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,” Carl Spana, PhD, President and CEO of Palatin, said in a company news release.
This phase 2 study is a multicenter, 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