(RTTNews) - OKYO Pharma Ltd (OKYO), a clinical-stage biopharmaceutical company announced positive feedback from its U.S. Food and Drug Administration (FDA) Type D meeting, validating the regulatory and clinical path forward for Urcosimod in neuropathic corneal pain.
The FDA endorsed the design of a single-dose Phase 3 study and indicated that a potential-single-trial registration pathway could be considered, subject to successful results. This regulatory clarity allows OKYO to accelerate development of Urcosimod, which has already received Fast Track designation.
The pivotal trial, dubbed NEPTUNE (Neuropathic Eye Pain Treatment with Urcosimod & Nerve Evaluation), will enroll approximately 111 patients in the U.S. and Europe. Participants will be randomized 2:1 to receive either 0.05% Urcosimod or placebo. The study aims to address the significant unmet medical need in neuropathic corneal pain (NCP), a debilitating condition with no FDA-approved therapies.
Flavio Mantelli, MD, PhD, Chief Medical Officer of OKYO Pharma, said the FDA's feedback " represents an important milestone and de-risking of our development program," adding that the NEPTUNE trial design provides a clear path to generate meaningful data for patients, physicians and regulators.
Robert J. Dempsey, Chief Executive Officer of OKYO Pharma, emphasized that the company's strong balance sheet and regulatory clarity position it to advance directly into the global Phase 3 trial. He noted, "Most importantly, we remain committed to bringing a potential first in class, non-opioid treatment to patients living with this debilitating condition." Urcosimod is the first investigational therapy with an open IND specifically for the treatment of neuropathic corneal pain. Its Fast Track designation highlights the urgency of developing effective treatments for patients suffering from chronic corneal pain.
OKYO has traded between $1.42 and $3.34 over the past year. The stock closed Tuesday's trading at $1.75, up 8.70%. In pre-market trading, the stock is at $1.71, down 2.25%.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
