In a previous preliminary data readout, OK-101 showed statistically significant drug effects in FDA-recognized efficacy endpoints as early as the 15-day first visit after dosing. Additionally, statistically significant improvements were observed in both a “sign” (total conjunctival staining) and two “symptoms” (burning/stinging and blurred vision), which are FDA-recognized endpoints of dry eye disease.
The KOL call will feature prominent experts in the field of dry eye disease. The speakers will provide insights regarding the clinical significance of the OK-101 Phase 2 findings and discuss the potential implications for patient care and future research endeavors in DED.
“The upcoming data release follows the successful completion of OKYO Pharma's Phase 2 trial, which focused on assessing the efficacy and safety of OK-101, our novel topical therapeutic candidate for dry eye disease,” said
OK-101 Phase 2 Trial in DED Patients
The double-masked, randomized, placebo-controlled Phase 2 trial was conducted at six sites in the
About OK-101
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 was developed using a membrane-anchored-peptide technology to produce a novel long-acting drug candidate for treating dry eye disease. OK-101 has been shown to produce anti-inflammatory and pain-reducing efficacy signals in mouse models of dry eye disease and corneal neuropathic pain (NCP), respectively, and is designed to combat washout through the inclusion of the lipid anchor built into the drug molecule to enhance the residence time of OK-101 within the ocular environment. OK-101 recently showed statistical significance in multiple endpoints in a recently completed Phase 2, multi-center, double-blind, placebo-controlled trial of OK-101 to treat DED.
About OKYO
Forward-Looking Statements
Certain statements made in this announcement are forward-looking statements, including with respect to the anticipated timing of completion of enrolment of the Company’s Phase 2 trial of topical ocular OK-101 to treat DED and the release of top-line data therefrom. These forward-looking statements are not historical facts but rather are based on the Company’s current expectations, estimates, and projections about its industry, its beliefs, and assumptions. Words such as ‘anticipates,’ ‘expects,’ ‘intends,’ ‘plans,’ ‘believes,’ ‘seeks,’ ‘estimates,’ and similar expressions are intended to identify forward-looking statements. These statements are not guarantees of future performance and are subject to known and unknown risks, uncertainties, and other factors, some of which are beyond the Company’s control, are difficult to predict, and could cause actual results to differ materially from those expressed or forecasted in the forward-looking statements. The Company cautions security holders and prospective security holders not to place undue reliance on these forward-looking statements, which reflect the view of the Company only as of the date of this announcement. The forward-looking statements made in this announcement relate only to events as of the date on which the statements are made. The Company will not undertake any obligation to release publicly any revisions or updates to these forward-looking statements to reflect events, circumstances, or unanticipated events occurring after the date of this announcement except as required by law or by any appropriate regulatory authority.
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