OKYO Pharma Ltd. operates as a biopharmaceutical company, which engages in the development of therapeutics for inflammatory eye diseases and chronic pain. It operates through the US and UK geographical segments. The company was founded on July 4, 2007 and is headquartered in London, the United Kingdom.
Clinical Trials
2
0 active
Approvals
0
Total approvals
Agencies
0
Regulatory bodies
Founded
N/A
Completed
1
50.0%
Terminated
1
50.0%
No approval data available
- OKYO Pharma received positive feedback from an FDA Type D meeting, validating the regulatory and clinical path forward for urcosimod in neuropathic corneal pain (NCP). - The NEPTUNE Phase 3 pivotal trial will enroll approximately 111 subjects in a 2:1 randomization of 0.05% urcosimod versus placebo across the United States and Europe. - Urcosimod is the first investigational therapy with an open IND specifically for NCP, a debilitating condition with no currently FDA-approved therapies. - The company plans to seek FDA Breakthrough Therapy Designation, which may further accelerate the development and review pathway for this potential first-in-class, non-opioid treatment.
- OKYO Pharma has appointed Robert J. Dempsey as Chief Executive Officer, bringing over two decades of ophthalmology commercialization experience including leadership of blockbuster dry eye therapies Xiidra® and Restasis®. - Dempsey previously led the $3.4 billion upfront sale of Xiidra® to Novartis in 2019, one of only three ophthalmology deals in the past twenty years exceeding $1 billion upfront. - The leadership transition positions OKYO to advance urcosimod, its lead asset for neuropathic corneal pain, a severe ocular condition currently without FDA-approved therapy. - OKYO recently completed a successful Phase 2 trial of urcosimod in neuropathic corneal pain patients and plans to initiate a larger multicenter trial in Q1 2026.
- OKYO Pharma has received $1.9 million in non-dilutive funding to support its pharmaceutical development programs. - The company has achieved promising Phase 2 trial results that have contributed to positive analyst ratings. - FDA has granted Fast Track designation to one of OKYO Pharma's therapeutic candidates, expediting regulatory review. - The combination of funding, clinical progress, and regulatory recognition positions the company for accelerated development.
- OKYO Pharma's Phase 2 trial for urcosimod, a potential first-in-class treatment for neuropathic corneal pain, closed early after treating 17 patients instead of the planned 48, with top-line results now expected in Q3 2025. - Goldman Small Cap Research raised its price target for OKYO shares to $8 from $5, citing the early trial closure as potentially shortening the development pathway and accelerating time to market. - The drug targets neuropathic corneal pain, a debilitating condition with no FDA-approved therapies and an estimated market opportunity exceeding $6.4 billion. - OKYO's shares have nearly doubled since the start of 2025, driven by clinical progress and the FDA's Fast Track designation for urcosimod.
- OKYO Pharma expects to complete enrollment of 48 patients in its Phase 2a trial of OK-101, the first FDA-cleared investigational drug specifically for neuropathic corneal pain, by Q2 2025. - The company recently reported positive Phase 2b results for OK-101 in dry eye disease, showing significant improvements in conjunctival staining and symptom reduction with a favorable safety profile. - The Phase 2a NCP trial, led by renowned expert Dr. Pedram Hamrah at Tufts Medical Center, is designed as a double-masked, randomized, 12-week placebo-controlled study.
- OKYO Pharma has dosed the first subject in its Phase II clinical trial of OK-101 for neuropathic corneal pain (NCP). - The trial is a double-masked, randomized, placebo-controlled study involving 48 patients diagnosed with NCP, confirmed via confocal microscopy. - OK-101, a lipid-conjugated chemerin peptide agonist, targets the ChemR23 receptor on immune cells, aiming to reduce inflammation associated with corneal nerve damage. - There are currently no FDA-approved treatments for NCP, making OK-101 a potential breakthrough therapy for this chronic condition.
- OKYO Pharma has dosed the first patient in its Phase 2 clinical trial evaluating OK-101 for the treatment of neuropathic corneal pain (NCP). - The Phase 2 trial is a randomized, double-masked, placebo-controlled study aiming to enroll 48 patients with confirmed NCP. - OK-101 is a non-opioid therapeutic candidate designed to alleviate pain associated with corneal nerve damage, addressing an unmet need. - The trial's primary endpoint is to measure pain relief using the Visual Analog Scale (VAS).
