By Chris Wack

Palatin Technologies Inc. said it completed an end-of-Phase 2 meeting with the U.S. Food and Drug Administration for PL9643 for the treatment of dry eye disease.

The biopharmaceutical company said the meeting scope included all aspects of PL9643's development plan, with the FDA and Palatin reaching agreement on all key elements of a pivotal Phase 3 clinical program, including study design, endpoints, interim assessment, and patient population.

Palatin said a potential second Phase 3 study and long-term safety study were discussed to support a new drug application.

Palatin remains on track to initiate the Phase 3 program in dry eye disease patients during the fourth quarter of calendar year 2021, with data readout expected in the second half of calendar year 2022. If the program progresses as planned, an NDA submission is targeted for the second half of calendar year 2023.

PL9643 is a novel melanocortin agonist, delivered to the eye topically via eyedrops. Palatin previously announced positive results in its Phase 2 study of PL9643 for the treatment of dry eye disease. There were no safety signals identified and PL9643 had excellent ocular tolerability.

Palatin shares were up 15% to 63 cents in premarket trading.

Write to Chris Wack at chris.wack@wsj.com

(END) Dow Jones Newswires

06-29-21 0818ET