WASHINGTON (dpa-AFX) - Biopharmaceutical company Palatin Technologies, Inc. (PTN) on Tuesday announced positive results in its Phase 2 study of PL9643 for the treatment of dry eye disease or DED.
According to the company, data showed statistically significant improvement in multiple signs and symptoms in the moderate to severe patient population after 2 weeks of dosing and at the 12-week visit. There were no safety signals identified and PL9643 had excellent ocular tolerability.
Based on these positive trial results, Palatin plans to initiate a Phase 2/3 trial in the U.S. in mid-calendar year 2021.
However, the company added that statistical significance for the primary endpoints was not reached in the overall enrolled population that included mild, moderate, and severe patients, as measured at the 12-week primary evaluation visit.
'With approximately 20 million adults in the United States currently suffering from DED, the majority being moderate to severe patients, and up to 50% discontinuing treatment due to slow onset, lack of efficacy or intolerance, PL9643's potentially quick onset of efficacy and excellent tolerability profile are differentiating factors to current approved therapies,' said Carl Spana, President and CEO of Palatin.
This Phase 2 study was a multi-center, randomized, double-masked and vehicle-controlled study evaluating the efficacy and safety of PL9643 ophthalmic solution (topical eye drops) compared to vehicle for the treatment of the signs and symptoms of dry eye.
The study enrolled 160 participants randomized in a 1:1 ratio into two arms, PL9643 or vehicle, at four sites in the U.S. Patients underwent 12 weeks of daily treatment.
Palatin said it expects to present detailed study results at the Association for Research in Vision and Ophthalmology (ARVO) 2021 Annual Meeting.
Copyright RTT News/dpa-AFX
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