Glaukos Corporation, an ophthalmic pharmaceutical and medical technology company focused on novel therapies for the treatment of glaucoma, corneal disorders and retinal diseases, announced it has received the “Day 74” notification from the FDA acknowledging the previously submitted New Drug Application (NDA) for Epioxa (Epi-on), its next-generation corneal cross-linking iLink therapy for the treatment of keratoconus, a sight-threatening corneal disease, is sufficiently complete to permit a substantive review.
The Prescription Drug User Fee Act (PDUFA) goal date for the completion of the FDA’s review of the Epioxa NDA is set for Oct. 20, 2025. This date reflects a standard 10-month review period, which is consistent with the company’s expectations.
“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 CEO. “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.”
The NDA submission includes data from two phase 3 pivotal trials of Epioxa, which both successfully achieved the pre-specified primary efficacy endpoints and demonstrated favorable tolerability and safety profiles.
Glaukos’ corneal cross-linking iLink therapies use proprietary, bio-activated drug formulations designed to strengthen corneal tissue and halt progression of keratoconus. Typically diagnosed in a patient’s teenage years, keratoconus is a debilitating eye condition characterized by progressive thinning and weakening of the cornea.
If left untreated, keratoconus can lead to loss of vision and even blindness and is one of the leading causes of corneal transplant (penetrating keratoplasty) in the United States.
Approximately 90% of cases of keratoconus are bilateral and as many as 20% of patients ultimately require a corneal transplant. Conventional keratoconus treatments such as eyeglasses or contact lenses address symptoms but Glaukos’ first-generation iLink therapy, known as Photrexa, or Epi-off, is the first and only FDA-approved therapy that has been shown to slow or halt disease progression.
There are more than 300 peer-reviewed publications supporting the performance and safety of Glaukos’ iLink therapy.
Epioxa utilizes a proprietary, novel drug formulation designed to penetrate the epithelial layer of the cornea, a stronger UV-A irradiation protocol and supplemental oxygen to enhance cross-linking.
If approved, the company anticipates Epioxa would be the first FDA-approved, non-invasive corneal cross-linking therapy that does not require removal of the corneal epithelium, the outermost layer of the front of the eye.