The US Food and Drug Administration (FDA) has approved Glaukos Corporation’s Epioxa, offering patients living with a rare corneal disease a treatment option that does not require incisions.

Epioxa, which contains an active component from a bio-activated formulation of riboflavin, will be available to patients with keratoconus, an eye condition in which the cornea becomes gradually thinner, ultimately leading to vision loss. Glaukos intends for the therapy to be commercially available in Q1 2026. 

Shares in the NYSE-listed company opened 1.8% up to $88.80 at market open on 20 October following the announcement. Glaukos has a market cap of $5bn.

Around 20% of untreated keratoconus patients require corneal transplants, according to Glaukos. While conventional keratoconus treatments such as eyeglasses or contact lenses address visual symptoms only and do not slow or halt underlying disease progression, according to the company.

Cross-linking procedures are an effective option to stop the progression of the disease, although this approach involves surgical incisions to remove the surface layer of the corneal epithelium. Glaukos’ first-generation corneal cross-linking therapy, known as Photrexa Viscous/Photrexa, received FDA approval in 2016 and has been a main product used for cross-linking therapy. However, Photrexa Viscous/Photrexa requires removal of the epithelium.

Epioxa, meanwhile, does not require this step. Glaukos’ therapy is based on two formulations, Epioxa HD and Epioxa, that are sequentially administered during the cross-linking procedure followed by ultraviolet (UV) activation in an oxygen-enriched environment.

“Epioxa is designed to significantly improve patient comfort and minimise recovery time, representing a game-changing new treatment for patients suffering from keratoconus,” said the company’s CEO Thomas Burns.

“The pain and extended healing time associated with the current surgical procedure are major barriers to adoption,” said Dr W. Barry Lee, president of the Cornea Society. 

The FDA approval was based on data from two randomised Phase III trials (NCT03442751 and NCT05759559). The studies, which enrolled over 400 patients, achieved their primary efficacy endpoints in maximum corneal curvature improvement at 12 months.