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The company expects to enroll patients diagnosed with keratoconus in two trials at clinical sites in the US, South America, Europe, and Asia.
Glaukos Corporation announced today that it has begun a phase 2 clinical program for its third generation iLink therapy.
Designed to treat keratoconus, the iLink pharmaceutical platform includes novel single-use drug formulations that are bioactivated by proprietary systems through the delivery of ultraviolet (UV) light to the cornea in order to induce corneal cross-linking, which in turn strengthens, stabilizes, and reshapes the cornea, according to a news release.
The third-generation iLink works by customizing therapeutic capabilities, streamlining patients’ experience, and building on the first-generation therapy (iLink Epi-off) and second-generation investigational therapy (iLink Epi-on).
The phase 2 clinical program for the third-generation iLink includes two separate multi-center, randomized, controlled trials that evaluate the safety and efficacy of patient-specific, customized versus non-customized treatment patterns for corneal cross-linking and a new investigational laser-based bio-activation system, respectively, according to the release.
Glaukos expects to enroll patients diagnosed with keratoconus across both trials at clinical sites in the US, South America, Europe, and Asia. A primary safety and efficacy follow-up period of 6 months will follow both trials.