WASHINGTON (dpa-AFX) - Biopharmaceutical company Palatin Technologies, Inc. (PTN) announced Wednesday the reinitiation of enrollment of its Phase 2 clinical study with PL9643 for the treatment of dry eye disease (DED). The company had paused patient recruitment to ensure patient safety during the initial phases of the COVID-19 pandemic.
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.
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.
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.
Copyright RTT News/dpa-AFX
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