- Palatin Technologies ( NYSE: PTN ) said a data monitoring committee (DMC) recommended to continue a phase 3 trial of PL9643 to treat patients with dry eye disease (DED) after review of an interim analysis of the study was completed.
- The interim analysis included data on efficacy and safety of PL9643 ophthalmic solution in the first 120 patients who had completed therapy in the study, dubbed MELODY-1.
- No safety concerns were identified by the DMC, the company said in an Aug. 16 press release.
- Palatin added that the DMC recommended that the study continue with a sample size target of up to 350 patients. The DMC had the option to recommend a sample size of up to 600 patients.
- The company noted that it plans to enroll up to the additional 230 patients recommended by the panel.
- Palatin expects topline results from the study in Q2 of calendar year 2023.
- DED is a condition in which the tears do not provide adequate lubrication in the eye, leading to dryness and inflammation.
- PTN +5.76% to $0.37 premarket Aug. 16
For further details see:
Palatin stock rises as panel recommends continuing phase 3 dry eye study