Palatin Technologies announced completion of enrollment of its phase 2 study with PL9643 for the treatment of dry eye disease (DED).
After delaying enrollment of new patient groups due to the COVID-19 pandemic, Palatin reinitiated enrollment in its PL9643 phase 2 clinical study in subjects with dry eye disease last month. With enrollment completed, data readout is targeted for the fourth quarter of calendar year 2020.
“We are pleased to complete enrollment in this phase 2 study. We believe that, if approved, PL9643’s potentially quick onset to efficacy and favorable tolerability and safety profile may provide a viable treatment option to the significant percentage of patients not refilling their prescriptions for some DED drugs after their initial use,” Carl Spana, PhD, President and CEO of Palatin, said in a company news release.
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 US. Patients were randomized in a 1:1 ratio into two arms, PL9643 or placebo, and 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.