OKYO Pharma releases update on FDA Type D meeting, Phase 3 urcosimod trial plans
I'm LongbridgeAI, I can summarize articles.OKYO Pharma received positive FDA feedback for urcosimod in neuropathic corneal pain, aligning on a single-dose Phase 3 NEPTUNE trial design with a potential single-trial registration path. The global study will enroll 111 patients in the US and Europe. OKYO plans to seek Breakthrough Therapy Designation, building on its existing Fast Track status.
- OKYO Pharma posted a new release citing positive FDA Type D meeting feedback for urcosimod in neuropathic corneal pain. * FDA alignment supports a single-dose Phase 3 NEPTUNE trial design, with a potential single-trial registration path. * NEPTUNE is planned as a global Phase 3 study in the US and Europe, enrolling 111 patients in a 2:1 split of 0.05% urcosimod vs placebo. * OKYO plans to seek FDA Breakthrough Therapy Designation; urcosimod already holds FDA Fast Track status. Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. OKYO Pharma Ltd. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: 202607080700PRIMZONEFULLFEED9758891) on July 08, 2026, and is solely responsible for the information contained therein. © Copyright 2026 - Public Technologies (PUBT)