US FDA approves Glaukos’ new eye therapy
The U.S. Food and Drug Administration has approved a new eye therapy from Glaukos Corp, giving patients a less painful option to treat a progressive condition that can severely affect vision, the company said on Monday.
Shares of the company were up 2.6% in premarket trading.
The approval makes the therapy, called Epioxa, the first FDA-cleared treatment that does not require removal of the eye’s outer protective layer, known as the corneal epithelium.
Epioxa was approved to treat keratoconus, a condition in which the cornea thins and changes shape over time, making vision blurry and increasing the risk of blindness.
Glaukos said it expects Epioxa to be commercially available in the first quarter of 2026.
The company’s first-generation iLink therapy Photrexa, approved in 2016, until now was the only FDA-cleared treatment shown to stop progression of the disease. But, it uses an epi‑off approach where a physician removes the outermost layer of the cornea, increasing the risk of pain and infection, as well as recovery time.
Epioxa was designed to address the issues associated with epi-off by using a novel riboflavin formulation and enhanced UV-A light delivery.
Glaukos already has “a pretty robust install base of systems” from its earlier epi-off therapy, which should help accelerate adoption, BTIG analyst Ryan Zimmerman said.
“It’s not just going to be commercializing existing customers. I think it’s going to bring in new doctors.” he added.
Keratoconus affects about one in 2,000 people, and typically begins in puberty and then progresses into the mid-30s, according to Johns Hopkins Medicine.
Standard care includes eyeglasses, rigid contact lenses, and corneal cross-linking.
The company’s application was based on two late-stage trials, where the therapy showed improvement in the shape of the cornea, a key sign of whether the disease is getting worse, when compared to placebo.
