Epioxa by Glaukos Corp received US Food and Drug Administration (FDA) approval on 20 October as the first and only incision-free, topical drug therapy for keratoconus, marking a landmark advance in keratoconus treatment. The approval redefines a treatment category long dominated by invasive, procedure-based solutions, transforming keratoconus care into a pharmacologic model centred on patient comfort and accessibility.
Keratoconus is a rare, progressive corneal disorder affecting over 300,000 people in the US, though precise prevalence data remains limited due to underdiagnosis. Given the rarity of the condition and the historically procedural nature of treatment, many patients have faced limited options – especially those deterred by the invasiveness of cross-linking surgery or living in underserved regions with limited access to specialised ophthalmic care.
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Developed by Glaukos Corp, Epioxa is a small molecule drug delivered as an eye drop that strengthens the cornea – the clear front surface of the eye – by promoting natural cross-linking of its structural proteins. This reinforcement helps stabilise the cornea and slow disease progression without requiring any cuts or removal of tissue, eliminating the pain, infection risk, and lengthy recovery time associated with traditional surgical approaches.
Until now, Photrexa by Glaukos Corp, approved in 2016, remained the only FDA-cleared therapy proven to halt keratoconus progression. However, Photrexa requires a surgical procedure where the outer layer of the cornea is scraped away before applying riboflavin (a vitamin) and ultraviolet light to strengthen the tissue. While effective, this approach causes significant postoperative pain, carries infection risk, and requires extended recovery time. In comparison, Epioxa’s eye-drop formulation eliminates these procedural barriers, offering a truly noninvasive alternative that may be suitable for more patients and easier to adhere to over time.
Epioxa’s approval represents a pivotal shift towards addressing these unmet needs. This pharmacologic approach not only democratises access but also aligns with the growing emphasis on patient-centred care in rare disease treatment. Commercial launch is anticipated in the first quarter of 2026 in the US, with additional regulatory filings expected in Europe and Japan.
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By GlobalData
