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EPIOXA CROSS-LINKING riboflavin 5-phosphate ophthalmic Kit — NDC 25357-0024-01 package photo

EPIOXA CROSS-LINKING riboflavin 5-phosphate ophthalmic Kit

by Glaukos Corporation · 1 KIT in 1 CARTON (25357-024-01) * 1 SYRINGE, GLASS in 1 POUCH (25357-026-01) / 2 mL in 1 SYRINGE, GLASS * 1 SYRINGE, GLASS in 1 POUCH (25357-027-01) / 2 mL in 1 SYRINGE, GLASS
NDC 25357-0024-01
🏷️ FDA NDC (as labeled) 25357-024-01 billing pads the product segment with a zero
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 →

This page is curated, coded, and maintained by

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

🆔 Identity & classification

FDA NDC (as labeled) 25357-024-01
Product NDC 25357-024
11-digit billing NDC 25357002401
NCPDP billing unit EA — each (per item)
RxCUI 2727363, 2727368, 2727371, 2727373, 2727374, 2727375
Application # NDA219910
SPL Set ID 13cefc46-337c-41a3-b113-106bfe553bbb
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-01-16
Route OPHTHALMIC
Dosage form KIT
GCN Seq No 088367
GCN 58493
HICL code 001072
Ingredient (HICL) Riboflavin 5-Phosphate Sod(B2)
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 Q2P
Therapeutic class — specific (HIC3) Agents For Corneal Collagen Cross-Linking
AHFS code 52:92.00.00
AHFS class Eent Drugs, Miscellaneous
FDB label name EPIOXA CROSS-LINKING KIT
FDB brand name Epioxa
Legend status F — Federal legend — prescription drug or device
Why two NDCs? The FDA registers this code as 25357-024-01 — 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 → 25357-0024-01. 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.

🏷️ RxNorm drug class

This medicine belongs to the Photoenhancer class.

Pharmacologic class Photoenhancer
How it works Photoabsorption
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 applicationNDA219910 (NDA)
Labeler code25357
First marketedJan 2026
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 EPIOXA CROSS-LINKING KIT Ingredient Riboflavin 5-Phosphate Sod(B2)
📖 What it is MedlinePlus · NLM

Riboflavin 5'-phosphate ophthalmic is used as part of a corneal cross-linking procedure (an eye procedure that uses UV light) to treat keratoconus (an eye condition in which the cornea thins and changes shape causing blurred vision and other vision changes). Riboflavin 5'-phosphate is a type of vitamin B. It works as a photoenhancer that is activated by UV light to help form bonds to strengthen the cornea.

Read the full MedlinePlus article ↗

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.

🧪 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.
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
Epioxa Cross-Linkingthis 25357-0024-01 Glaukos 1 kit — — 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

🏛️
2025
First FDA approval
Oct 2025
📍
2026
Currently FDA-listed
1 year listed
🛡️
2028
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 Oct 2028. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Oct 17, 2025 RLD RS ⏳ ~2.1 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
Exclusivity NP
2025 2027
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.

FDA exclusivity
CodeWhat it grantsExpires
NPNew ProductOct 17, 2028
Common questions
Is there a generic version of EPIOXA CROSS-LINKING KIT?
No FDA-approved generic equivalent is currently listed in the FDA Orange Book for EPIOXA CROSS-LINKING KIT. Based on the patents and exclusivity currently listed, the Orange Book estimate is that full-label generic entry may be delayed until Oct 2028 — 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.

🔬 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 EPIOXA CROSS-LINKING (this brand).

Top reported reactions

Corneal Epithelium Defect4
Foreign Body Sensation In Eyes1

Reporter sex

4 reports
Female · 100%
Reports over time (by year) — tap or hover for the count & year
2025 2026 4 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
25357-0024-01 You're viewing this 1 KIT in 1 CARTON (25357-024-01) * 1 SYRINGE, GLASS in 1 POUCH (25357-026-01) / 2 mL in 1 SYRINGE, GLASS * 1 SYRINGE, GLASS in 1 POUCH (25357-027-01) / 2 mL in 1 SYRINGE, GLASS 2026-01-16 Active

🧭 About this NDC listing & data coverage

Finished prescription product Kit / multi-component package

Kit / multi-component package

This NDC identifies a kit — a package containing more than one component. Structured data (pricing, ingredients, equivalents) is often reported per component rather than for the kit NDC itself, which can make this page look thinner than the components' own pages.

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 25357-024-01, 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: 25357-0024-01, written without dashes as 25357002401. 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 25357-0024-01, the first segment (25357) is the labeler code FDA assigned to Glaukos Corporation; the middle segment (0024) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) 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.
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 ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients
🎯 Indications and Usage 86 words ▾

1 INDICATIONS AND USAGE EPIOXA HD and EPIOXA are indicated in epithelium-on corneal collagen cross-linking for the treatment of keratoconus in adults and pediatric patients aged 13 years and older, in conjunction with the O 2 n System and the Boost Goggles. EPIOXA HD and EPIOXA are photoenhancers indicated for use in epithelium-on corneal collagen cross-linking for the treatment of keratoconus in adults and pediatric patients aged 13 years and older, in conjunction with the O 2 n System and the Boost Goggles ( 1 ).

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Apply topical anesthetic and insert a lid speculum ( 2 ). Using a cellulose spear sponge soaked with EPIOXA HD, remove the mucin layer from the corneal surface without debriding the corneal epithelium (epithelium-on) by swiping the sponge 4 to 10 times horizontally and vertically ( 2 ). Apply two drops of EPIOXA HD topically on the eye every 60 seconds for 4 minutes (STEP 1), followed by two drops of EPIOXA topically on the eye every 30 seconds for 6 minutes (STEP 2) ( 2 ).

Gently rinse the corneal surface with approximately 5 mL of balanced salt solution (BSS) ( 2 ). Perform ultrasound pachymetry. If corneal thickness is less than 325 microns, irradiation should not be performed ( 2 ).

Apply the Boost Goggles and turn on the oxygen flow. Refer to the Boost Goggles User Guide ( 2 ). Center the optical head of the O 2 n System over the cornea and irradiate the eye as per the instructions in the O 2 n System Operator's Manual .

The O 2 n System automatically delivers irradiation to the eye for 11 minutes 6 seconds at 30 mW/cm 2 with an on/off cycle of 1 second UV-A on/ 1 second UV-A off at a wavelength of 365 nm ( 2 ). Instill BSS on the cornea every 2 minutes, or more frequently as needed, to maintain corneal hydration during UV-A irradiation ( 2 ). When the UV-A irradiation has stopped, shut off the oxygen flow and remove the Boost Goggles and lid speculum ( 2 ).

Apply a bandage contact lens ( 2 ).

2.1Important Administration Instructions EPIOXA HD and EPIOXA are for topical ophthalmic use. NOT for injection or intraocular use. EPIOXA HD and EPIOXA are supplied in single-dose syringes. Discard opened syringes after use. EPIOXA HD and EPIOXA are for use with the O 2 n System and Boost Goggles only. Refer to the O 2 n System Operator's Manual and Boost Goggles User Guide for device instructions.

2.2Recommended Dosage and Administration Instructions Apply topical anesthetic and insert a lid speculum. Using a cellulose spear sponge soaked with EPIOXA HD, remove the mucin layer from the corneal surface without debriding the corneal epithelium (epithelium-on) by swiping the sponge 4 to 10 times horizontally and vertically. Apply two drops of EPIOXA HD topically on the eye every 60 seconds for 4 minutes (STEP 1), followed by two drops of EPIOXA topically on the eye every 30 seconds for 6 minutes (STEP 2).

Gently rinse the corneal surface with approximately 5 mL of balanced salt solution (BSS). Perform ultrasound pachymetry. If corneal thickness is less than 325 microns, irradiation should not be performed.

Apply the Boost Goggles and turn on the oxygen flow as per the instructions in the Boost Goggles User Guide . Center the optical head of the O 2 n System over the cornea and irradiate the eye as per the instructions in the O 2 n System Operator's Manual . The O 2 n System automatically delivers irradiation to the eye for 11 minutes 6 seconds at 30 mW/cm 2 with an on/off cycle of 1 second UV-A on/1 second UV-A off at a wavelength of 365 nm.

Instill BSS on the cornea every 2 minutes, or more frequently as needed, to maintain corneal hydration during UV-A irradiation. When the UV-A irradiation has stopped, shut off the oxygen flow, and remove the Boost Goggles and lid speculum. Apply a bandage contact lens.

💊 Dosage Forms and Strengths 71 words ▾

3 DOSAGE FORMS AND STRENGTHS Ophthalmic solution: EPIOXA HD 0.239% in a single-dose glass syringe ( 3.1 ) Ophthalmic solution: EPIOXA 0.177% in a single-dose glass syringe ( 3.2 )

3.1EPIOXA HD Ophthalmic solution: 0.239% (2.39 mg/mL) of riboflavin 5'-phosphate in a clear, yellow, solution in a single-dose glass syringe.

3.2EPIOXA Ophthalmic solution: 0.177% (1.77 mg/mL) of riboflavin 5'-phosphate in a clear, yellow, solution in a single-dose glass syringe.

⛔ Contraindications 64 words ▾

4 CONTRAINDICATIONS Hypersensitivity ( 4.1 ) Aphakic and pseudophakic patients without a UV-blocking intraocular lens ( 4.2 )

4.1Hypersensitivity EPIOXA HD and EPIOXA are contraindicated in patients with known hypersensitivity to benzalkonium chloride or any ingredients in EPIOXA HD and EPIOXA.

4.2Aphakic and Pseudophakic Patients Epithelium-on corneal collagen cross-linking is contraindicated in aphakic patients and pseudophakic patients without a UV-blocking intraocular lens.

⚠️ Warnings and Cautions 55 words ▾

5 WARNINGS AND PRECAUTIONS Herpetic keratitis : Use with caution in patients with a history of herpetic keratitis due to the potential for reactivation ( 5 ).

5.1Herpetic Keratitis Corneal collagen cross-linking should be used with caution in patients with a history of herpetic keratitis due to the potential for reactivation of herpes keratitis.

🤒 Adverse Reactions ~1 min read ▾

6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Herpetic keratitis [see Warnings and Precautions (5.1) ] The most common adverse reaction was conjunctival hyperaemia (31%). Other adverse reactions, occurring in 5% to 25% of eyes included: corneal opacity (haze), photophobia, punctate keratitis, eye pain, eye irritation, increased lacrimation, corneal epithelium defect, eyelid oedema, corneal striae, visual acuity reduced, dry eye, and anterior chamber flare ( 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 safety of EPIOXA HD and EPIOXA in the epithelium-on corneal collagen cross-linking procedure with UV-A irradiation and supplemental oxygen was evaluated in two randomized, parallel-group, sham procedure/vehicle-controlled trials.

Study eyes were randomized in a 2:1 treatment allocation to receive corneal collagen cross-linking (CXL) or sham procedure/vehicle control at the baseline visit. In both trials, CXL-treated eyes were followed for 12 months. Safety data were obtained from a total of 389 CXL-treated eyes.

The most commonly reported adverse reaction in CXL-treated eyes was conjunctival hyperaemia (31%). Other adverse reactions occurring in 5% to 25% of CXL-treated eyes included: corneal opacity (haze), photophobia, punctate keratitis, eye pain, eye irritation, lacrimation increased, corneal epithelium defect, eyelid oedema, corneal striae, visual acuity reduced, dry eye, and anterior chamber flare.

👥 Use in Specific Populations 189 words ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary Animal development and reproduction studies have not been conducted with EPIOXA HD and EPIOXA with the O 2 n System and Boost Goggles. Since it is not known whether the epithelium-on corneal collagen cross-linking procedure can cause fetal harm or affect reproduction capacity, it should not be performed on pregnant women.

8.2Lactation Risk Summary There are no data on the presence of EPIOXA HD or EPIOXA in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered, along with the mother's clinical need for the EPIOXA HD and EPIOXA epithelium-on corneal collagen cross-linking procedure and any potential adverse effects on the breastfed child from the EPIOXA HD and EPIOXA epithelium-on corneal collagen cross-linking procedure or from the underlying maternal condition.

8.4Pediatric Use The safety and effectiveness of EPIOXA HD and EPIOXA for the treatment of keratoconus have been established in pediatric patients aged 13 years and older.

8.5Geriatric Use No patients enrolled in the clinical trials were 65 years of age or older.

🤰 Pregnancy 55 words ▾

8.1Pregnancy Risk Summary Animal development and reproduction studies have not been conducted with EPIOXA HD and EPIOXA with the O 2 n System and Boost Goggles. Since it is not known whether the epithelium-on corneal collagen cross-linking procedure can cause fetal harm or affect reproduction capacity, it should not be performed on pregnant women.

🧒 Pediatric Use 28 words ▾

8.4Pediatric Use The safety and effectiveness of EPIOXA HD and EPIOXA for the treatment of keratoconus have been established in pediatric patients aged 13 years and older.

🧓 Geriatric Use 17 words ▾

8.5Geriatric Use No patients enrolled in the clinical trials were 65 years of age or older.

🧬 Clinical Pharmacology 85 words ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Riboflavin 5'-phosphate sodium (Vitamin B2) is the precursor of two coenzymes, flavin adenine dinucleotide and flavin mononucleotide, which catalyze oxidation/reduction reactions involved in a number of metabolic pathways. Under the conditions used for corneal collagen cross-linking, riboflavin 5'-phosphate functions as a photoenhancer and generates singlet oxygen which is responsible for the cross-linking.

12.2Pharmacodynamics The pharmacodynamics of EPIOXA HD and EPIOXA have not been characterized.

12.3Pharmacokinetics The pharmacokinetics of EPIOXA HD and EPIOXA have not been characterized.

🧬 Mechanism of Action 56 words ▾

12.1Mechanism of Action Riboflavin 5'-phosphate sodium (Vitamin B2) is the precursor of two coenzymes, flavin adenine dinucleotide and flavin mononucleotide, which catalyze oxidation/reduction reactions involved in a number of metabolic pathways. Under the conditions used for corneal collagen cross-linking, riboflavin 5'-phosphate functions as a photoenhancer and generates singlet oxygen which is responsible for the cross-linking.

📦 How Supplied / Storage and Handling 131 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING EPIOXA HD (riboflavin 5'-phosphate ophthalmic solution) 0.239%, and EPIOXA (riboflavin 5'-phosphate ophthalmic solution) 0.177%, are clear, yellow, ophthalmic solutions. EPIOXA HD and EPIOXA are co-packaged in an Epithelium-on Cross-linking Kit (NDC 25357-024-01) containing: One single-dose glass syringe containing 2 mL of EPIOXA HD 0.239% packaged in a foil pouch. One single-dose glass syringe containing 2 mL of EPIOXA 0.177% packaged in a foil pouch.

Store kit refrigerated at 2°C to 8°C (36°F to 46°F). Do not freeze. Minimize exposure of the syringes to light once removed from their protective packaging.

For topical ophthalmic use. Single-dose only. Discard syringes after use.

EPIOXA HD and EPIOXA are for use only with the O 2 n System, the single-use O 2 n System Treatment Activation Card, and Boost Goggles.

📦 Storage and Handling 62 words ▾

Store kit refrigerated at 2°C to 8°C (36°F to 46°F). Do not freeze. Minimize exposure of the syringes to light once removed from their protective packaging. For topical ophthalmic use. Single-dose only. Discard syringes after use. EPIOXA HD and EPIOXA are for use only with the O 2 n System, the single-use O 2 n System Treatment Activation Card, and Boost Goggles.

📋 Description ~1 min read ▾

11 DESCRIPTION EPIOXA HD (riboflavin 5'-phosphate ophthalmic solution) 0.239% and EPIOXA (riboflavin 5'-phosphate ophthalmic solution) 0.177% contain riboflavin 5'-phosphate, a photoenhancer, for topical ophthalmic use. EPIOXA HD 0.239% is a clear, yellow, sterile buffered solution containing 2.39 mg/mL riboflavin 5'-phosphate. The pH of the solution is 6.7 to 7.7 and the osmolality is 200 mOsm/kg to 260 mOsm/kg.

Each mL of solution contains 2.50 mg of riboflavin 5'-phosphate sodium (equivalent to 1.97 mg/mL riboflavin). Riboflavin 5'-phosphate sodium is a mixture of the sodium salts of riboflavin, riboflavin monophosphates, and riboflavin diphosphates. The inactive ingredients are hydroxypropyl methylcellulose, sodium chloride, dibasic sodium phosphate dihydrate, edetate disodium dihydrate, tromethamine, monobasic sodium phosphate dihydrate, benzalkonium chloride, and water for injection.

Sodium hydroxide and/or hydrochloric acid may be added to adjust pH. EPIOXA 0.177% is a clear, yellow, sterile buffered solution containing 1.77 mg/mL riboflavin 5'-phosphate. The pH of the solution is 6.5 to 7.5 and the osmolality is 330 mOsm/kg to 400 mOsm/kg.

Each mL of solution contains 1.85 mg of riboflavin 5'-phosphate sodium (equivalent to 1.46 mg/mL riboflavin). Riboflavin 5'-phosphate sodium is a mixture of the sodium salts of riboflavin, riboflavin monophosphates, and riboflavin diphosphates. The inactive ingredients are sodium chloride, dibasic sodium phosphate dihydrate, tromethamine, monobasic sodium phosphate dihydrate, and water for injection.

Sodium hydroxide and/or hydrochloric acid may be added to adjust pH. The molecular formula for riboflavin 5'-phosphate sodium (Vitamin B2) is C 17 H 20 N 4 NaO 9 P with a molecular weight of 478.33 g/mol. Chemical Structure

💬 Information for Patients 48 words ▾

17 PATIENT COUNSELING INFORMATION Advise patients that there may be discomfort in the treated eye and that sunglasses may help with light sensitivity. Instruct patients that they should contact their physician immediately if they experience severe pain in the treated eye or any sudden decrease in their vision.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 25280-0006-42 · Loesch 25357-0025-03 · Glaukos →
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.