Palatin releases updated results from responder analyses of phase 3 Melody-1 trial in dry eye

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Palatin has released updated results from responder analyses of its pivotal phase 3 Melody-1 clinical trial evaluating the safety and efficacy of PL9643 versus placebo in the treatment of dry eye disease (DED).

The company noted¹ that responder analysis was conducted to evaluate the percentage of patients achieving complete symptom resolution across 13 pre-specified symptom endpoints. The Symptom Composite Score, which averages individual Visual Analog Scale (VAS) ratings to provide a comprehensive assessment of symptom improvement, was used to quantify overall symptom burden from the patient's perspective.

Results showed that in 6 of the 13 symptom endpoints, a significantly higher percentage of patients treated with PL9643 achieved complete symptom resolution compared to placebo (p< 0.05) at 12 weeks. According to the company, this level of symptom resolution has not been achieved by any FDA-approved dry eye therapies to date.

Additionally, the Symptom Composite Score for PL9643-treated patients showed statistically significant symptom resolution at 2 weeks, with continued improvement through 12 weeks and no signs of plateau. While symptom resolution with PL9643 was evident as early as 2 weeks, an increasing number of symptoms reaching statistical significance from week 4 through week 12 were seen. While patients treated with placebo showed minimal improvement that quickly plateaued. Across all 13 symptom endpoints, a higher percentage of patients in the PL9643 group achieved complete symptom resolution compared to those receiving placebo.

Carl Spana, PhD, president and CEO of Palatin Technologies, commented on the results in a press release from the company.

“These results reinforce PL9643's potential as a best-in-class therapy with a differentiated mechanism of action. Combined with its rapid, sustained efficacy and excellent safety and tolerability profile, PL9643 offers a compelling new option for patients. Critically, these outcomes align with key FDA approval criteria for symptom improvement based on responder analyses […] No currently approved DED treatment offers PL9643's exceptional safety and tolerability profile, rapid onset of efficacy, and statistically significant results across multiple symptom and sign endpoints — including a significantly higher percentage of patients achieving complete symptom resolution, which is a highly differentiating factor from currently approved therapies," said Spana.

Palatin originally announced results from the Melody-1 trial early in 2024.² PL9643 treatment demonstrated clinically meaningful and statistically significant results for the co-primary symptom endpoint of pain (p<0.025) and multiple other symptom endpoints not named by the company. However, while the co-primary sign endpoint and secondary sign endpoints demonstrated positive treatment effects over vehicle in the Intent-to-Treat (ITT) population, they did not achieve statistical significance.

Remaining phase 3 clinical programs include Melody-2 and Melody-3, each evaluating both sign and symptom endpoints. The company noted that patient enrollment could begin in the second half of 2025, with topline data in the second half of 2026.

References:

1. Palatin Announces Breakthrough Symptom Resolution in Updated Analyses from Phase 3 PL9643 MELODY-1 Clinical Trial in Dry Eye Disease. Published April 29, 2025. Accessed April 29, 2025. https://www.prnewswire.com/news-releases/palatin-announces-breakthrough-symptom-resolution-in-updated-analyses-from-phase-3-pl9643-melody-1-clinical-trial-in-dry-eye-disease-302440906.html

2. Harp M. Palatin announces results of Melody-1 phase 3 trial for treatment of dry eye disease. Released March 1, 2024. Accessed April 29, 2025. https://www.ophthalmologytimes.com/view/palatin-announces-results-of-melody-1-phase-3-trial-for-treatment-of-dry-eye-disease