FDA Accepts NDA for Epioxa Eye Therapy

Glaukos Corporation recently received the “Day 74” notification from the FDA, or, in other words, the agency has accepted the ophthalmic pharmaceuticals and medical technology organization’s new drug application (NDA) for Epioxa.

Epioxa is referred as a next-generation corneal cross-linking therapy designed for the treatment of keratoconus, a progressive and sight-threatening eye disease, according to Glaukos.

After receiving the Day 74 letter, which outlines the FDA’s initial assessment of the application, the agency accepted Epioxa for review for efficacy and safety and plans to complete the process by October 20, 2025 under the Prescription Drug User Fee Act (PDUFA).

Keratoconus is a serious eye condition that causes the cornea to thin out and weaken, resulting in one’s vision to gradually worsen. If not treated, some folks may need a corneal transplant.

According to the Cleveland Clinic, keratoconus affects about 50 to 200 people out of every 100,000. It usually begins in the teenage years or early adulthood and gets worse over time, with younger people often seeing faster changes in their vision.

Existing treatments for keratoconus primarily focus on symptom management rather than stopping the disease's progression.

Glaukos’ first-generation iLink therapy (Photrexa), known as Epi-off, is the only FDA-approved treatment that slows or stops keratoconus progression.

Epioxa represents a significant advancement, as it’s a non-invasive therapy that does not require the removal of the corneal epithelium, the outermost layer of the eye.

The clinical trials for Epioxa have shown promising results on patients.

For example, the NDA submission includes data from two Phase 3 pivotal trials, both of which met their primary efficacy endpoints and demonstrated strong safety and tolerability profiles.

One study showed a clinically meaningful and statistically significant improvement in maximum corneal curvature (Kmax) at 12 months compared to a placebo-controlled group.

In addition, 91.5% of patients in the treatment group completed the 12-month study, compared to 90.9% in the control group.

Epioxa uses a proprietary drug formulation designed to penetrate the corneal epithelium more effectively.

It also incorporates a stronger UV-A irradiation protocol and supplemental oxygen to enhance the cross-linking process.

If approved, it would be the first FDA-approved non-invasive corneal cross-linking therapy that does not require epithelial removal.

This therapy could reduce procedure times, improve patient comfort and shorten recovery periods.

Glaukos executives have expressed optimism about Epioxa’s potential to transform keratoconus treatment.

“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, non-invasive corneal cross-linking drug therapy that does not require removal of the corneal epithelium, the outermost layer of the front of the eye,” said Thomas Burns, Glaukos chairman and chief executive officer, in a press release.

“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.”

With over 300 peer-reviewed publications supporting Glaukos’ iLink therapies, the company shared its confidence in the release that Epioxa will build on the success of its first-generation treatment.

The development of Epioxa is expected to expand treatment options for keratoconus patients and potentially reduce the need for corneal transplants in severe cases.

If approved, Epioxa could revolutionize keratoconus treatment by offering a non-invasive, effective alternative to current therapies.