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January 23, 2026
1 min read
FDA Authorizes Compassionate Use of Urcosimod for Severe Corneal Pain
A new treatment option is being explored for patients with neuropathic corneal pain, a condition with limited FDA-approved therapies.
- Urcosimod 0.05% has received FDA authorization for compassionate use in a single patient suffering from neuropathic corneal pain.
- The medication will be provided through an expanded access IND application.
- A phase 2b/3 clinical trial evaluating urcosimod is planned for later this year.
The Food and Drug Administration has authorized the use of urcosimod 0.05% under expanded access, often referred to as compassionate use, for a patient grappling with severe neuropathic corneal pain, according to a recent proclamation from Okyo.
Under the terms of the Investigational New Drug (IND) application, Okyo will supply urcosimod for use in a patient who has weary other treatment options and currently has no FDA-approved alternatives.
Source: Healio
“This authorization represents an important step in our commitment to providing potential treatment options for patients with serious and life-altering conditions,” said Hiroki Okyo, CEO of Okyo, in the announcement. “We are pleased to work with the FDA to make urcosimod available to this patient in need.”
Urcosimod is a lipid conjugated chemerin peptide agonist of the ChemR23 G-protein coupled receptor. This protein receptor is found in immune cells within the eye and can contribute to inflammatory responses.
A prior randomized, placebo-controlled, double-masked phase 2 study of
