---
schema_version: "secwatch.filing_event.v1"
accession: "0001654954-23-011637"
form_type: "8-K"
ticker: "PTN"
cik: "0000911216"
company_name: "PALATIN TECHNOLOGIES INC"
filed_at: "2023-09-07T23:59:59+00:00"
generated_at: "2026-06-10T23:09:46.267806+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.65
calibrated_materiality_score: 0.65
confidence: "high"
source: SEC EDGAR
---

# Palatin completes enrollment in Phase 3 dry eye study (PL9643); 570 patients enrolled, topline expected Q4 2023

## Summary
- 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.

## SEC filing metadata
- accession: 0001654954-23-011637
- form_type: 8-K
- ticker: PTN
- cik: 0000911216
- company_name: PALATIN TECHNOLOGIES INC
- filed_at: 2023-09-07T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.65
- calibrated_materiality_score: 0.65
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/911216/000165495423011637/0001654954-23-011637-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/911216/000165495423011637/ptn_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001654954-23-011637
- JSON: https://secwatch.observer/filing/0001654954-23-011637.json
- Plain text: https://secwatch.observer/filing/0001654954-23-011637.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.