Glaukos Announces First Patient Enrolled in Phase 2 Clinical Trial for Presbyopia
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
“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
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.
All statements other than statements of historical facts included in this press release that address activities, events or developments that we expect, believe or anticipate will or may occur in the future are forward-looking statements. Although we believe that we have a reasonable basis for forward-looking statements contained herein, we caution you that they are based on current expectations about future events affecting us and are subject to risks, uncertainties and factors relating to our operations and business environment, all of which are difficult to predict and many of which are beyond our control, that may cause our actual results to differ materially from those expressed or implied by forward-looking statements in this press release. These potential risks and uncertainties include, without limitation, the timing and extent to which we are successful in our clinical trials evaluating the safety and efficacy of iLution, the extent to which we may obtain regulatory approval for iLution or other investigational products, our ability to successfully commercialize such products, the ability to obtain and maintain adequate financial coverage and reimbursement for our products, and the continued efficacy and safety profile of our products. These and other risks, uncertainties and factors related to
Sr. Director, Investor Relations & Corporate Strategy & Development