FDA clears first investigational new drug application for neuropathic corneal pain
Key takeaways:
- This is the first clearance of an investigational new drug application for neuropathic corneal pain.
- A phase 2 trial comparing OK-101 and placebo is planned to begin in the second quarter.
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 recently demonstrated favorable tolerability in a phase 2 trial of dry eye patients along with statistically significant improvements in dry eye symptoms such as stinging/burning and blurred vision, which are also hallmarks of NCP. OK-101 was also shown in a cutting-edge mouse model of NCP to significantly reduce ocular neuropathic pain,” Gary S. Jacob, PhD, CEO of Okyo, said in the release. “We are looking forward to advancing OK-101 to potentially treat NCP, a chronically painful ocular disease with no FDA-approved therapy and a major unmet medical need for patients suffering from this condition.”