The FDA cleared an investigational new drug application for OK-101 for the treatment of neuropathic corneal pain, according to a press release from Okyo Pharma.
This is the first clearance of an investigational new drug (IND) application for a neuropathic corneal pain (NCP) treatment.
Based on positive feedback from the FDA, Okyo plans to enroll 54 patients with NCP in a phase 2 double-masked, randomized 12-week trial comparing OK-101 against placebo. Visual analogue scale pain relief scores will be used to measure the primary endpoint. The trial is expected to begin in the second quarter.
“OK-101