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OKYO Pharma to Release New and Comprehensive Data from Phase 2 Dry Eye Disease Trial and Host Key Opinion Leader Event -Phase 2 OK-101 efficacy data to be released

Key Takeaway: OKYO Pharma Limited announced the upcoming release of new efficacy data from its Phase 2 trial of OK-101 for dry eye disease, set for March 22, 2024. The trial demonstrated promising results with significant drug effects observed as early as 15 days post-dosing. Additionally, the company will host a Key Opinion Leader event to discuss the findings in detail. Plans for advancing OK-101 into Phase 3 clinical trials are also in place, targeting both dry eye disease and neuropathic corneal pain.

Market Sentiment Analysis

POSITIVE FACTORS

  • Upcoming release of comprehensive efficacy data from Phase 2 trial.
  • Statistically significant effects noted in preliminary data after 15 days.
  • Planned advancement to Phase 3 clinical trials in 2024.
  • Focus on addressing unmet needs in dry eye disease and neuropathic corneal pain.

Full Press Release Details

Pharma to Release New and Comprehensive Data from Phase 2 Dry Eye Disease Trial and Host Key Opinion Leader Event
2 OK-101 efficacy data to be released March 22, 2024-
and New York, NY, March 20, 2024 - OKYO Pharma Limited (NASDAQ: OKYO), a clinical-stage biopharmaceutical
company developing innovative ocular therapies for the treatment of inflammatory dry eye disease (DED), amulti-billion-dollar market,
and anterior ocular segment diseases including neuropathic corneal pain (NCP), an ocular condition associated with pain but without an
FDA approved therapy, announces that it will be releasing new and comprehensive efficacy data readout from the Phase 2 trial of
OK-101 in dry eye disease on March 22, 2024. The company will also host a Key Opinion Leader (KOL) event to discuss the findings in depth.
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
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.
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 Gary S. Jacob, Ph.D., CEO of OKYO Pharma.
"We plan to advance OK-101 into Phase 3 clinical trials in 2024, with the goal of developing a highly differentiated dry eye product
to help patients underserved by current treatments. Our parallel development focus for OK-101 in 2024 is the evaluation of this drug
candidate to treat neuropathic corneal pain for which we have already received IND clearance to begin clinical studies."
Phase 2 Trial in DED Patients
double-masked, randomized, placebo-controlled Phase 2 trial was conducted at six sites in the U.S. and enrolled 240 subjects with DED
dosed twice-daily (BID). Patients were randomly divided into 3 cohorts, with one of the cohorts dosed with 0.05% OK-101 (n=81), a second
with 0.1% OK-101 (n=80), and the third cohort with vehicle (n=79). The duration of a patient's treatment was 14 weeks, including
a 2-week run-in period on placebo, to exclude placebo responders from the study, followed by 12 weeks in the randomized portion of the
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.
Pharma Limited (NASDAQ: OKYO) is a clinical stage biopharmaceutical company developing innovative therapies for the treatment of DED
and NCP, with ordinary shares listed for trading on the NASDAQ Capital Market. OKYO is focused on the discovery and development of novel
molecules to treat inflammatory DED and ocular pain. In addition to the recently completed Phase 2 DED trial, OKYO also has plans underway
for the opening of a Phase 2 trial for OK-101 to treat NCP in patients with this debilitating condition. For further information, please
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.
OKYO Pharma Limited Gary S. Jacob, Chief Executive Officer 917-497-7560
Business Development & Investor Relations Paul Spencer +44 (0)20 7495 2379

Frequently Asked Questions

When will OKYO Pharma release new efficacy data for OK-101?

OKYO Pharma will release comprehensive efficacy data on March 22, 2024.

What condition is OK-101 targeting in its Phase 2 trial?

OK-101 targets dry eye disease (DED) in its Phase 2 clinical trial.

How many subjects were enrolled in the Phase 2 trial?

The Phase 2 trial enrolled 240 subjects with dry eye disease.

What is the goal for OK-101 following the Phase 2 trial?

The goal is to advance OK-101 into Phase 3 trials to help underserved patients.

What new trial is OKYO Pharma planning for 2024?

OKYO Pharma plans to begin a trial for OK-101 to treat neuropathic corneal pain.

Last updated: Mar 22, 2024