The FDA has given a thumbs-up to Okyo Pharma's plans for a phase 3 trial of urcosimod, a novel therapy for neuropathic corneal pain — a debilitating eye condition with no currently approved treatments. The NEPTUNE trial will enroll ~111 patients across the U.S. and Europe, and if successful, could support FDA approval without additional studies needed.
Okyo Pharma got a major regulatory green light: the FDA favorably reviewed the company's plans for a pivotal phase 3 trial of urcosimod for neuropathic corneal pain, a chronic and often debilitating eye condition that currently has no specifically approved therapies. The trial, dubbed NEPTUNE (Neuropathic Eye Pain Treatment with Urcosimod & Nerve Evaluation), is set to kick off later this year.
Urcosimod is a lipid-conjugated chemerin peptide agonist with a dual mechanism — it targets immune cells driving ocular inflammation and also acts on neurons and glial cells in the dorsal root ganglion. The drug previously received FDA fast track designation and was approved for compassionate use in a single patient in January 2026. Okyo also plans to seek FDA breakthrough designation.
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Why it matters: Neuropathic corneal pain is notoriously difficult to treat, leaving patients with persistent, often severe discomfort and few options. A successful NEPTUNE trial could bring the first specifically approved therapy to this underserved patient population.
