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OKYO Pharma Limited (NASDAQ: OKYO) is a clinical-stage biopharmaceutical company dedicated to developing groundbreaking therapies for inflammatory eye diseases and chronic pain conditions. The company is at the forefront of creating innovative treatments for Dry Eye Disease (DED) and Neuropathic Corneal Pain (NCP), both of which represent significant unmet medical needs in the ophthalmology sector.
One of OKYO Pharma's hallmark achievements is its development of the OK-101 ophthalmic solution. This drug candidate has shown promising results in pre-clinical studies, demonstrating dual-action anti-inflammatory and neuropathic corneal pain-reducing activities. The ongoing Phase 2 clinical trials are aimed at establishing the safety and efficacy of OK-101 in treating DED and NCP. Notably, these trials have successfully completed patient enrollment, with top-line results expected soon.
OKYO Pharma's approach leverages a unique membrane-anchored-peptide technology to ensure the prolonged presence of the drug in the ocular environment, thereby enhancing its therapeutic impact. In recent studies, OK-101 has exhibited statistically significant improvements in multiple dry eye-related symptoms, including stinging, burning, and blurred vision, as well as a notable reduction in conjunctival staining. These promising outcomes pave the way for future Phase 3 registration trials.
Financially, OKYO Pharma is well-positioned, with its ordinary shares listed on the NASDAQ Capital Market. The company continues to forge strategic partnerships and collaborations to bolster its research and development efforts. With a robust pipeline and a commitment to addressing the complex biology of eye diseases, OKYO Pharma stands as a pioneering entity in the biopharmaceutical landscape.
The latest developments include positive safety and efficacy results from the Phase 2 trials of OK-101, and the recent FDA clearance for OK-101's Investigational New Drug (IND) application for treating NCP. These milestones underscore the potential of OKYO Pharma's innovative solutions to significantly improve patient outcomes.
OKYO Pharma Limited has received FDA clearance to start a Phase 2 clinical trial for OK-101, a treatment for Dry Eye Disease (DED). This first-in-human study will assess both efficacy endpoints relating to the signs and symptoms of DED. The trial is set to begin in Q1 2023, aiming to demonstrate OK-101's potential as a novel treatment option for patients inadequately addressed by existing medications. The company emphasizes that success in this trial could expedite the filing for a new drug application (NDA) with the FDA.
OKYO Pharma Limited (LSE: OKYO; NASDAQ: OKYO) announced its participation in the Biotech Showcase in San Francisco from January 9-11, 2023. The company focuses on developing OK-101 to treat dry eye disease, addressing significant unmet needs in this multi-billion-dollar market. CEO Dr. Gary Jacob and other executives will present and hold 1x1 institutional investor meetings during the event. Attendees can schedule meetings online. The event highlights OKYO's commitment to innovation in treating inflammatory dry eye diseases.
OKYO Pharma Limited (LSE: OKYO; NASDAQ: OKYO) has filed a Form F-1 registration statement with the SEC for a secondary public offering of its American Depositary Shares (ADSs). Each ADS will represent 65 ordinary shares. The offering's size and price are yet to be determined and depend on market conditions. This offering, approved by shareholders at the September 2022 AGM, will allow OKYO's shares to continue trading on the LSE and NASDAQ. ThinkEquity is the sole bookrunning manager, and the offering will not be available in the EEA or UK to the public.
OKYO Pharma Limited (LSE: OKYO; NASDAQ: OKYO) appointed PKF Littlejohn LLP as its new independent auditor effective immediately. The board approved PKF for the financial year ending March 31, 2023, with re-appointment subject to shareholder approval at the next AGM in 2023. The previous auditor, Mazars LLP, confirmed no matters for the Company’s members or creditors. OKYO thanks Mazars for their service. This announcement contains inside information under UK market regulations.
OKYO Pharma Limited (LSE: OKYO; NASDAQ: OKYO) has awarded Chief Scientific Officer Raj Patil 5,000,000 options with an exercise price of 6.25 pence per share, recognizing his contribution to the recent IND filing for OK-101, aimed at treating dry eye disease. The options vest immediately and have a five-year lifespan. This move highlights the company's advancement in developing therapies for the significant unmet needs in the dry eye market, which is valued in the billions. The announcement complies with UK MAR regulations.
OKYO Pharma Ltd (NASDAQ: OKYO) announced a Key Opinion Leader webinar on November 14, 2022, regarding its potential treatment, OK-101, for inflammatory dry eye disease. The event features KOL Pedram Hamrah, MD, discussing preclinical data on OK-101's efficacy. The company aims to address a significant market need in dry eye therapies and will provide updates on its Phase 2 trial for OK-101, a lipid-conjugated peptide targeting ocular pain and inflammation.
OKYO Pharma Limited (NASDAQ: OKYO) announced its CEO, Dr. Gary Jacob, will be featured on The RedChip Money Report on Bloomberg TV on September 10, 2022. The interview will cover the company's NASDAQ listing, plans for a Phase 2 study for Dry Eye Disease, and expectations for top-line data. This access expands OKYO's visibility as it operates in the biotechnology sector, focusing on new treatments for inflammatory dry eye diseases and ocular pain.
OKYO Pharma Limited (NASDAQ: OKYO) announced an upcoming interview with CEO Dr. Gary Jacob on the RedChip Money Report airing on Bloomberg TV on September 10, 2022, at 7 p.m. ET. The interview will cover the company's NASDAQ listing and plans for a Phase 2 study for Dry Eye Disease, including anticipated top-line data. OKYO focuses on developing novel treatments for inflammatory dry eye diseases and chronic pain, and is listed on both NASDAQ and the London Stock Exchange.
On September 7, 2022, OKYO Pharma Limited (LSE: OKYO; NASDAQ: OKYO) announced that all resolutions at its Annual General Meeting were successfully passed. The voting results showed overwhelming support, with key resolutions such as the approval of the report and accounts receiving 99.99852% approval. Shareholders, totaling 1,415,040,468 ordinary shares, participated actively in the voting process. The resolutions included the re-election of directors and the appointment of auditors, reflecting strong governance practices and shareholder confidence in the company's direction.
OKYO Pharma Limited is gearing up for a Q4 2022 IND filing for OK-101, targeting dry eye disease (DED) and supported by AmbioPharm. Following a successful pre-IND meeting with the FDA in Q1 2022, the Phase 2 trial is set to commence in Q1 2023, designed to expedite market entry. OK-101, a lipid-peptide analog, showcases potent anti-inflammatory properties in animal models, addressing a significant unmet need in the multibillion-dollar DED market.
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