Okyo Pharma Files Investigational NDA to Develop OK-101 for DED

Okyo Pharma Files Investigational NDA to Develop OK-101 for DED

November 24, 2022

Okyo Pharma filed an investigational new drug application (NDA) with the FDA for the development of OK-101 to treat dry eye disease (DED).

In a previous pre-IND meeting organized by Okyo's contract research firm, Ora, the FDA reviewed both the nonclinical and clinical development plans for OK-101, and the FDA approved a first-in-human phase 2 trial in DED patients.

The FDA also approved Okyo's proposals to include primary and secondary effectiveness endpoints in the clinical protocol of the trial that would encompass both a sign and a symptom of DED.

“The filing of this IND with FDA is a key step for Okyo as we advance our plan to open a phase 2 trial in DED patients in the first quarter of 2023,” Gary S. Jacob, PhD, CEO of London-based Okyo Pharma, said in a company news release. “We were pleased with the clear guidance we received from the FDA pre-IND meeting earlier in the year. The fact that we are designating primary and secondary efficacy endpoints in this first-in-human trial is highly significant as should our upcoming trial of OK-101 meet its prespecified primary endpoint, it could accelerate the timeline to a new drug application (NDA) filing with the FDA.”

OK-101 is a lipid conjugated chemerin peptide agonist of the ChemR23 G-protein coupled receptor which is typically found on immune cells of the eye responsible for the inflammatory response. OK-101 has been shown to produce anti-inflammatory and neuropathic pain-reducing activities in mouse models of DED and corneal neuropathic pain, respectively, and is designed to combat washout through the inclusion of the lipid ‘anchor’ contained in the drug molecule to enhance the residence time of OK-101 within the ocular environment.