California-based ophthalmic medical company Glaukos announced promising topline results from its phase 2a first-in-human clinical trial for GLK-301 (iLution), a sterile topical cream to treat dry eye disease (DED). The cream formulation acts as a depot allowing pilocarpine to be delivered through the dermis of the eyelid to the eye.
The phase 2a multicentre, randomised, double-masked, placebo-controlled trial enrolled 218 US DED patients. It was designed to evaluate the safety and efficacy of three different dose levels of GLK-301 administered twice daily versus placebo over 28 days, followed by a 14-day safety follow-up period. Outcomes included an improvement in tear film quality (tear break-up time) and reduction in blurred vision, said the company. “Based on these encouraging observations, Glaukos plans to advance GLK-301 into a phase 2b clinical trial targeted to begin in 2023.”
In other news, Glaukos also announced the start of patient enrolment in its second phase 3 confirmatory trial for Epioxa, its next-generation corneal crosslinking therapy for keratoconus, and positive results for a prospective, multicentre clinical trial to evaluate the safety of the surgical exchange procedure for iDose TR (travoprost intraocular implant). “We are pleased to clinically confirm the iDoseTR exchange procedure is safe and facile. We look forward to including these positive data in our upcoming new drug application (NDA) submission to further support the safety and tolerability of redosing iDose TR patients over time,” said Thomas Burns, Glaukos chairman and CEO. “We continue to believe iDose TR can be a transformative novel technology able to fundamentally improve the treatment paradigm for patients with glaucoma.”
