OKYO Pharma secures positive FDA alignment for Phase 3 trial

• OKYO Pharma received positive FDA Type D feedback to advance its pipeline asset urcosimod into a global Phase 3 study.
• The regulatory alignment supports a single-dose study design and a potential single-trial registration pathway for the drug.
• The upcoming pivotal evaluation targets enrolling approximately 111 patients across the United States and Europe.

OKYO Pharma (NASDAQ:OKYO) received positive regulatory feedback from the United States Food and Drug Administration following a Type D consultation to advance its ophthalmic candidate urcosimod into a global Phase 3 pivotal trial.

The federal regulatory alignment supports a single-dose study design and establishes a potential single-trial registration pathway to treat patients suffering from debilitating neuropathic corneal pain.

"This Type D meeting feedback provides a clear and accelerated regulatory path forward for urcosimod, optimizing our clinical timeline for this underserved patient population," said OKYO Pharma Chief Executive Officer Dr. Gary S. Jacob.

The upcoming pivotal evaluation, designated as the NEPTUNE trial, intends to randomize approximately 111 participants in a 2:1 ratio comparing a 0.05% concentration of the active drug against a matching placebo.

Following the announcement, OKYO Pharma's share price was up at $1.68.

The biopharmaceutical company intends to leverage its open Investigational New Drug status to formally request Breakthrough Therapy Designation from federal regulators to further accelerate commercial development.

The investigational therapeutic lipid molecule is engineered as a topical formulation to target specialized neuro-inflammatory pathways to alleviate chronic ocular pain without causing systemic side effects.