Palatin Technologies Announces First Patient Enrolled in Dry Eye Disease Phase 2 Clinical Trial With PL9643

Palatin Technologies announced that it has enrolled the first patient in a phase 2 clinical trial of topical PL9643, a melanocortin 1/5 receptor (MC1/5r) agonist, for the treatment of dry eye disease (DED).

“We are pleased to initiate this phase 2 study of PL9643 exploring treatment of both the signs of eye damage and the physical symptoms experienced by patients with dry eye disease,” Carl Spana, PhD, President and CEO of Palatin, said in a company news release. “Millions of people suffer from DED and the market is underserved, with a significant percentage of patients not refilling their prescriptions for some DED drugs after their initial use. We believe that PL9643’s potentially quick onset to efficacy and more favorable tolerability and safety profile compared to existing treatments may allow for substantial penetration of the dry eye market. We expect to report data from this study in the fourth quarter of this calendar year.”  

The phase 2 study is a multicenter, randomized double-masked and placebo-controlled study evaluating the efficacy and safety of PL9643 ophthalmic solution (topical eye drops) compared to placebo for the treatment of the signs and symptoms of dry eye. The study is designed to enroll up to 150 participants at three sites in the United States. Patients will be randomized in a 1:1 ratio into two arms, PL9643 or placebo, and will undergo 12-weeks of treatment. The two primary endpoints are inferior corneal fluorescein staining and ocular discomfort. There are several secondary and exploratory outcome measures as well.

For more information about the study, including inclusion/exclusion criteria, a clinical trial synopsis can be found on clinicaltrials.gov (NCT04268069).