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

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  • 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.
 

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Posted-In: Keratoconus Phase 3 Vision DisorderBiotech News Health Care FDA General

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