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.