OKYO Pharma Gets FDA Alignment on 111-Subject Phase 3 Urcosimod Trial Design
OKYO•OKYO Pharma secured FDA validation of its single-dose Phase 3 NEPTUNE trial design, planning 111-subject enrollment with 2:1 randomization of 0.05% urcosimod versus placebo. The company aims for a single-trial registration pathway and will seek Breakthrough Therapy Designation to fast-track its first-in-class neuropathic corneal pain therapy.
1. FDA Type D Meeting Outcome
OKYO Pharma received positive feedback from the FDA during its Type D meeting, validating the regulatory and clinical path for urcosimod. This milestone reduces program risk by confirming a single-dose pivotal study design and a potential single-trial registration pathway.
2. NEPTUNE Phase 3 Trial Design
The NEPTUNE trial will enroll approximately 111 patients across the United States and Europe, randomizing subjects 2:1 to receive a 0.05% urcosimod dose or placebo. This design targets robust efficacy and safety data to support future marketing approval.
3. Regulatory Strategy and Next Steps
OKYO plans to pursue Breakthrough Therapy Designation to accelerate review and development timelines. The company aims to initiate the global Phase 3 NEPTUNE trial in the second half of the year, leveraging its strong balance sheet to support rapid execution.
