Glaukos Announces Positive Three-Year Epioxa® Results Demonstrating Durable Clinical Outcomes in Keratoconus
Three-year data demonstrate sustained improvements in corneal shape, meaningful visual acuity gains, and a favorable long-term safety profile following a single treatment
ALISO VIEJO, Calif., October 07, 2026--Glaukos Corporation (NYSE: GKOS), an ophthalmic pharmaceutical and medical technology company focused on novel therapies for the treatment of glaucoma, corneal disorders, and retinal diseases, announced today positive topline results from a long-term Phase 3 extension study (GLK-202-03) evaluating the durability, visual outcomes, and safety of Epioxa®, the company's groundbreaking epi-on corneal cross-linking therapy for the treatment of keratoconus, a sight-threatening corneal disease that remains significantly undiagnosed and undertreated. The extension study followed a cohort of patients for three years after cross-linking treatment in Epioxa's second Phase 3 pivotal trial (GLK-202-02).
The long-term follow-up results demonstrated durable efficacy and a favorable long-term safety profile through three years following a single Epioxa treatment, with no additional intervention during the extension period. Treated eyes achieved a sustained 1.9 diopter (D) improvement in maximum corneal curvature (Kmax) from baseline, reflecting meaningful long-term corneal flattening and stabilization. Treated eyes also demonstrated clinically meaningful visual outcomes at year 3, with 29% and 20% of eyes gaining two or more and three or more lines of best-corrected visual acuity from baseline, respectively. The durability of these findings further supports Epioxa's potential to provide long-term disease stabilization following a single treatment. In addition, treated eyes maintained a favorable long-term safety profile through three years, with no serious adverse events, treatment-related adverse events, or discontinuations due to adverse events.
"These long-term results further reinforce the potential of Epioxa to provide durable clinical benefits for patients living with keratoconus," said Thomas Burns, chairman and chief executive officer of Glaukos. "The sustained improvements in corneal shape and visual acuity, coupled with an excellent long-term safety profile, reinforce our view that Epioxa represents a transformative treatment advancement for keratoconus patients."
GLK-202-03 is a long-term extension study designed to evaluate the safety, durability, and clinical outcomes of a cohort of patients who completed the Phase 3 GLK-202-02 trial and received corneal cross-linking treatment during the initial study period. Patients were followed for up to 3 years after treatment, with efficacy assessments focused on changes in corneal curvature and visual acuity. A total of 38 study eyes from 35 subjects participated, and 92% of eyes completed the year 3 visit.