Industry

Epioxa significantly slows keratoconus progression over 12 months

Healio Optometry22h ago1 min read

Epioxa, an epithelium-on corneal collagen cross-linking therapy, made a significant and clinically meaningful difference in keratoconus progression over 12 months, according to a study published in Ophthalmology and Therapy.The procedure, available in the U.S. since March, was approved by the FDA in 2025. Previously, cross-linking for keratoconus required debridement of the corneal epithelium, which has potential side effects.In a phase 3 randomized controlled trial, Kenneth A. Beckman, MD, FACS, of Comprehensive EyeCare of Central Ohio, and colleagues evaluated the use of Epioxa (riboflavin

Read full article on Healio Optometry

AI Summary

Quick Take

Epioxa, an epithelium-on corneal collagen cross-linking (CXL) therapy, significantly slows keratoconus progression over 12 months according to new Phase 3 data. The treatment, which received FDA approval in 2025, offers a less invasive alternative to traditional CXL by eliminating the need for epithelial debridement.

Why It Matters

The shift from "epi-off" to "epi-on" cross-linking is a major milestone in keratoconus management, as epithelial debridement is the primary source of post-operative pain and infection risk. By proving clinical efficacy over a year-long period, Epioxa validates a more patient-friendly approach that preserves the corneal barrier. This could lower the threshold for intervention, allowing practitioners to treat progressive disease earlier with fewer concerns about recovery morbidity and surgical complications.

Key Findings

Epioxa demonstrated a significant and clinically meaningful difference in slowing keratoconus progression compared to control groups over a 12-month period.
The procedure successfully utilizes an epithelium-on technique, maintaining the corneal surface throughout the riboflavin application.
Data from the Phase 3 randomized controlled trial confirms that the riboflavin formulation effectively penetrates the cornea to facilitate cross-linking without surgical debridement.

Key Details

FDA approved in 2025.
Commercially available in the United States since March.
Study results were published in the journal Ophthalmology and Therapy.
Led by Kenneth A. Beckman, MD, FACS, of Comprehensive EyeCare of Central Ohio.

Study Snapshot

Design

Phase 3 randomized controlled trial

Population

Patients with keratoconus

Practice Implications

Clinicians can now offer a stabilization procedure that avoids the morbidity of epithelial removal, potentially improving the patient experience and reducing chair time for post-operative complication management. This therapy should be considered for patients with progressive keratoconus who may have previously deferred treatment due to the risks or recovery time associated with traditional epi-off CXL.

Who's Affected

Cornea SpecialistsOptometristsRefractive SurgeonsContact Lens Fitters

Evidence StrengthStrong

AI-generated summary — always read the original source for full context

Discussion

No comments yet. Be the first to share your thoughts.