FDA approves Glaukos’ Epioxa as incision-free corneal illness therapy
The US Meals and Drug Administration (FDA) has authorized Glaukos Company’s Epioxa, providing sufferers residing with a uncommon corneal illness a therapy choice that doesn’t require incisions.
Epioxa, which comprises an energetic element from a bio-activated formulation of riboflavin, might be out there to sufferers with keratoconus, an eye fixed situation through which the cornea turns into regularly thinner, in the end resulting in imaginative and prescient loss. Glaukos intends for the remedy to be commercially out there in Q1 2026.
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Shares within the NYSE-listed firm opened 1.8% as much as $88.80 at market open on 20 October following the announcement. Glaukos has a market cap of $5bn.
Round 20% of untreated keratoconus sufferers require corneal transplants, in line with Glaukos. Whereas standard keratoconus therapies corresponding to eyeglasses or contact lenses tackle visible signs solely and don’t sluggish or halt underlying illness development, in line with the corporate.
Cross-linking procedures are an efficient choice to cease the development of the illness, though this method entails surgical incisions to take away the floor layer of the corneal epithelium. Glaukos’ first-generation corneal cross-linking remedy, often known as Photrexa Viscous/Photrexa, acquired FDA approval in 2016 and has been a essential product used for cross-linking remedy. Nonetheless, Photrexa Viscous/Photrexa requires removing of the epithelium.
Epioxa, in the meantime, doesn’t require this step. Glaukos’ remedy relies on two formulations, Epioxa HD and Epioxa, which might be sequentially administered through the cross-linking process adopted by ultraviolet (UV) activation in an oxygen-enriched setting.
“Epioxa is designed to considerably enhance affected person consolation and minimise restoration time, representing a game-changing new therapy for sufferers affected by keratoconus,” stated the corporate’s CEO Thomas Burns.
“The ache and prolonged therapeutic time related to the present surgical process are main boundaries to adoption,” stated Dr W. Barry Lee, president of the Cornea Society.
The FDA approval was primarily based on knowledge from two randomised Part III trials (NCT03442751 and NCT05759559). The research, which enrolled over 400 sufferers, achieved their major efficacy endpoints in most corneal curvature enchancment at 12 months.
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