Glaukos Submits NDA for Epioxa, a Next-Generation Corneal Cross-Linking Therapy

Glaukos Corporation has officially submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its innovative corneal cross-linking therapy, Epioxa (Epi-on). This next-generation treatment is designed for patients with keratoconus and represents a significant advancement in noninvasive therapies.

A Milestone for Keratoconus Treatment

According to Thomas Burns, Glaukos chairman and CEO:

“The NDA submission for Epioxa represents an important milestone for our company as it brings us one step closer to providing keratoconus patients and the ophthalmic community with the first FDA-approved, noninvasive corneal cross-linking drug therapy that does not require removal of the corneal epithelium, the outermost layer of the front of the eye.”

Burns emphasized that Epioxa is designed to reduce procedure times, enhance patient comfort, and accelerate recovery—factors that could significantly transform the treatment paradigm for keratoconus patients.

NDA Backed by Strong Clinical Evidence

The NDA submission is supported by data from two phase 3 pivotal trials that achieved the prespecified primary efficacy endpoints and demonstrated favorable tolerability and safety profiles.

How Epioxa Works

Epioxa incorporates:

       • Proprietary drug formulation to penetrate the corneal epithelium.

       • Stronger UV-A irradiation protocol to enhance cross-linking efficacy.

       • Supplemental oxygen to improve treatment outcomes.

If approved, Epioxa would be the first FDA-approved, noninvasive corneal cross-linking therapy that preserves the corneal epithelium, offering an alternative to traditional treatments that require epithelial removal.

Glaukos’ Commitment to Keratoconus Care

Glaukos’ iLink therapies, including the first-generation Photrexa (Epi-off), are designed to strengthen corneal tissue and halt the progression of keratoconus, a condition affecting approximately 90% of patients bilaterally.

The Need for Advanced Therapies

       • Keratoconus Overview: A progressive eye disease where the cornea thins and bulges into a cone-like shape.

       • Current Challenges: As many as 20% of patients with advanced keratoconus require corneal transplants, while conventional options like eyeglasses or contact lenses only address symptoms.

       • iLink Success: Photrexa (Epi-off) remains the only FDA-approved therapy proven to slow or halt keratoconus progression, with over 300 peer-reviewed publications supporting its safety and efficacy.

Looking Ahead

Glaukos is optimistic about the FDA's review of Epioxa and its potential to revolutionize keratoconus treatment by combining enhanced efficacy with improved patient experience. This noninvasive therapy is poised to provide patients with a safer, more comfortable alternative that reduces recovery time and procedure duration.

This NDA submission marks a critical step toward redefining care for keratoconus patients and further solidifies Glaukos' leadership in corneal cross-linking innovation.