.7) mm 2 for the Sham group.

The median (min, max) baseline aggregate sensitivity of microperimetry within the EZ break area 35.2 (0.75, 398.8) dB for the ENCELTO group and 35.5 (2, 281.3) dB for the Sham group. The primary efficacy outcome measure was the rate of change in the area of EZ loss (IS/OS, macular PR loss) over 24 months, as measured by SD-OCT. The secondary outcome measure was the mean change in aggregate sensitivity loss of microperimetry within the EZ break area from baseline to Month 24.

The efficacy outcome results for Study 1 are summarized in Table 2 . Table 2. Efficacy Results for Study 1 (N=115) Efficacy endpoints ENCELTO n= 58 Sham n=57 Difference ENCELTO-Sham P-value c Rate of change in EZ area loss from baseline over 24 months a mm 2 (95% CI) 0.075 (0.05, 0.10) 0.166 (0.14, 0.19) -0.091 (-0.13, -0.06) <0.0001 Mean change in aggregate retinal sensitivity loss from baseline to 24-months b dB (95% CI) 25.27 (15.88, 34.67) 43.02 (31.78, 54.26) -17.75 (-32.58, -2.91)

0.02CI = confidence interval, EZ=ellipsoid zone a Estimated by using a longitudinal mixed model including EZ area loss as the dependent variable, patient-specific random intercepts, treatment group, time (continuous), and interaction between treatment and time as covariates. The baseline and Months 12, 16, 20, and 24 visits were included. b Estimated by using two-sample t-test; seven ENCELTO and four Sham patients were excluded due to missing data. c Statistically significant at two-sided alpha of 0.05. Study 2 Study 2 was a randomized, multi-center, sham-controlled study which enrolled adult with MacTel.

For enrollment, the patients were required to have an IS/OS PR break in EZ between 0.16 and 2.00 mm 2 measured by SD-OCT and BCVA of 54-letter score or better (20/80 or better) as measured by the ETDRS chart at screening. Patients with neovascular MacTel were excluded. Patients were randomized to receive either ENCELTO intravitreal implant or sham procedure under standard peri-operative procedures.

Patients in ENCELTO group underwent conjunctival peritomy, implant placement in the vitr… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology 50 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis and Mutagenesis No carcinogenicity or mutagenicity studies have been conducted with rhCNTF. Impairment of Fertility In male rats, fertility was unaffected at subcutaneous doses of rhCNTF up to 300 μg/kg/day. See Pregnancy (8.1) for data regarding effects on female fertility.

📄 Patient Package Insert ~3 min read ▾

PATIENT INFORMATION ENCELTO (En-SEL-toh) A surgical implant for use in the eye What is ENCELTO? ENCELTO is an encapsulated cell-based gene therapy. It is a small capsule, about the size of a grain of rice, that is placed inside the eye to release a protein called recombinant human ciliary neurotrophic factor (rhCNTF) that can directly reach the retina, the light sensitive part of the eye.

The capsule contains living cells that have been genetically modified to continuously produce and release CNTF. This protein helps protect certain cells in your retina, supporting their health and reducing the loss of light-sensing cells known as photoreceptors. ENCELTO is used to treat adults with idiopathic macular telangiectasia type 2 (MacTel); a retinal disease that causes progressive vision loss.

Your ophthalmologist will assess your vision and review your medical history to determine if ENCELTO is the right treatment for you. Who should not receive an ENCELTO surgical implant? ENCELTO has not been tested in pediatric patients or pregnant women.

The outpatient surgical procedure should not be performed if you are currently experiencing an active or suspected eye infection. You should not receive ENCELTO if you have a known hypersensitivity to Endothelial Serum Free Media (Endo-SFM) Before receiving ENCELTO, tell your ophthalmologist about all your medical conditions, including: Are pregnant or plan to become pregnant. Although studies have shown that rhCNTF does not enter the bloodstream, its effects on an unborn baby have not been fully studied.

Are breastfeeding or plan to breastfeed. It is not known if rhCNTF passes into your breast milk. Any current infections Are currently taking or have recently taken medicines that lower the chance of blood clots forming in the body such as warfarin, low or regular doses of aspirin, or nonsteroidal anti-inflammatory drugs (NSAID) How is ENCELTO administered?

ENCELTO is inserted into the eye as an outpatient surgical procedure performed by an ophthalmologist experienced in retinal surgery. If removal of ENCELTO is necessary, the removal surgery must also be done by an ophthalmologist experienced in vitreoretinal surgery in an operating room as an outpatient surgery. What should I avoid after placement of ENCELTO?

Immediately post-operative: Avoid heavy lifting (over 20 pounds) for one week. Keep water out of the eye (e.g., close your eye while showering) for one week. Protect your eyes by wearing glasses or protective eyewear during the day and using an eye shield at night for one week.

Do not drive or use machinery until the eye shield has been removed and your ophthalmologist informs you that your vision has recovered to an acceptable level. Post operative care: Use a topical antibiotic solution at a frequency of 1 drop four times a day for 7 days. Use a steroid drop taper of prednisolone acetate 1% (or equivalent) starting the day after surgery with the following taper: 1 drop four times a day for the first 7 days; 1 drop three times a day for the next 7 days; 1 drop two times a day for the next 7 days; 1 drop once a day for the last 7 days.

Magnetic Resonance (MR) Conditional Information IMPORTANT: ENCELTO is MR conditional. You will receive an implant card, which should be shown to your imaging technician if you need Magnetic Resonance Imaging (MRI) at any time while the ENCELTO implant is in your eye. The card will include details about the ENCELTO implant, the date of insertion, and on the back, instructions for the imaging technician to access important MRI safety information.

Call your ophthalmologist for medical advice about side effects. You may report side effects to the Food and Drug Administration (FDA) at 1-800-FDA-1088. What are the possible side effects of ENCELTO?

Please follow all post-operative instructions given by your ophthalmologist and ensure you attend all follow-up visits as recommended. Potential side effects Please be advised that ENCELTO and the surgical insertion has… [Excerpted — this section continues on DailyMed.]

📖 Instructions for Use 107 words ▾

Instructions for Use image description image description image description image description image description image description image description image description image description image description image description image description image description image description image description image description image description image description image description image description image description image description image description image description image description image description image description image description image description image description image description image description image description image description image description image description image description image description image description image description image description image description image description image description image description image description image description image description image description image description image description image description

📄 Package Label / Principal Display Panel 10 words ▾

ENCELTO PRODUCT LABEL image description

ENCELTO COREPACK LABEL image description

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for ENCELTO (this brand).

Top reported reactions

Visual Impairment2
Vitreoretinal Traction Syndrome2
Vitreous Haemorrhage2
Blindness Unilateral1
Depression1
Eye Pain1
Limb Injury1

Reporter sex

6 reports
Male · 83%
Female · 17%

Serious outcomes

Hospitalization1
Disabling1
Reports over time (by year) — tap or hover for the count & year
2025 2026 6 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Neurotech Pharmaceuticals, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Neurotech Pharmaceuticals, Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 82954-0100-01 · Harm 82959-0111-01 · Geron →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.