FDA Grants Urcosimod 0.05% Compassionate Use for Neuropathic Corneal Pain
Here’s a summary of the article,focusing on the key details:
Urcosimod Receives FDA Authorization for Expanded Access in Severe Neuropathic Corneal Pain
* What happened: The FDA has authorized expanded access Investigational New Drug (IND) application for urcosimod,allowing its use in a single patient with severe neuropathic corneal pain under a physician-sponsored program.
* Why it matters: Neuropathic corneal pain is a debilitating condition with no current FDA-approved treatments. Urcosimod offers a potential new hope due to its dual mechanism of action – targeting both immune-mediated inflammation and dysfunctional nerve signaling.
* About Urcosimod: It’s a lipid conjugated chemerin peptide agonist of the ChemR23 G-protein coupled receptor, found in immune cells of the eye.
* previous Research:
* A Phase 2 study (18 patients) showed statistically significant pain reduction with urcosimod.
* Another Phase 2 study (240 patients) with dry eye disease showed statistically significant improvements in multiple endpoints.
* Future Plans: A Phase 2b/3 study with 120 patients is planned for later this year.
* FDA Designation: The FDA granted fast track designation to urcosimod for neuropathic corneal pain in May 2025.
* Key People:
* Pedram hamrah, MD: Filed the IND with the FDA and is leading the investigation.
* robert J. Dempsey: CEO of Okyo, the company developing urcosimod.