Palatin Announces Breakthrough Symptom Resolution in Updated Analyses from Phase 3 PL9643 MELODY-1 Clinical Trial in Dry Eye Disease

Core Insights - Palatin Technologies has announced updated results from the Phase 3 MELODY-1 clinical trial for PL9643, indicating its potential as a first-in-class therapy for dry eye disease (DED) with full symptom resolution [2][3][4] Clinical Trial Results - The responder analysis showed statistically significant complete symptom resolution across multiple endpoints, with six out of thirteen symptom endpoints demonstrating a higher percentage of patients achieving resolution with PL9643 compared to placebo (p<0.05) [6][7] - The Symptom Composite Score for PL9643-treated patients indicated significant symptom resolution by week 2, with continued improvement through week 12, while the placebo group showed minimal improvement that plateaued early [6][7] - The Phase 3 MELODY-1 trial involved 575 patients and met statistical significance for the co-primary symptom endpoint of pain (P<0.025) and seven secondary symptom endpoints (P<0.05) [10] Regulatory and Market Context - The findings align with FDA approval guidance for dry eye drug development, which supports the use of responder analyses to demonstrate symptom improvement [9] - The dry eye disease market is projected to grow from an estimated $6.11 billion in 2024 to $7.46 billion by 2029, at a CAGR of 4.09% [11] Company Strategy and Future Plans - Palatin Technologies aims to finalize collaboration deals in the second half of the year and plans to begin patient enrollment for the remaining Phase 3 studies (MELODY-2 and MELODY-3) in the same timeframe [9][10] - The company focuses on developing first-in-class medicines targeting significant unmet medical needs, particularly in the area of dry eye disease [14]