Palatin Announces Enrollment Reinitiation of PL9643 Study for Dry Eye Disease

Palatin Technologies announced reinitiation of enrollment of its Phase 2 study with PL9643 for the treatment of dry eye disease (DED).

After pausing patient recruitment to ensure patient safety during the initial phases of the COVID-19 pandemic, Palatin has commenced patient recruitment in its PL9643 Phase 2 clinical study in subjects with dry eye disease. Patient enrollment is currently expected to be complete within the next 30-45 days, with data readout targeted for the fourth quarter of calendar year 2020.

"We are very happy to resume patient recruitment in 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.

This Phase 2 study is a multi-center, randomized double-masked, placebo-controlled study evaluating the safety and efficacy of PL9643 ophthalmic solution (topical eye drops) compared to placebo for the treatment of the signs and symptoms of dry eye disease. 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. For more information about the study, including inclusion/exclusion criteria, a clinical trial synopsis can be found on clinicaltrials.gov

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.