Key Takeaways

  • FDA Type D meeting feedback supports OKYO Pharma's planned global phase 3 NEPTUNE trial design for urcosimod in neuropathic corneal pain
  • The agency's guidance could support a potential single-trial registration strategy, pending successful trial results and continued FDA review
  • Urcosimod has FDA Fast Track designation and is being developed as a potential first-in-class, non-opioid therapy for neuropathic corneal pain

OKYO Pharma reported positive feedback from a Type D meeting with the FDA, providing regulatory alignment for the company's planned phase 3 clinical development program evaluating urcosimod for neuropathic corneal pain (NCP).

According to the clinical-stage biopharmaceutical company, the FDA's feedback supports its proposed regulatory and clinical strategy for urcosimod and validates the design of the planned global phase 3 NEPTUNE trial. The company said the guidance reduces regulatory uncertainty and supports advancement of the investigational therapy into pivotal-stage development.

"The outcome of our Type D meeting represents an important milestone and de-risking of our development program," said Flavio Mantelli, MD, PhD, 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."

Based on discussions during the meeting, OKYO said it intends to position the NEPTUNE study as a pivotal trial that could potentially support a single-trial registration strategy, contingent on positive study results and continued FDA review. While the agency's feedback does not constitute approval of a future marketing application, the company believes it provides a clearer path forward for its development program.

"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, CEO 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."

Urcosimod is an investigational therapy being developed for the treatment of neuropathic corneal pain and anterior segment eye diseases. According to the company, it is the first investigational therapy with an active investigational new drug (IND) application specifically for neuropathic corneal pain. The candidate has also received FDA Fast Track designation, reflecting the unmet need in a condition for which no FDA-approved therapies are currently available.