Glaukos Announces FDA Acceptance of NDA Submission for Epioxa

Glaukos has received notification from the U.S. Food and Drug Administration (FDA) confirming acceptance of its New Drug Application (NDA) for Epioxa (Epi-on), the company’s next-generation corneal cross-linking iLink therapy for the treatment of keratoconus. The FDA has determined that the NDA submission is sufficiently complete to proceed with a substantive review, with a Prescription Drug User Fee Act (PDUFA) target date of October 20, 2025 for a final decision.

A Potentially Transformative Therapy for Keratoconus

Epioxa is designed to offer a noninvasive corneal cross-linking therapy that does not require removal of the corneal epithelium, addressing a key limitation of existing treatment options.

Thomas Burns, Chairman and CEO of Glaukos, highlighted the significance of this development:

“The acceptance of the Epioxa NDA represents another important step in being able to provide 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. We look forward to working closely with the FDA throughout their review process and continue to believe Epioxa, which is designed to reduce procedure times, improve patient comfort, and shorten recovery time, represents a potentially meaningful advancement in the treatment paradigm for patients suffering from keratoconus.”

Clinical Data Supporting Epioxa’s NDA Submission

Glaukos’ NDA submission includes findings from two Phase 3 pivotal trials, both of which:

       • Successfully achieved the prespecified primary efficacy endpoints

       • Demonstrated a favorable safety and tolerability profile

These results reinforce the potential benefits of Epioxa as a less invasive alternative to current corneal cross-linking treatments.

Epioxa’s Advantages Over Traditional Keratoconus Treatments

Glaukos’ corneal cross-linking iLink therapies utilize proprietary, bio-activated drug formulations designed to strengthen corneal tissue and halt keratoconus progression.

       • Keratoconus affects approximately 90% of cases bilaterally, and up to 20% of patients may ultimately require a corneal transplant.

       • Current treatment options such as eyeglasses or contact lenses primarily manage symptoms but do not address disease progression.

       • Glaukos’ first-generation iLink therapy (Photrexa, or Epi-off) is the first and only FDA-approved therapy proven to slow or halt keratoconus progression.

There are more than 300 peer-reviewed publications supporting the safety and performance of Glaukos’ iLink therapy.

Epioxa’s Novel Approach to Corneal Cross-Linking

Epioxa introduces a proprietary drug formulation that allows for effective penetration of the corneal epithelial layer, combined with:

       • A stronger UV-A irradiation protocol

       • The use of supplemental oxygen to enhance cross-linking

If approved, Epioxa would be the first FDA-approved, noninvasive corneal cross-linking therapy that does not require epithelium removal, offering a potentially more comfortable and efficient treatment for patients with keratoconus.

As the FDA review progresses, Epioxa represents a significant step forward in advancing the standard of care for keratoconus management.