Palatin sinks after pivotal dry eye data disappoints
29 Feb 2024
Phase 3Clinical Result
Shares of Palatin Technologies fell more than 38% on Wednesday after the company reported that its experimental dry eye treatment missed both co-primary endpoints and key secondary endpoints in an unadjusted, planned analysis.
The pivotal Phase III MELODY-1 trial enrolled 575 patients with dry eye disease (DED) to receive either melanocortin agonist PL9643 or a vehicle control for 12 weeks. The co-primary endpoints measured pain symptoms and conjunctival lissamine green staining, a clinical sign of efficacy.
While the original analysis of the ophthalmic solution failed to show statistical significance on either endpoint, Palatin said it also conducted an intent-to-treat analysis of the data that adjusted for age and gender, as 60% of study participants were over the age of 60, and 68% were women.
"It is important to note that it is rare for one clinical study in DED to show efficacy for both a sign and a symptom,” CEO Carl Spana said.
Next, Palatin plans to meet with the FDA to guide the design of its next Phase III trial of PL9643 and receive feedback on the treatment’s path to regulatory approval.
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