Glaukos has commenced a Phase 2 clinical program for its third-generation iLink therapy designed to treat keratoconus.
The ophthalmic medical technology and pharmaceutical company’s iLink platform consists of novel single-use drug formulations that are bio-activated through the delivery of ultraviolet light to the cornea to induce corneal cross-linking designed to strengthen, stabilise, and reshape the cornea.
Glaukos’ third-generation iLink therapy is a corneal cross-linking treatment designed to customise the therapeutic capabilities, streamline the patient experience and build upon Glaukos’ first-generation iLink therapy, known as iLink Epi-off, and its second-generation iLink investigational therapy, known as iLink Epi-on.
“As we do with all of our platforms, we continue to drive subsequent generations of future innovation, and we are delighted to announce the commencement of this Phase 2 clinical program for our third-generation iLink therapy,” Glaukos president and CEO Mr Thomas Burns said.
“Our third-generation iLink therapy builds upon our proven iLink platform therapies and we are delighted to have the opportunity to explore what this promising investigational therapy can do for keratoconus patients in our Phase 2 trials.”
The third-generation iLink Phase 2 clinical program consists of two separate multi-centre, randomised, controlled trials designed to evaluate the safety and efficacy of patient-specific, customised versus non-customised treatment patterns for corneal cross-linking and a new investigational laser-based bio-activation system, respectively.
The company anticipates it will enrol keratoconus patients across both trials at clinical sites in the United States, Europe, South America and Asia. Both trials are designed to have a primary safety and efficacy follow-up period of six months.
Glaukos’ iLink V technology is the first and only FDA- approved corneal cross-linking procedure that slows or halts progressive keratoconus.