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iDose TR Travoprost Intracameral 75 ug Implant, 1 implant — NDC 25357-0100-99 package photo

iDose TR Travoprost Intracameral 75 ug Implant, 1 implant

by Glaukos Corporation · 1 POUCH in 1 CARTON (25357-100-99) / 1 TRAY in 1 POUCH / 1 CANISTER in 1 TRAY / 1 IMPLANT in 1 CANISTER
NDC 25357-0100-99
🏷️ FDA NDC (as labeled) 25357-100-99 billing pads the product segment with a zero
This package
Contains1 implant Pack sizes2 compare ↓
Also comes in: 1 implant 25357-0100-01
Rx only Brand On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

🆔 Identity & classification

FDA NDC (as labeled) 25357-100-99
Product NDC 25357-100
11-digit billing NDC 25357010099
RxCUI 2672088, 2672093
UNII WJ68R08KX9
Application # NDA218010
SPL Set ID 92f6d3e2-8328-47df-972c-23008f4a1c1c
Established class (EPC) Prostaglandin Analog
Chemical class Prostaglandins
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2023-12-13
Route INTRACAMERAL
Dosage form IMPLANT
Substance TRAVOPROST
GPI-14 86330070002320
GCN Seq No 085598
GCN 55112
HICL code 021996
Ingredient (HICL) Travoprost
HIC1 code Q
Therapeutic class — broad (HIC1) Ear/Eye/Nose/Rectum/Topical/Vagina/Other
HIC2 code Q6
Therapeutic class — intermediate (HIC2) Ophthalmic Preparations
HIC3 code Q6G
Therapeutic class — specific (HIC3) Miotics And Other Intraocular Pressure Reducers
AHFS code 52:40.28.00
AHFS class Prostaglandin Analogs
FDB label name IDOSE TR 75 MCG IMPLANT
FDB brand name Idose Tr
Legend status F — Federal legend — prescription drug or device
Why two NDCs? The FDA registers this code as 25357-100-99 — 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 → 25357-0100-99. 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.

🏷️ RxNorm drug class

This medicine belongs to the Prostaglandin Analog class.

Pharmacologic class Prostaglandin Analog
Drug family (ATC) Prostaglandin analogues
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerGlaukos Corporation
Application holderGLAUKOS CORP
FDA applicationNDA218010 (NDA)
Labeler code25357
First marketedDec 2023
Product typeHuman Prescription Drug
Portfolio3 products on file
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.

🩺 Clinical

Label name IDOSE TR 75 MCG IMPLANT Ingredient Travoprost
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.

🧪 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.

💲 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.
Try another pack size: 1 implant
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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
iDose TR 75 ugthis 25357-0100-99 Glaukos 1 implant FDA listed
About this product: this is the brand-name version. We did not find an FDA-approved generic match for this exact strength, form and route.
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 & generic status

🏛️
2023
First FDA approval
Dec 2023
📍
2026
Currently FDA-listed
3 years listed
🛡️
2031
Latest patent/protection listed
not a guaranteed launch date
🔒No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route. Patent/protection dates below may affect future generic timing.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Feb 2031. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Dec 13, 2023 RLD RS ⏳ ~4.4 yr to latest listed protection

Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.

Patents & exclusivity — FDA Orange Book
US 12201557 — drug substance (U-4129)
US 11426306 — drug product
US 10206813 — drug product
US 12201555 — drug substance
Exclusivity NP
2023 2025 2027 2029 2031
Today
LOE
Substance patent Formulation patent Method-of-use patent Exclusivity Pediatric +6mo
🏛️FDA exclusivity
FDA-granted marketing protection. It’s separate from patents and may be shorter than patent protection.
🧪Product / substance patents
Patents covering the active ingredient, product, formulation, or related drug features.
🎯Method-of-use patents
Patents covering specific approved uses. These can sometimes be carved out with a “skinny label,” but not always.
🛈 What do these terms mean?
Patent
Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
Substance patent
Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
Formulation (product) patent
Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
Method-of-use patent
A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
Skinny label
A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
Exclusivity
FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
Paragraph IV
A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
RLD / RS
Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
TE / AB rating
FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
LOE (loss of exclusivity)
The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.

Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.

Listed patents (4)
PatentTypeUse codeExpires
US 12201557 ↗ Drug substance U-4129 Jun 18, 2030
US 11426306 ↗ Drug product Oct 17, 2030
US 10206813 ↗ Drug product Oct 17, 2030
US 12201555 ↗ Drug substance Feb 14, 2031
FDA exclusivity
CodeWhat it grantsExpires
NPNew ProductDec 13, 2026
Common questions
Is there a generic version of IDOSE TR 75 MCG IMPLANT?
No FDA-approved generic equivalent is currently listed in the FDA Orange Book for IDOSE TR 75 MCG IMPLANT. Based on the patents and exclusivity currently listed, the Orange Book estimate is that full-label generic entry may be delayed until Feb 2031 — an estimate, not a guaranteed launch date.
The FDA approved a generic — why can’t I get it at my pharmacy yet?
FDA approval and pharmacy availability are two different things. The FDA can approve a generic years before it actually reaches pharmacies, because the brand company may still hold patents or have a settlement that delays the launch. A manufacturer also has to choose to make and sell it, and have supply ready. So a drug can be “FDA-approved generic exists” and still be brand-only at the counter today.
Why do different websites show different generic release dates?
Generic availability is not based on one single date. Some sources use the first exclusivity expiration, some use the last product patent, and others use the latest method-of-use patent. Patent challenges, settlements, licenses, and label carve-outs can also change the real-world launch date. This page shows the underlying Orange Book dates so you can see why estimates may differ.
What does “FDA listed” mean?
It means the product appears in the FDA’s official NDC directory. That’s a good sign a product exists and is intended for the U.S. market, but on its own it does not confirm a pharmacy can fill it today. Where we have recent retail pricing data (NADAC) for a product, 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 Orange Book for a patent or exclusivity on the brand product. It can affect when a full generic version becomes widely available — but it is not a guaranteed generic launch date. Generics sometimes arrive earlier (through a settlement or patent challenge) or later (a manufacturer still has to make and sell one).
What does “current Orange Book estimate” mean?
It means we are using the latest patent and exclusivity dates currently listed in the FDA Orange Book. It is not a guaranteed launch date.
Can a generic come out before the last patent expires?
Sometimes. A generic company may challenge a patent, settle with the brand manufacturer, receive a license, or obtain approval with a narrower label that avoids a patented use. In other cases, the last listed protection may delay full-label generic competition.
Can a generic come out after the listed dates?
Yes. Even after patents or exclusivity expire, a generic still needs FDA approval and a manufacturer must choose to market it. Supply, litigation, business decisions, or regulatory issues can delay actual availability.
What is the difference between patents and exclusivity?
Patents are legal protections usually issued by the U.S. Patent and Trademark Office. FDA exclusivity is marketing protection granted by the FDA. They are separate, and either one can affect generic timing.
Why are there multiple patent dates?
One drug can have several patents covering different things: the active ingredient, a formulation, a manufacturing process, or a specific approved use. That is why a page may show several expiration dates instead of one simple generic date.
Built from FDA Orange Book patent and exclusivity data. Dates are refreshed from public FDA data when available; the marker is max(latest patent expiry, latest exclusivity expiry). Paragraph-IV settlements and first-filer 180-day exclusivity can shift the real date; a method-of-use patent may allow an earlier skinny-label generic for non-protected indications. Generic launch timing is an estimate, not a guarantee.
Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

💊 Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
1 implant25357-0100-01 15 Rx · $53,144
Drug total (last 4 qtrs): 15 Rx · 15 units · $53,144 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

🔬 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 Travoprost Intracameral — the ingredient across all brands.

Top reported reactions

Medical Device Removal29
Intraocular Pressure Increased26
Device Dislocation15
Eye Pain12
Iritis11
Cystoid Macular Oedema8
Eye Inflammation8

Reporter sex

94 reports
Reports over time (by year) — tap or hover for the count & year
2024 2025 2026 47 10
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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
25357-0100-01 1 POUCH in 1 CARTON (25357-100-01) / 1 TRAY in 1 POUCH / 1 CANISTER in 1 TRAY / 1 IMPLANT in 1 CANISTER 2023-12-13 Active
25357-0100-99 You're viewing this 1 POUCH in 1 CARTON (25357-100-99) / 1 TRAY in 1 POUCH / 1 CANISTER in 1 TRAY / 1 IMPLANT in 1 CANISTER 2026-02-17 Active

Pack size FAQ

What quantity is in NDC 25357-0100-99?
NDC 25357-0100-99 contains 1 implant — 1 pouch in 1 carton / 1 tray in 1 pouch / 1 canister in 1 tray / 1 implant in 1 canister.
What is the difference between NDC 25357-0100-99 and NDC 25357-0100-01?
Both are iDose TR Travoprost Intracameral 75 ug Implant — the drug itself is identical. NDC 25357-0100-99 is the 1 implant package, while NDC 25357-0100-01 is the 1 implant package.
What NDC number is used to bill for this package of iDose TR Travoprost Intracameral 75 ug Implant?
Bill NDC 25357-0100-99 — the 11-digit billing format is 25357010099. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 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 FDA registers it as 25357-100-99, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 25357-0100-99, written without dashes as 25357010099. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 25357-0100-99, the first segment (25357) is the labeler code FDA assigned to Glaukos Corporation; the middle segment (0100) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (99) identifies this exact package size and type. Together they name one specific package of one specific product.
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 Glaukos Corporation. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 1 implant (25357-0100-01). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Glaukos Corporation 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.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage 57 words

1 INDICATIONS AND USAGE iDose ® TR (travoprost intracameral implant) is indicated for the reduction of intraocular pressure (IOP) in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT). iDose ® TR is a prostaglandin analog indicated for the reduction of intraocular pressure (IOP) in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT) ( 1 )

⏱️ Dosage and Administration ~3 min read

2 DOSAGE AND ADMINISTRATION For ophthalmic intracameral administration ( 2.1 ) The intracameral administration should be carried out under standard aseptic conditions ( 2.2 )

2.1General Dosing Information iDose TR is a travoprost delivery system consisting of a travoprost releasing implant pre-loaded in a sterile, single-dose inserter. iDose TR is administered intracamerally through a small, clear corneal incision and is anchored into the sclera at the iridocorneal angle.

2.2Administration Instructions 1. The procedure must be carried out under aseptic conditions which include use of sterile gloves and a sterile drape. 2.

The eye should be anesthetized using general, retrobulbar, peribulbar, or topical anesthesia per standard operating room procedures. 3. The iDose TR implantation procedure must be performed under magnification that allows clear visualization of the anterior chamber angle and angle structures including trabecular meshwork, with the patient's head in a stabilized position.

The pupil should not be dilated prior to the procedure. 4. An intracameral miotic can be injected to deepen the angle prior to insertion of the iDose TR.

5. It is recommended that the implant surgery be performed from the temporal side, using a temporal clear corneal incision. The implant will be implanted through the angle and the trabecular meshwork into the sclera on the nasal side.

6. Remove the barrier pouch from the carton and examine for damage. Open the barrier pouch, discard the oxygen scavenger packet, and remove the blister tray with Tyvek ® lid.

Open the Tyvek lid containing the iDose TR pre-loaded inserter and present to the surgeon. The iDose TR implant and single-dose inserter should be handled in the sterile field. Caution: Do not use the iDose TR if the Tyvek lid has been opened or the packaging appears damaged.

7. Prepare for gonioscopy by turning the patient's head away from the surgeon by approximately 15° to 25° and tilt the scope toward the surgeon by approximately 35°. The total combined angle should be approximately 50° to 60°.

8. Place a small amount of viscoelastic on the cornea. Position the gonioprism on the cornea using light touch gonioscopy.

Adjust the microscope to locate and focus on the trabecular meshwork. 9. Inspect the angle with a gonioprism to ensure that a good view of all angle structures is available at the nasal implant location.

10. Hold the single-dose inserter with your index finger comfortably on the implant release button (see Figure 1 ) Figure 1 11. Perform a detailed inspection of the tip of the sterile inserter under magnification to ensure that the iDose TR implant is present (see Figure 2 ).

Figure 2 12. Create a clear corneal incision of approximately 2.4 mm at the temporal limbus location using an instrument of the surgeon's choice. 13.

Add a cohesive viscoelastic to the anterior chamber as needed to form the anterior chamber and improve visualization of the angle. Be careful not to overinflate. 14.

Insertion of the implant: a. When ready for implantation, remove the safety clip which holds the release button in place by squeezing and rocking the clip backwards (see Figure 2 ). Place finger on the release button to ensure it remains in the forward position and does not prematurely release the implant. b.

To smoothly enter the anterior chamber, slide the inserter tip with implant "side to side" in the incision. c. Advance to the pupillary margin and ensure there is sufficient cohesive viscoelastic on the cornea before replacing the gonioprism onto the cornea. d. Take care to avoid contact with the lens or cornea. e.

Advance to the anterior chamber angle and approach the trabecular meshwork (see Figure 3 ). Figure 3 f. Press the implant directly through the trabecular meshwork, compressing the tissue until the implant anchor securely penetrates the sclera through the back wall of Schlemm's canal.

The base of the implant reservoir should be firmly in contact with and compressing the trabec…

💊 Dosage Forms and Strengths 30 words

3 DOSAGE FORMS AND STRENGTHS Intracameral implant containing 75 mcg travoprost, pre-loaded in a single-dose inserter. Intracameral implant containing 75 mcg travoprost, pre-loaded in a single-dose inserter ( 3 )

Contraindications 114 words

4 CONTRAINDICATIONS Ocular or periocular infections ( 4.1 ) Corneal endothelial dystrophy ( 4.2 ) Prior corneal transplantation ( 4.3 ) Hypersensitivity ( 4.4 )

4.1Ocular or Periocular Infections iDose TR (travoprost intracameral implant) is contraindicated in patients with active or suspected ocular or periocular infections .

4.2Corneal Endothelial Dystrophy iDose TR is contraindicated in patients with corneal endothelial cell dystrophy (e.g., Fuch's Dystrophy, corneal guttatae).

4.3Prior Corneal Transplantation iDose TR is contraindicated in patients with prior corneal transplantation, or endothelial cell transplants (e.g., Descemet's Stripping Automated Endothelial Keratoplasty [DSAEK]).

4.4Hypersensitivity iDose TR is contraindicated in patients with hypersensitivity to travoprost or to any other components of the product .

⚠️ Warnings and Cautions ~3 min read

5 WARNINGS AND PRECAUTIONS Iridocorneal Angles : iDose TR should be used with caution in patients with narrow angles or other angle abnormalities ( 5.1 ) Device Dislocation : Monitor patients routinely to confirm the location of the iDose TR at the site of administration ( 5.2 ) Pigmentation : Increased pigmentation of the iris can occur. Iris pigmentation is likely to be permanent ( 5.8 )

5.1Iridocorneal Angles iDose TR should be used with caution in patients with narrow iridocorneal angles (Shaffer grade < 3) or other angle abnormalities (e.g., peripheral anterior synechia, rubeosis iridis) that could impair proper placement of iDose TR at the planned implantation site.

5.2Device Dislocation Dislocation of the iDose TR has been observed in clinical trials. Patients should be monitored routinely to confirm the location of the iDose TR at the site of administration. If the iDose TR implant becomes dislocated, it should be surgically removed [see Dosage and Administration (2.3 , 2.4) ] .

5.3Patients without Baseline Corneal Endothelial Cell Density Prior to Initial Administration It is not recommended to readminister iDose TR if baseline central corneal endothelial cell density was not established prior to initial administration of iDose TR [see Warnings and Precautions (5.4 , 5.5) ] .

5.4Recommended Minimum Corneal Endothelial Cell Density for Readministration Central corneal endothelial cell density should not be less than the recommended minimum listed in Table 2 prior to the initial administration of iDose TR and prior to each readministration. If corneal endothelial cell density was not established prior to the initial administration of iDose TR and only a single eye was implanted, corneal endothelial cell density in the un-implanted contralateral eye meeting the recommended minimum density may be used for eligibility determination for readministration of iDose TR (see Table 2 ).

Table 2: Recommended Minimum Central Corneal Endothelial Cell Density Central Corneal Endothelial Cell Density Age Phakic Eyes Pseudophakic Eyes ≤ 45 years 2,200 (cells/mm 2 ) 1,540 (cells/mm 2 ) 46 to 55 years 2,000 (cells/mm 2 ) 1,400 (cells/mm 2 ) 56 to 65 years 1,800 (cells/mm 2 ) 1,260 (cells/mm 2 ) > 65 years 1,600 (cells/mm 2 ) 1,120 (cells/mm 2 )

5.5Corneal Endothelial Cell Loss iDose TR should be readministered with caution in eyes with 10% or greater loss in central corneal endothelial cell density from pre-administration baseline (adjusted for age-related 1% loss per year and for a 10% loss following an anterior segment surgical procedure [e.g., cataract surgery]). If baseline corneal endothelial cell density was not established prior to the initial administration of iDose TR and only a single eye is implanted, a 10% threshold level of endothelial cell density loss as a difference of the implanted eye versus un-implanted contralateral eye should be considered before readministering iDose TR.

5.6Macular Edema Macular edema, including cystoid macular edema, has been reported during treatment with ophthalmic travoprost, including iDose TR intracameral implant. iDose TR should be used with caution in aphakic patients, in pseudophakic patients with a torn posterior lens capsule, or in patients with known risk factors for macular edema.

5.7Intraocular Inflammation Prostaglandin analogs, including iDose TR, have been reported to cause intraocular inflammation. iDose TR should be used with caution in patients with active intraocular inflammation (e.g., uveitis) because the inflammation may be exacerbated.

5.8Pigmentation Topical ophthalmic travoprost has been reported to cause increased pigmentation to pigmented tissues. Pigmentation is expected to increase as long as travoprost is administered. The pigmentation change is due to increased melanin content in the melanocytes rather than to an increase in the number of melanocytes. After discontinuation of travoprost, pigmentation of the iris is likely to be permanent. The long-term effect…

🤒 Adverse Reactions ~1 min read

6 ADVERSE REACTIONS The following adverse reactions are described elsewhere in the labeling: Ocular or periocular infections [see Contraindications ( 4.1 )] Corneal endothelial dystrophy [see Contraindications ( 4.2 )] Prior corneal transplantation [see Contraindications ( 4.3 )] Hypersensitivity [see Contraindications ( 4.4 )] Device dislocation [see Warnings and Precautions ( 5.2 )] Macular edema [see Warnings and Precautions ( 5.6 )] Intraocular inflammation [see Warnings and Precautions ( 5.7 )] Pigmentation [see Warnings and Precautions ( 5.8 )] Endophthalmitis [see Warnings and Precautions ( 5.9 )] In controlled studies, the most common ocular adverse reactions reported in 2% to 6% of patients were increases in intraocular pressure, iritis, dry eye, and visual field defects ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Glaukos Corporation at 1-888-404-1644 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 following adverse events rates are derived from three randomized, double-masked clinical trials in which 868 patients with open angle glaucoma (OAG) or ocular hypertension (OHT) received an iDose TR and were followed for one year.

The most commonly reported ocular adverse reactions (2% to 6%) were increases in intraocular pressure, iritis, dry eye, visual field defects, eye pain, ocular hyperaemia, and reduced visual acuity. Ocular adverse reactions reported in less than 2% of patients were conjunctival hemorrhage, photophobia, punctate keratitis, blepharitis, eye irritation, corneal abrasion, device dislocation, vitreous detachment, and foreign body sensation in eyes.

👥 Use in Specific Populations ~2 min read

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary There are no adequate and well-controlled studies of iDose TR (travoprost intracameral implant) administration in pregnant women to inform a drug-associated risk. Subcutaneous administration of travoprost to pregnant mice and rats throughout the period of organogenesis produced embryo-fetal lethality, spontaneous abortion, and premature delivery at potentially clinically relevant doses. Advise pregnant women of a potential risk to a fetus. iDose TR should be administered during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Data Animal Data An embryo-fetal development study was conducted in pregnant rats administered travoprost once daily at doses up to 10 mcg/kg by subcutaneous injection from gestation day (GD) 6 to 17, to target the period of organogenesis. At 10 mcg/kg, 116 times the maximum human ocular dose (MHOD) of 1 implant per eye, based on body surface area (BSA), assuming sustained travoprost release from the implant for 6 months or 0.0139 mcg/kg/day, travoprost was teratogenic in rats, evidenced by an increase in the incidence of skeletal malformations as well as external and visceral malformations, including fused sternebrae, domed head and hydrocephaly.

Travoprost caused post-implantation loss at 10 mcg/kg. The fetal no observed adverse effect level (NOAEL) was 3 mcg/kg (34.5 times the maximum human ocular dose (MHOD) of 1 implant per eye, based on BSA). An embryo-fetal development study was conducted in pregnant mice administered travoprost once daily by subcutaneous injection at doses up to 1 mcg/kg from GD 6 to 16, to target the period of organogenesis.

Travoprost induced an increase in post-implantation losses and a decrease in fetal viability in mice at subcutaneous doses > 0.3 mcg/kg. The fetal NOAEL was 0.3 mcg/kg (1.7 times the MHOD based on BSA). The maternal NOAEL was 1 mcg/kg (5.8 times the MHOD based on BSA).

Pre/postnatal development studies were conducted in rats administered travoprost once daily by subcutaneous injection from GD 7 (early embryonic period) to postnatal Day 21 (end of lactation period). At doses of greater than or equal to 0.12 mcg/kg/day (1.4 times the MHOD based on BSA), the incidence of post-natal mortality was increased, and neonatal body weight was decreased. Neonatal development was also affected, evidenced by delayed eye opening, pinna detachment and preputial separation, and by decreased motor activity.

8.2Lactation Risk Summary There are no data on the effects of travoprost on the breastfed child or milk production. It is not known if travoprost is present in human milk following ophthalmic administration. The developmental and health benefits of breastfeeding should be considered, along with the mother's clinical need for iDose TR and any potential adverse effects on the breast-fed child from iDose TR.

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

8.5Geriatric Use No overall differences in safety or effectiveness have been observed between elderly and other adult patients.

🤰 Pregnancy ~2 min read

8.1Pregnancy Risk Summary There are no adequate and well-controlled studies of iDose TR (travoprost intracameral implant) administration in pregnant women to inform a drug-associated risk. Subcutaneous administration of travoprost to pregnant mice and rats throughout the period of organogenesis produced embryo-fetal lethality, spontaneous abortion, and premature delivery at potentially clinically relevant doses. Advise pregnant women of a potential risk to a fetus. iDose TR should be administered during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Data Animal Data An embryo-fetal development study was conducted in pregnant rats administered travoprost once daily at doses up to 10 mcg/kg by subcutaneous injection from gestation day (GD) 6 to 17, to target the period of organogenesis. At 10 mcg/kg, 116 times the maximum human ocular dose (MHOD) of 1 implant per eye, based on body surface area (BSA), assuming sustained travoprost release from the implant for 6 months or 0.0139 mcg/kg/day, travoprost was teratogenic in rats, evidenced by an increase in the incidence of skeletal malformations as well as external and visceral malformations, including fused sternebrae, domed head and hydrocephaly.

Travoprost caused post-implantation loss at 10 mcg/kg. The fetal no observed adverse effect level (NOAEL) was 3 mcg/kg (34.5 times the maximum human ocular dose (MHOD) of 1 implant per eye, based on BSA). An embryo-fetal development study was conducted in pregnant mice administered travoprost once daily by subcutaneous injection at doses up to 1 mcg/kg from GD 6 to 16, to target the period of organogenesis.

Travoprost induced an increase in post-implantation losses and a decrease in fetal viability in mice at subcutaneous doses > 0.3 mcg/kg. The fetal NOAEL was 0.3 mcg/kg (1.7 times the MHOD based on BSA). The maternal NOAEL was 1 mcg/kg (5.8 times the MHOD based on BSA).

Pre/postnatal development studies were conducted in rats administered travoprost once daily by subcutaneous injection from GD 7 (early embryonic period) to postnatal Day 21 (end of lactation period). At doses of greater than or equal to 0.12 mcg/kg/day (1.4 times the MHOD based on BSA), the incidence of post-natal mortality was increased, and neonatal body weight was decreased. Neonatal development was also affected, evidenced by delayed eye opening, pinna detachment and preputial separation, and by decreased motor activity.

🧒 Pediatric Use 17 words

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

🧓 Geriatric Use 19 words

8.5Geriatric Use No overall differences in safety or effectiveness have been observed between elderly and other adult patients.

🧬 Clinical Pharmacology 162 words

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Travoprost free acid, a prostaglandin analog is a selective FP prostanoid receptor agonist, which is believed to reduce IOP by increasing uveoscleral outflow. The exact mechanism of action is unknown at this time.

12.3Pharmacokinetics Travoprost, an isopropyl ester prodrug, is hydrolyzed by esterases in the cornea and other intraocular tissues to its biologically active free acid. Systemically, travoprost free acid is metabolized to inactive metabolites via beta-oxidation of the α (carboxylic acid) chain to give the 1,2-dinor and 1,2,3,4-tetranor analogs, via oxidation of the 15-hydroxyl moiety, as well as via reduction of the 13, 14 double bond. Data from a pharmacokinetic study of 105 subjects evaluating two models of the travoprost intracameral implant with different elution rates have shown that the plasma concentrations of travoprost free acid are below 10 pg/mL (the quantitation limit of the assay, LLOQ) in all subjects at day 10, week 12 and month 12 following administration of iDose TR.

🧬 Mechanism of Action 37 words

12.1Mechanism of Action Travoprost free acid, a prostaglandin analog is a selective FP prostanoid receptor agonist, which is believed to reduce IOP by increasing uveoscleral outflow. The exact mechanism of action is unknown at this time.

📦 How Supplied / Storage and Handling 96 words

16 HOW SUPPLIED/STORAGE AND HANDLING iDose TR (travoprost intracameral implant) (NDC 25357-100-01) is provided sterile and pre-loaded in a sterile, single-dose inserter that is packaged in a blister tray sealed with a Tyvek lid. Implants are individually serialized and the serial number is provided on the tray lid. The tray is sealed inside of a transparent plastic pouch along with an oxygen scavenger packet, which is packaged inside a unit carton.

Tamper evidence is provided by a seal on both ends of the carton. Storage: Store at 2°C to 25°C (36°F to 77°F). Do not freeze.

📋 Description 129 words

11 DESCRIPTION iDose TR (travoprost intracameral implant) is a sterile intracameral implant containing 75 mcg of travoprost. The intracameral implant consists of a titanium implant reservoir with a membrane controlling the sustained release of travoprost. The sterile implant is pre-loaded in a sterile single-dose inserter to facilitate insertion directly through the trabecular meshwork of the anterior chamber angle into the sclera.

Travoprost is a prostaglandin analog. Its chemical name is 5-heptenoic acid, 7-[(1R,2R,3R,5S)-3,5-dihydroxy-2-[(1E,3R)-3-hydroxy-4-[3-(trifluoromethyl)phenoxy]-1-buten-1-yl]cyclopentyl]-, 1-methylethyl ester, (5Z)-. Travoprost has a molecular formula of C 26 H 35 F 3 O 6 and a molecular weight of 500.55 g/mol.

The chemical structure of travoprost is: Travoprost is a clear, colorless to slightly yellow oil that is very soluble in acetonitrile, methanol, octanol, and chloroform. It is practically insoluble in water. Figure-07

💬 Information for Patients ~1 min read

17 PATIENT COUNSELING INFORMATION Intraocular Inflammation or Endophthalmitis Advise patients about the potential risk for complications including, but not limited to, the development of intraocular inflammation or endophthalmitis [see Warnings and Precautions ( 5.6 , 5.7 , 5.9 )]. Potential for Pigmentation Advise patients about the potential for increased brown pigmentation of the iris, which may be permanent [see Warnings and Precautions ( 5.8 )]. MR Conditional Advise patients that the implant is MR Conditional (as noted on their Patient ID card), and that if they require magnetic resonance imaging (MRI), they should inform their healthcare provider that they have iDose TR implanted in their eye [see Warnings and Precautions ( 5.10 )].

When to Seek Physician Advice Advise patients that if the eye becomes red, sensitive to light, painful, or develops a change in vision, they should seek immediate care from an ophthalmologist [see Warnings and Precautions ( 5.2 , 5.7 , 5.9 )] . Symbols that are included in the labeling of this product. Symbol Definition Catalogue/Model Number Serial Number Lot Number Do not re-use Use-by date (year-month) Do not resterilize See package insert for Full Prescribing Information Temperature limit Sterilized by e-beam irradiation For prescription use only Do not use if package is damaged MR Conditional Manufactured by Glaukos Corp., 229 Avenida Fabricante, San Clemente, CA 92672 © 2026 Glaukos.

All rights reserved. Glaukos and iDose are registered trademarks of Glaukos Corporation. All other trademarks are the property of their respective owners.

Patents www.glaukos.com/patents P-000992 Rev 2 symbol0 symbol1 symbol2 symbo13 symbo14 symbol5 symbol6 symbol7 symbol8 symbol9 symbol10 symbol11

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