Glaukos Announces Positive Phase 3 Trial Results for iLink™ Epi-on Investigational Therapy That Met the Primary Efficacy Endpoint
Study Met Primary Efficacy Endpoint with Statistically Significant Improvement in Maximum Corneal Curvature at 6 Months
Epi-on Treatment Demonstrated the Ability to Halt or Reduce the Progression of Keratoconus versus Observed Disease Progression in a Placebo-Control Arm
Data Suggest Epi-on Has the Potential to Provide the Ophthalmic Community and Keratoconus Patients with the First Non-Invasive, Bio-Activated Drug Therapy Alternative for Keratoconus
Data to Serve as the Basis for U.S. NDA Submission in 2022
SAN CLEMENTE, Calif.–(BUSINESS WIRE)–Glaukos Corporation (NYSE: GKOS), an ophthalmic medical technology and pharmaceutical company focused on novel therapies for the treatment of glaucoma, corneal disorders and retinal diseases, today announced that U.S. Phase 3 pivotal trial results for its next-generation corneal cross-linking iLink™ therapy for the treatment of keratoconus, known as Epi-on, met the study’s primary efficacy endpoint, demonstrating a statistically significant improvement in maximum corneal curvature (Kmax) at 6 months from baseline between the treated and placebo-controlled arms. 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 Epi-on multi-center, randomized, placebo-controlled, Phase 3 pivotal trial was designed to evaluate the safety and efficacy of Glaukos’ iLink Epi-on therapy in impeding the progression of, and/or reducing Kmax in eyes with progressive keratoconus. The study eyes were randomized in a 2:1 ratio to receive Epi-on therapy or placebo-control treatment. The study’s primary efficacy endpoint is a difference of ≥ 1 diopter (D) between treatment and control arms in the mean change in Kmax from baseline to Month 6. The study enrolled 279 eyes across 14 clinical sites in the United States, including 189 eyes randomized to the treatment arm and 90 eyes randomized to the control arm. Following the completion of the 6-month primary efficacy and safety evaluation period, the patients randomized to placebo were able to cross-over and receive the Epi-on treatment. All patients were then followed for another 6 months for safety and efficacy evaluation.
Glaukos (www.glaukos.com) is an ophthalmic medical technology and pharmaceutical company focused on novel therapies for the treatment of glaucoma, corneal disorders and retinal diseases. The company pioneered Micro-Invasive Glaucoma Surgery, or MIGS, to revolutionize the traditional glaucoma treatment and management paradigm. Glaukos launched the iStent®, its first MIGS device, in the United States in 2012, its next-generation iStent inject® device in the United States in 2018, and most recently, the iStent inject W device in 2020. In corneal health, Glaukos’ proprietary suite of single-use, bio-activated pharmaceuticals are designed to strengthen, stabilize and reshape the cornea through a process called corneal collagen cross-linking to treat corneal ectatic disorders and correct refractive conditions. Glaukos is leveraging its platform technology to build a comprehensive and proprietary portfolio of micro-scale surgical and pharmaceutical therapies in glaucoma, corneal health and retinal disease.