FDA Grants Neuropathic Corneal Pain IND

The FDA granted an Investigational New Drug (IND) application to OK-101 (OKYO Pharma Ltd.) for the treatment of neuropathic corneal pain (NCP), an ocular condition associated with pain but without an FDA-approved therapy. 
While the initial IND submission proposed an open-label design for the clinical trial, following positive feedback from the FDA, the phase 2 study is now designed as a double-masked, randomized, 12-week, placebo-controlled trial comparing OK-101 with placebo in NCP patients. 

A total of 54 patients are planned for the study, with NCP disease confirmed via confocal microscopy. The primary end point will be measured utilizing visual analog pain relief scores. These protocol changes will enable a statistically valid demonstration of a true drug effect of OK-101 on NCP symptoms, according to the company.  

The OK-101 trial, designed as a single-center trial, will be led by Pedram Hamrah, MD, of Tufts Medical Center, in Boston, as the principal investigator. 

“I am very pleased that we have gained FDA IND clearance for the first drug to be tested for NCP, a debilitating disease,” Hamrah said. “Receiving the IND clearance in an important and novel indication was not a trivial hurdle to overcome. Now that the path has been opened for drugs to be tested in NCP.”

OK-101 has been shown to produce anti-inflammatory and pain-reducing activities in mouse models of dry eye disease and NCP.
The initial trial of OK-101 is planned to begin in the second quarter of 2024.

Based on a press release from OKYO.