OKYO Pharma Hires Ex-Dompé CMO to Advance Fast-Track Urcosimod for Corneal Pain
OKYO Pharma appointed Flavio Mantelli, MD, PhD as Chief Medical Officer to lead clinical and regulatory strategy for its FDA Fast Track urcosimod program in neuropathic corneal pain. Mantelli directed Oxervate’s clinical development to FDA approval and drove sales over $1 billion in 2024, enhancing OKYO’s readiness for Phase 2b/3 trials.
1. Appointment of Chief Medical Officer
On February 10, OKYO Pharma named Flavio Mantelli, MD, PhD as Chief Medical Officer. He will oversee all clinical and regulatory activities for urcosimod, including strategy for upcoming neuropathic corneal pain trials under FDA Fast Track designation.
2. Mantelli’s Track Record in Ophthalmology
Dr. Mantelli previously served as Chief Medical Officer at Dompé, where he led the clinical development and global approval of Oxervate® (cenegermin-bkbj). That orphan therapy surpassed $1 billion in sales in 2024, marking one of the most successful launches in corneal disease.
3. Outlook for Urcosimod Clinical Program
Urcosimod holds FDA Fast Track status for neuropathic corneal pain with the first IND approved. OKYO plans a ~150-subject Phase 2b/3 multiple-dose study in the first half of this year, aiming for pivotal proof-of-concept data to support regulatory approval.