OKYO Pharma Limited announced the first patient has been dosed in the Phase 2 trial of topical ocular OK-101 to treat NCP. The Phase 2 study is designed as a double-masked, randomized, 12-week placebo-controlled trial in NCP patients. A total of 48 patients are planned to enroll, with NCP disease confirmed via confocal microscopy, the company said in a press release. 

OK-101, a novel, non-opioid therapeutic candidate, is designed to target and alleviate the debilitating pain associated with corneal nerve damage, a condition for which there are currently no FDA-approved treatments, the company said.

The OK-101 trial is designed as a single-center trial and is being led by Pedram Hamrah, MD, of Tufts Medical Center, as principal investigator. Dr. Hamrah is Professor and Vice Chair of Research and Academic Programs, and Director of the Center for Translational Ocular Immunology at Tufts Medical Center. His previous research has demonstrated safety and efficacy of various topical and systemic treatments for ocular pain and has led to the development of new diagnostic markers for ocular pain by in vivo confocal microscopy, the company said.

In addition to his work on OK-101, of which he is a co-inventor and member of OKYO’s Scientific Advisory Board, Dr. Hamrah is conducting studies on developing new corneal nerve function tests and plans to launch a new center of excellence for ocular pain and ocular surface disease at Tufts Medical Center, said the company.

“Enrolling the first patient in this clinical trial is an important first step towards our goal of determining the safety and efficacy of OK-101 for the treatment of NCP,” said Dr. Hamrah. “There is a significant, unmet need for an approved therapy to help mitigate eye pain in patients with NCP around the world. We look forward to continuing to advance recruitment in the coming weeks and months, and to rigorously evaluate this experimental therapy in this patient population.”