OKYO Pharma has received positive feedback from the US Food and Drug Administration (FDA) following a Type D meeting, providing regulatory support for advancing its investigational therapy, urcosimod, into a global Phase 3 pivotal trial for Neuropathic Corneal Pain (NCP).

The FDA's feedback validated the design of the company's planned NEPTUNE Phase 3 clinical trial and provided greater clarity on its regulatory strategy. According to OKYO Pharma, the planned study is being positioned as a pivotal trial that could potentially support a single-trial registration pathway, subject to successful clinical outcomes and continued FDA review.

The company said the regulatory guidance reduces development uncertainty and strengthens its plans to move directly into global Phase 3 development.

Urcosimod is the first investigational therapy being developed specifically for neuropathic corneal pain under an active Investigational New Drug (IND) application and has previously received Fast Track designation from the FDA. The designation reflects the significant unmet medical need in treating the condition, for which there are currently no FDA-approved therapies.

Neuropathic corneal pain is a chronic and debilitating disorder caused by damage or dysfunction of the corneal nerves, often accompanied by inflammation. Patients experience persistent eye pain, light sensitivity and, in some cases, facial or head pain that may be disproportionate to visible clinical findings. Due to the lack of approved treatment options, patients are often managed with off-label topical or systemic medications with varying levels of effectiveness.

Urcosimod is a first-in-class lipid-conjugated chemerin peptide agonist targeting the ChemR23 G-protein-coupled receptor. The therapy is designed to provide both analgesic and anti-inflammatory effects by acting on immune cells within the eye as well as neurons involved in pain signalling, potentially offering a novel treatment approach for neuropathic corneal pain.

The company plans to initiate the global Phase 3 NEPTUNE trial as the next step in its clinical development programme, aiming to generate data to support future regulatory submissions.