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Biotech Stocks Facing FDA Decision In October 2025

Glaukos
Glaukos

Glaukos Corp. (GKOS) is awaiting an FDA decision for its next-generation corneal cross-linking iLink therapy, Epioxa, proposed for the treatment of keratoconus, expected by October 20, 2025.

Keratoconus, a sight-threatening corneal disease, is typically diagnosed in a patient’s teenage years and is characterized by progressive thinning and weakening of the cornea. If left untreated, keratoconus can lead to loss of vision and even blindness. Around 90% of cases affect both eyes, and up to 20% of patients may eventually need a corneal transplant.

Glaukos’ corneal cross-linking iLink therapies use proprietary, bio-activated drug formulations designed to strengthen corneal tissue and halt the progression of keratoconus. The company’s first-generation iLink therapy, known as Photrexa or Epi-off, is the first and only FDA-approved therapy shown to slow or halt disease progression in keratoconus. However, Photrexa requires the removal of the epithelium, the outermost layer of the cornea, to ensure penetration of the prescription eye drops.

Epioxa, if approved, could be the first FDA-approved, non-invasive corneal cross-linking drug therapy that does not require removal of the corneal epithelium.

GKOS closed Friday’s (September 26, 2025) trading at $79.92, down 1.90%.