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Industry News

19 Jan 2022

Presbyopia and Dry Eye Treatment Phase 2 Clinical Trials To Begin

glaukosGlaukos Corporation, an ophthalmic medical technology and pharmaceutical company focused on novel therapies for the treatment of glaucoma, corneal disorders and retinal diseases, recently announced that it has enrolled the first patient into a Phase 2 clinical trial of GLK-302 for the treatment of presbyopia. GLK-302 is the second investigational drug candidate utilizing Glaukos’ iLution platform’s patented cream-based drug formulations that are applied to the outer surface of the eyelid for dropless transdermal delivery of pharmaceutically active compounds for the treatment of eye disorders. GLK-302’s active pharmaceutical ingredient is pilocarpine.

The Phase 2 multi-center, randomized, double-masked, placebo-controlled trial is designed to evaluate the safety and efficacy of three different dose levels of GLK-302 administered twice daily (BID) to the eyelid versus placebo over 28 days, for improving mesopic, high-contrast, binocular distance corrected near visual acuity (DCNVA) while not deteriorating binocular best corrected distance visual acuity (BCDVA) in presbyopic patients. The company anticipates it will enroll approximately 120 presbyopic patients in the study across clinical sites in the United States.

We believe iLution has the potential to address the major unmet need for presbyopic patients by providing an effective, easy to administer, safe, dropless transdermal therapeutic. Today’s announcement represents a significant milestone in the development of our iLution platform and for our company,” said Thomas Burns, Glaukos president and chief executive officer. “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. We are privileged to have the opportunity to explore what GLK-302 can do for presbyopic patients in our Phase 2 trial.

Presbyopia is a natural part of aging due to the hardening of the eye’s crystalline lens over time, resulting in a loss of lens elasticity or the ability of the lens to change shape in order to focus incoming light on the retina. With this loss of flexibility, eyes are less able to adjust properly to focus on near objects. Presbyopia usually becomes noticeable around the age of 40 and there is no proven way to stop or reverse the progression of presbyopia.

GLK-302 is a sterile ophthalmic topical cream to be applied to the eyelid for the treatment of presbyopia. The cream formulation acts as a depot allowing pilocarpine to be delivered through the dermis of the eyelid to the eye.

Glaukos Corporation also announced that it has enrolled the first patient into a Phase 2 clinical trial of GLK-301 for the treatment of signs and symptoms of Dry Eye Disease (DED). GLK-301 is the first investigational drug candidate utilizing Glaukos’ iLution platform’s patented cream-based drug formulations that are applied to the outer surface of the eyelid for dropless transdermal delivery of pharmaceutically active compounds for the treatment of eye disorders. GLK-301’s active pharmaceutical ingredient is pilocarpine.

The Phase 2 multi-center, randomized, double-masked, placebo-controlled trial is designed to evaluate the safety and efficacy of three different dose levels of GLK-301 administered twice daily (BID) to the eyelids versus placebo over 28 days, followed by a 14-day safety follow-up period, in patients diagnosed with DED. Endpoints will include standard signs and symptoms characteristic of DED. The company anticipates it will enroll approximately 200 DED patients in the study across clinical sites in the United States. Additionally, approximately 20 patients with a diagnosis of DED due to Sjogren’s Syndrome will also be enrolled.

Dry Eye Disease is a common ocular inflammation condition with high unmet clinical need, representing one of the world’s largest ophthalmic markets worldwide. Today’s announcement represents a significant milestone in the development of our iLution platform and for our company,” said Thomas Burns, Glaukos president and chief executive officer. “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. We are delighted to have the opportunity to explore what GLK-301 can do for DED patients in our Phase 2 trial.

GLK-301 is a sterile ophthalmic topical cream to be applied to the eyelids for the treatment of signs and symptoms of DED. The cream formulation acts as a depot allowing pilocarpine to be delivered through the dermis of the eyelid to the eye.

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