iDose TREX implant
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Glaukos Corporation (GKOS) Advances Next-Gen Glaucoma and Corneal Therapies, Eyes FDA Approval for Epioxa
Yahoo Financeยท 2025-09-18 14:40
Company Overview - Glaukos Corporation (NYSE:GKOS) is a leader in ophthalmic pharmaceutical and surgical therapies, focusing on glaucoma, corneal disorders, and retinal diseases through innovative "dropless" treatment platforms [2] - The company has developed the FDA-approved iDose sustained-release implant, which delivers continuous glaucoma therapy directly inside the eye, enhancing patient adherence and outcomes [2] Financial Performance - In Q2 2025, Glaukos reported a 30% year-over-year increase in net sales, reaching $124.1 million [3] - U.S. glaucoma treatment sales for the quarter amounted to $72.3 million, leading the company to raise its full-year guidance to a range of $480-$486 million [3] - The growth is attributed to strong adoption of the iDose TR implant and increasing market penetration [3] Product Pipeline and Innovations - Glaukos is advancing its pipeline with next-generation therapies, including the iDose TREX implant, which is currently in Phase 2b/3 trials aimed at extending treatment duration and improving compliance [3] - Ongoing trials for iStent Infinite and PRESERFLO devices are expected to broaden the company's long-term growth potential [3] Regulatory Developments - The company's Epioxa, a non-invasive epi-on corneal cross-linking therapy for keratoconus, has received FDA acceptance for review, with a PDUFA date set for October 20, 2025 [4] - If approved, Epioxa would be the first therapy of its kind that does not require corneal epithelium removal, promising shorter recovery times and enhanced patient comfort [4]