Palatin reports positive interim analysis in dry eye trial
A phase 3 pivotal study of PL9643, a melanocortin agonist under investigation as a treatment for dry eye disease, demonstrated positive interim results, according to a press release from Palatin Technologies.
The analysis included efficacy and safety data from 120 participants in the multicenter, randomized, double-masked, vehicle-controlled MELODY-1 clinical study. Based on a review of the data, an independent data monitoring committee recommended that the study continue with a sample size target of up to 350 participants.
“The emerging data, including the safety and ocular tolerability, indicate that PL9643 could be a potentially safe and effective treatment for patients with DED,” Carl Spana, PhD, president and CEO of Palatin, said in the release. “Based on trial results to date, we believe PL9643, with its differentiating factors, could provide a fast-acting and well-tolerated treatment option for the millions of patients suffering from DED, and we look forward to presenting topline results of this phase 3 trial in the second quarter of calendar 2023.”
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