OKYO Pharma Limited (NASDAQ: OKYO) announced yesterday that its lead drug candidate, OK-101, has officially been assigned the United States Adopted Name (USAN) “urcosimod.” This designation marks a significant milestone in the company’s ongoing development of novel treatments for neuropathic corneal pain (NCP) and dry eye disease (DED), two conditions with significant unmet medical needs.
Urcosimod, a lipid-conjugated small molecule, is currently undergoing Phase 2 clinical trials targeting NCP, a severe ocular condition with no FDA-approved treatment. The drug has also shown promising results in a previous Phase 2 trial for DED, an indication with a multi-billion-dollar market potential.
The USAN designation reflects the drug’s innovative mechanism of action, as urcosimod is designed to target ocular G-protein coupled receptors (GPCRs), modulating both inflammatory and neuropathic pain pathways. The suffix “-mod” in urcosimod signifies its function as a modulator, offering a dual benefit of anti-inflammatory and pain-relieving properties.
“This is a pivotal moment in the development of urcosimod, underscoring our commitment to advancing novel therapies for serious ocular conditions,” said Dr. Gary S. Jacob, CEO of OKYO Pharma. “Neuropathic corneal pain is a debilitating condition for which there are no FDA-approved therapies, and we believe urcosimod’s dual-action mechanism positions it uniquely to address the underlying causes and symptoms of both NCP and DED.”
OKYO Pharma initiated its Phase 2 trial for NCP in October 2024, with top-line results expected by Q4 2025. Previous Phase 2 trial data for DED showed significant pain-reducing effects, which could indicate similar potential efficacy in NCP due to the overlap in pain modulation mechanisms.
The strategic USAN assignment comes at a crucial time in OKYO’s clinical development program, potentially accelerating future regulatory submissions and enhancing the drug’s commercialization prospects. Urcosimod’s platform technology, which combines anti-inflammatory and analgesic properties into one molecule, sets it apart from traditional ocular disease treatments and could offer improved patient outcomes.
The ongoing Phase 2 trials are pivotal to determining urcosimod’s ability to meet the needs of patients suffering from these chronic conditions. Given the absence of FDA-approved treatments for NCP, the success of urcosimod in this space could give OKYO a first-mover advantage, with potential for substantial market exclusivity.
About OKYO Pharma
OKYO Pharma Limited is a clinical-stage biopharmaceutical company focused on the discovery and development of novel therapies for NCP and DED. The company’s lead asset, urcosimod, is currently in Phase 2 trials for both conditions. With a focus on innovative treatments for ocular diseases, OKYO is committed to addressing significant unmet medical needs in the ophthalmology space.
About Neuropathic Corneal Pain (NCP)
NCP is a severe, often debilitating condition that causes significant pain and sensitivity in the eyes, face, and head. The exact cause of NCP is thought to be a combination of nerve damage to the cornea and inflammation. Currently, there are no FDA-approved therapies for NCP, and patients often rely on off-label treatments.
About Urcosimod
Urcosimod (formerly known as OK-101) is a lipid-conjugated small molecule designed to target the ChemR23 GPCR, involved in regulating inflammation and pain. It has demonstrated both anti-inflammatory and pain-reducing effects in preclinical models of DED and NCP. Urcosimod is currently being evaluated in Phase 2 trials for both conditions.
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