Palatin Technologies 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," said Carl Spana, Ph.D., President and CEO of Palatin. "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 multi-center, 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 US. 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.
Dry eye disease is a common inflammatory disease that, left untreated, can become extremely painful and lead to permanent damage to the cornea and vision. Dry eye disease affects the cornea and conjunctiva of the eye resulting in irritation, redness, pain and blurred vision. It is estimated to affect over 30 million people in the United States. The disease is characterized by insufficient moisture and lubrication in the anterior surface of the eye, leading to dryness, inflammation, pain, discomfort, irritation, diminished quality of life, and in severe cases, permanent vision impairment. Existing therapy for dry eye disease is generally regarded as inadequate by many physicians and patients, and often requires weeks or months to demonstrate activity.
