OKYO Pharma Ltd (NASDAQ:OKYO) is uniquely positioned to emerge as a key player in the ocular treatment arena as it advances its lead therapeutic candidate OK-101, analysts at Goldman Small Cap Research believe.
The company is focused on developing OK-101 to treat neuropathic corneal pain (NCP), which has no Food and Drug Administration (FDA)-approved treatment. In October 2024 the company commenced a Phase 2 trial of OK-101 in NCP, with results expected by the year-end.
"OKYO is the first company to be granted an investigational new drug (IND) application for NCP by the FDA for clinical trials in NCP patients, and the first company to launch a clinical trial in NCP patients specifically diagnosed with NCP,” analysts highlighted.
“This trial is on the heels of a favorable dry eye disease (DED) Phase 2 trial of OK-101 which notably demonstrated statistical significance in an ocular pain secondary endpoint.”
Analysts believe if OKYO Pharma wins an Orphan Drug Designation from the FDA for NCP, it could lead to a multi-billion dollar market opportunity for the company.
"Based on our estimates, the potential size of the NCP market assuming NCP receives Orphan Drug designation, is $6.4 billion,” they wrote. "The market opportunity for the first drug to receive FDA approval to treat this major unmet medical need is based on a 160,000 US potential patient size."
The firm could attract a potential joint venture development partner or be acquired in 2026 or 2027, analysts added.
They awarded the stock a 12-month price target of $5, almost five times the company’s share price at the time of writing.
“We believe that a series of milestones in 2025 followed by results from this trial serve as major catalysts for a re-valuation of these shares,” they wrote. “Our 12-month piece target is based on the prospective value of OK-101, projected sales multiples, and the median valuation of ocular biopharma M&A transactions."