other material
confidence high
sentiment positive
materiality 0.65
Palatin completes enrollment in Phase 3 dry eye study (PL9643); 570 patients enrolled, topline expected Q4 2023
PALATIN TECHNOLOGIES INC
- PL9643 MELODY-1 Phase 3 study enrolled 570 patients with moderate-to-severe dry eye disease.
- Topline data anticipated by end of Q4 2023; interim analysis of first 120 patients showed safety and efficacy.
- Assuming positive results, NDA submission to FDA expected mid-2025 after two more Phase 3 studies in 2024-2025.
- Company highlighted PL9643's novel mechanism of action and differentiated profile vs. current DED treatments.