OKYO Pharma is accelerating the development of its lead investigational therapy, urcosimod, after receiving positive feedback from the US FDA on its clinical and regulatory strategy for treating neuropathic corneal pain (NCP).

 

Following a successful FDA Type D meeting, the clinical-stage biopharmaceutical company said it has finalized plans for its global Phase 3 pivotal trial, known as NEPTUNE (Neuropathic Eye Pain Treatment with Urcosimod & Nerve Evaluation), which will be conducted across the United States and Europe.

 

The FDA’s feedback provided alignment on a single-dose Phase 3 study design and strengthened the possibility of a potential single-trial registration pathway, reducing uncertainty around the company’s development plan and allowing OKYO to advance directly toward a pivotal study.

 

"The outcome of our Type D meeting represents an important milestone and de-risking of our development program,” said Flavio Mantelli, Chief Medical Officer of OKYO Pharma. 

 

“The FDA’s feedback provided regulatory validation of our upcoming NEPTUNE clinical trial design, accelerating both the clinical development plan for urcosimod and our ability to generate meaningful data for patients, physicians, and regulators.”

 

The NEPTUNE trial is expected to enroll approximately 111 patients, with participants randomized 2:1 to receive either 0.05% urcosimod or placebo. OKYO said the study is designed to support a potential registration strategy, subject to successful outcomes and continued FDA review.

 

"Our strong balance sheet, together with regulatory clarity from the FDA supporting our accelerated clinical development plan, positions us to advance directly into our global Phase 3 urcosimod trial,” said Robert J. Dempsey, Chief Executive Officer of OKYO Pharma. 

 

“Most importantly, we remain committed to bringing a potential first in class, non-opioid treatment to patients living with this debilitating condition, for which there are currently no FDA-approved therapies.”