Glaukos has commenced Phase 2 trials of two investigational cream-based drug candidates that are applied to the eyelids to treat dry eye and presbyopia.
This month the New York Stock Exchange-listed ophthalmic medical technology and pharmaceutical company announced it has enrolled the first patient into a Phase 2 study of GLK-301 for the treatment of signs and symptoms of dry eye disease (DED).
On the same day, it also revealed the first patient had enrolled in a Phase 2 clinical trial of GLK-302 for presbyopia.
Both therapies feature Glaukos’ iLution platform – patented cream-based drug formulations applied to the outer surface of the eyelid. In GLK-301 and GLK-302, the cream formulation acts as a depot allowing the active pharmaceutical ingredient pilocarpine to be delivered through the dermis of the eyelid to the eye.
In patients diagnosed with DED, the Phase 2 multi-centre, randomised, double-masked, placebo-controlled trial will evaluate the safety and efficacy of three different dose levels of GLK-301 administered twice daily to the eyelids versus placebo over 28 days, followed by a 14-day safety follow-up period.
Endpoints will include standard signs and symptoms characteristic of DED. The company anticipates it will enrol approximately 200 DED patients across clinical sites in the US. Additionally, approximately 20 patients with a diagnosis of DED due to Sjogren’s syndrome will be enrolled.
“[This] announcement represents a significant milestone in the development of our iLution platform and for our company,” Mr Thomas Burns, Glaukos president and CEO, said.
“We believe our iLution platform has the potential to address the major unmet need for patients suffering from dry eye disease and other chronic eye diseases by providing an effective, easy-to-administer, safe, dropless transdermal therapeutic.”
The presbyopia Phase 2 trial is designed to evaluate the safety and efficacy of three different dose levels of GLK-302 administered twice daily to the eyelid versus placebo over 28 days, for improving mesopic, high-contrast, binocular distance corrected near visual acuity while not deteriorating binocular best corrected distance visual acuity in presbyopic patients.
The company anticipates approximately 120 presbyopic patients will participate in the study across America.
“The dosing of the first patient in the Phase 2 study brings us one step closer to an innovative near vision solution for the millions of patients who suffer from presbyopia,” Burns stated.
“We are privileged to have the opportunity to explore what GLK-302 can do for presbyopic patients in our Phase 2 trial.”
More reading
FDA approves first presbyopia eye drop
New rules allowing optometrists to prescribe lifitegrast dry eye therapy