Glaukos Corporation announced positive top-line results from a long-term phase 3 extension study (GLK-202-03) evaluating the durability, visual outcomes, and safety of Epioxa, the company's epi-on corneal cross-linking therapy for the treatment of keratoconus. The extension study followed a cohort of patients for 3 years after cross-linking treatment in Epioxa’s second phase 3 pivotal trial (GLK-202-02), the company said in a press release. 

According to Glaukos, the long-term follow-up results demonstrated durable efficacy and a favorable long-term safety profile through 3 years following a single Epioxa treatment, with no additional intervention during the extension period. Treated eyes achieved a sustained 1.9 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 2 or more and 3 or more lines of best-corrected visual acuity from baseline, respectively. In addition, treated eyes maintained a favorable long-term safety profile through 3 years, with no serious adverse events, treatment-related adverse events, or discontinuations due to adverse events.

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, the company said in the press release.