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Reimagine interventional keratoconus treatment with Epioxa

The first and only FDA-approved epithelium-on oxygen-enriched corneal cross-linking therapy1

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Epioxa allows for interventional KC treatment without waiting for confirmation of progression1

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Most ocular and non-ocular treatment-related adverse events were mild and transient in the 2 trials1,2

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Successfully met endpoint with significantly improved Kmax vs sham procedure/vehicle control1*

  • The treatment effect was nearly double in young patients aged 13-28
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Designed for improved patient comfort and fast recovery1

  • Patients were able to get their second Epioxa treatment as soon as 1 week later

*Epioxa treatment safety and efficacy were studied in 2 prospective, multicenter, randomized sham procedure/vehicle control trials1:
Study 1 design: 279 eyes in participants aged between 13 and 53 years were randomized in 2:1 ratio into CXL with Epioxa and sham procedure/vehicle control arms. The primary efficacy endpoint was changed from baseline in maximum corneal curvature (Kmax) ≥1.0 D at Month 6 (P<.05). Sham procedure/vehicle control eyes could cross over and receive CXL with Epioxa at Month 6 and were followed to Month 12. 19% of eyes (54) had KC severity grade moderate or severe. All participants showed topographic and clinical evidence of KC.1,2
Study 2 design: 312 eyes in participants aged between 13 and 51 years were randomized in 2:1 ratio into CXL with Epioxa and sham procedure/vehicle control arms. The primary efficacy endpoint was the change from baseline in Kmax of ≥1.0 D at Month 12 (P<.05). 22% of eyes (70) were aged ≥30 years and 14% of eyes (45) had KC severity grade moderate or severe. All participants showed topographic and clinical evidence of KC.1-3

CXL=cross-linking; D=diopter; FDA=Food and Drug Administration; KC=keratoconus; Kmax=maximum corneal curvature.

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†Epioxa Copay Program is available for commercially insured eligible patients only. Additional restrictions may apply. Subject to change; click for full terms and conditions from EpioxaCareConnect.

References:

  1. Epioxa HD and Epioxa Prescribing Information. Glaukos Corporation; 2025.
  2. Data on file.
  3. Smith VL, et al. Poster presented at Association for Vision and Ophthalmology; May 4-8, 2025; Salt Lake City, UT.

IMPORTANT SAFETY INFORMATION

The most common side effects were red eye, haze, sensitivity to light, disruption of surface cells of the cornea, eye pain, eye irritation, watery eyes, swelling of eyelid, fine white lines in the cornea, reduced sharpness of vision, dry eye, and eye inflammation.

You should not have the EPIOXA® corneal collagen cross-linking procedure if you have a known hypersensitivity to any ingredients in the product, have had cataract surgery and either did not receive an artificial lens in your eye or received a non-UV blocking artificial lens, have a history of herpetic keratitis, or are pregnant.

If you have any additional questions, please contact your doctor. Please see full Prescribing Information for EPIOXA HD and EPIOXA.

You are encouraged to report all side effects to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088. You may also call Glaukos at 1-888-404-1644.

APPROVED USES

The EPIOXA corneal collagen cross-linking procedure is performed by your eye doctor for the treatment of keratoconus. It does not require the removal of the corneal epithelium (outermost layer of the front of the eye). It consists of EPIOXA® HD (riboflavin 5′-phosphate ophthalmic solution) 0.239% and EPIOXA® (riboflavin 5′-phosphate ophthalmic solution) 0.177%, which are prescription eye drops used in combination with the O2n® System and Boost Goggles®.

The EPIOXA corneal collagen cross-linking procedure is for the treatment of keratoconus in adults and pediatric patients 13 years of age and older.