The candidate for FDA approval is an epi-on evolution of their previous iLink procedure.
Glaukos Corporation (California, USA) has announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Epioxa (Epi-on), a non-invasive corneal cross-linking therapy designed to treat keratoconus.
If approved, Epioxa would be the first FDA-sanctioned, non-invasive treatment for keratoconus, a progressive eye disease that weakens and thins the cornea, often leading to severe vision loss or even corneal transplants.
“The NDA submission for Epioxa represents an important milestone for our company as it brings us one step closer 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 statement.
Common non-invasive solutions for the disease, like glasses and contact lenses, manage symptoms but cannot halt disease progression. There are cornea transplantation options that may halt progression, but these procedures are seen as highly invasive. These procedures also notably require donor tissue, of which there is an accelerating global shortage.
Glaukos’ existing FDA-approved iLink corneal cross-linking therapy, which includes Photrexa® (Epi-off), is currently one of the few non-transplantation options available proven to slow or stop keratoconus advancement.
Epioxa is a novel drug formulation and utilizes the iLink procedure, enhanced UV-A irradiation and supplemental oxygen. This leads to a procedure that preserves the corneal epithelium (epi-on)—resulting in potentially greater patient comfort, shorter procedure times and faster recovery.
The NDA submission is supported by data from two pivotal Phase 3 clinical trials, which met their primary efficacy endpoints while demonstrating favorable safety and tolerability.
The road ahead
The FDA’s review of the Epioxa NDA will determine whether this therapy will join Glaukos’ expanding portfolio of advanced ophthalmic solutions. The company recently launched iDose® TR (travoprost intracameral implant), a long-duration glaucoma therapy, and continues to drive innovation in chronic eye disease treatments.
“We look forward to working closely with the FDA in their pending review process and continue to believe Epioxa…respresents a potentially meaningful advancement in the treatment paradigm for patients suffering from keratoconus,” stated Glaukos Chairman and CEO Thomas Burns in a news release.
For now, patients, clinicians, and investors await updates on the FDA’s decision, with hopes that Epioxa will set a new standard in the treatment of keratoconus.
