OKYO Pharma Announces Start of Phase 2 Trial For Neuropathic Corneal Pain

OKYO Pharma Limited, a company in the clinical stage of biopharmaceutical development, is creating new treatments for inflammatory dry eye disease (DED) and neuropathic corneal pain (NCP). This billion-dollar market lacks FDA-approved therapy for NCP. Screening and patient recruitment have begun for a Phase 2 trial of OK-101 to treat NCP.

The Phase 2 trial for NCP patients is set up as a 12-week placebo-controlled study with a double-blind, randomized design. A study will enroll a total of 48 patients diagnosed with NCP disease using confocal microscopy. The main objective of this study is to assess pain alleviation through the Visual Analog Scale (VAS) tool.

There are currently no treatments on the market approved for neuropathic corneal pain, which remains a medical need that has yet to be addressed. NCP is a state that results in discomfort and heightened sensitivity in the eyes, face, or head. The precise reason for NCP is not known but is believed to be due to nerve damage to the cornea along with inflammation. NCP, a condition that can manifest as severe, chronic, or debilitating in patients with a variety of eye conditions, is currently managed through different topical and systemic treatments that are not approved for this specific use.

In a Phase clinical 2 trial with dry eye patients, OK-101 showed positive safety and tolerability and also led to significant improvements in symptoms like stinging/burning and ocular pain, which are common in NCP. OK-101 was also demonstrated to effectively decrease neuropathic corneal pain in a state-of-the-art mouse model of NCP.