- Palatin Technologies (NYSE:PTN) announces the completion of an End-of-Phase 2 (EOP2) meeting with the U.S. FDA for PL9643 for the treatment of dry eye disease (DED).
- Shares up more than 20% premarket.
- The EOP2 meeting scope included all aspects of PL9643's development plan.
- The FDA and Palatin reached agreement on all key elements of a pivotal Phase 3 clinical program, including study design, endpoints, interim assessment, and patient population.
- Palatin remains on track to initiate the late-stage program in DED patients during the fourth quarter of 2021, with data readout expected in the second half of 2022.
- If the program progresses as planned, an NDA submission is targeted for the second half of 2023, the company said.