Glaukos' iLink Therapy Meets Primary Endpoint In Late-Stage Vision Disorder Study

Glaukos Corp (NYSE: GKOS) has announced topline data from the U.S. Phase 3 trial evaluating its corneal cross-linking iLink therapy to treat keratoconus.
Keratoconus is characterized by cone-shaped cornea causing blurred vision and sensitivity to light and glare.
The study met its primary efficacy endpoint, demonstrating a statistically significant improvement in maximum corneal curvature (Kmax), versus placebo arm, at six months from baseline.
Kmax is an objective measurement of the steepest corneal curvature based on corneal topography, where an increasing Kmax denotes corneal steepening and keratoconus disease progression.
The study also demonstrated the ability of Epi-on to halt or reduce the keratoconus disease progression in the treated arm versus observed disease progression in the placebo-control arm.
98% of patients randomized to the placebo-control arm elected to cross-over to Epi-on treatment after the 6-month primary efficacy evaluation period.
The treatment was generally well-tolerated on the safety front, with 97% of enrolled treatment patients completing the 12-month trial. No patients discontinued early due to an adverse event.
Marketing application submission is expected in 2022, with FDA approval anticipated in 2023.
Price Action: GKOS shares closed 4.6% lower at $92.1 on Thursday.