OKYO Pharma Taps Former Dompé CMO to Lead Urcosimod Development
Event summary
- OKYO Pharma appoints Flavio Mantelli, MD, PhD as Chief Medical Officer, effective February 10, 2026.
- Dr. Mantelli previously led the development of Dompé's blockbuster orphan drug Oxervate®, which achieved $1B+ in sales in 2024.
- He will oversee clinical and regulatory strategy for urcosimod, OKYO's lead candidate for neuropathic corneal pain (NCP).
- Urcosimod has FDA Fast Track designation and is set for a Phase 2b/3 trial in 2026.
The big picture
OKYO Pharma is bolstering its leadership with seasoned ophthalmology executives to drive urcosimod's development, a move that underscores the company's focus on addressing high-unmet needs in corneal pain. Dr. Mantelli's track record with Oxervate® suggests OKYO is prioritizing regulatory efficiency and commercial scalability, critical for a clinical-stage biotech targeting orphan indications. The appointment follows recent FDA Fast Track designation, signaling confidence in urcosimod's differentiated mechanism.
What we're watching
- Clinical Execution
- Whether Dr. Mantelli can replicate his Oxervate® success in advancing urcosimod through pivotal trials.
- Regulatory Momentum
- The pace at which FDA alignment on Phase 2b/3 design translates into accelerated approval pathways.
- Market Differentiation
- How OKYO positions urcosimod against emerging therapies in the underserved NCP space.