FDA Endorses OKYO Pharma’s 12-Week VAS Endpoint; Analysts Set $5-13 Targets
FDA endorsed OKYO Pharma’s Phase 2b/3 urcosimod trial design, approving a 12-week VAS pain score primary endpoint and OPAS quality-of-life measure. Three analysts sustained Buy ratings with $13, $7 and $5 price targets as a 120-patient Phase 2b study begins in Q1 2026.
1. FDA Meeting Outcomes
The FDA provided feedback at a Type C meeting endorsing OKYO Pharma’s proposed Phase 2b/3 urcosimod trial for neuropathic corneal pain, approving the 12-week Visual Analogue Scale (VAS) pain score as the primary endpoint and supporting the Ocular Pain Assessment Survey (OPAS) quality-of-life measure, with no issues raised on the CMC strategy.
2. Analyst Ratings and Targets
Analysts at Lucid Capital, H.C. Wainwright and B. Riley Securities each maintained Buy ratings, setting price targets of $13, $7 and $5 respectively, highlighting positive Phase 2 data and mechanistic imaging findings that suggest urcosimod’s potential to address unmet needs in neuropathic corneal pain.
3. Phase 2b Trial Plans
OKYO Pharma plans to initiate a multiple ascending dose Phase 2b study enrolling 120 patients in Q1 2026, evaluating 0.025% and 0.05% urcosimod against placebo over 12 weeks, with topline results expected by year-end 2026.