OKYO Pharma Ltd (NASDAQ:OKYO), a clinical-stage biopharmaceutical company focused on therapies for neuropathic corneal pain (NCP) and inflammatory eye diseases, has appointed Flavio Mantelli as its Chief Medical Officer.
Dr Mantelli joins OKYO Pharma with extensive experience in ocular surface drug development, including leading the clinical development and global strategy for Oxervate at Dompé farmaceutici, which reached blockbuster status with sales exceeding $1 billion in 2024.
“Neuropathic corneal pain represents one of the most debilitating and underserved areas in ophthalmology,” Dr Mantelli said in a statement. “OKYO Pharma’s focus on differentiated, mechanism-based approaches to inflammatory eye diseases and neuropathic corneal pain resonates strongly with my career-long dedication to translating breakthrough science into approved innovative therapies.”
In his new role, Dr Mantelli will oversee OKYO’s clinical development strategy, including advancing urcosimod in planned trials for NCP and other orphan indications. The company recently received FDA alignment on its proposed Phase 2b/3 study design and was granted fast-track designation and compassionate use authorization for urcosimod in NCP. OKYO expects to initiate a roughly 150-subject multiple-dose Phase 2b/3 study in the first half of 2026.
“Bringing Dr Mantelli into the executive team is tremendously important as we continue to build a world-class organization focused on ocular surface disease,” said Robert Dempsey, CEO of OKYO Pharma. “Dr Mantelli is an exceptional clinical developer whose leadership of a highly successful orphan drug development program in ophthalmology demonstrates his ability to advance complex corneal programs, capabilities that will be critical as we advance urcosimod forward for neuropathic corneal pain.”
Chairman and founder Gabriele Cerrone added that Dr. Mantelli’s experience developing Oxervate, one of ophthalmology’s most successful orphan drug launches, “will be invaluable for OKYO’s development of urcosimod for patients with NCP.”
OKYO Pharma is developing urcosimod as a first-in-class therapy for NCP, an area with no FDA-approved treatments, and is pursuing additional indications in inflammatory eye diseases.