OKYO Pharma Limited (OKYO), a clinical-stage biopharmaceutical company, on Wednesday announced the initiation of its Phase 2a clinical trial for OK-101, a novel non-opioid therapeutic candidate aimed at treating neuropathic corneal pain or NCP.
The company anticipates completing enrollment of 48 patients by the end of the second quarter of 2025, with top-line data expected in the fourth quarter of 2025.
The trial is designed to evaluate the safety, efficacy, and tolerability of OK-101 in patients with NCP, a severe ocular condition for which no FDA-approved therapies currently exist.
OK-101 works by targeting corneal nerve damage, a key cause of the debilitating pain associated with NCP.
The trial is being led by Dr. Pedram Hamrah of Tufts Medical Center, a recognized expert in NCP.
OKYO also highlighted its continued progress in the treatment of dry eye disease or DED, with positive results from the Phase 2b trial of OK-101 for DED, showing significant improvements in patient symptoms.
For the six months ending September 30, 2024, the company reported a total comprehensive loss of $3.1 million for the period, a decrease from the $8.5 million loss in the same period of 2023.
OKYO reported total assets of $2.8 million, up from $1.5 million as of March 31, 2024.
The company had cash on hand of $1.0 million as of September 30, 2024, post-period, OKYO secured an additional $1.8 million in funding.
The company is optimistic about the potential of OK-101 to provide long-term relief for patients with both NCP and DED and is working closely with the FDA regarding future clinical plans for OK-101 in DED.
Currently, OKYO is trading at $1.15 up by 11.52%.
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