AwesomeStocks Hello! New Alert: OKYO Pharma Limited (NASDAQ: OKYO) OKYO is our new NASDAQ high volatility alert with big news this morning. OKYO is a NASDAQ listed âophthalmology-focused bio-pharmaceutical companyâ. OKYO is âfocusing on the discovery and development of novel molecules to treat inflammatory dry eye diseases and chronic painâ. OKYO is âdeveloping OK-101 to treat dry eye disease (âDEDâ) to address the significant unmet need in this multi-billion-dollar marketâ. The companyâs âimmediate goal is to overcome the limitations of current dry eye treatments with the development of a first-in-class drug that combines both anti-inflammatory and pain reducing activityâ. As the company further explains: âOK-101 has been shown to produce anti-inflammatory and pain-reducing activities in mouse models of dry eye disease and NCP; and is designed to combat washout through the inclusion of the lipid âanchorâ contained in the candidate drug molecule to enhance the residence time of OK-101 within the ocular environment.â Dry eye disease is a âcommon condition that occurs when oneâs tears are unable to adequately lubricate the eyesâ. As the company explains: âThis condition affects approximately 49 million people in the U.S. alone and has been a difficult one to positively diagnose and to treat due to the multifactorial nature of the condition.â Furthermore: âTear film instability typically leads to inflammation and damage to the ocular surface.â It is often a chronic problem, particularly in older adults, and is expected to become even more prevalent with the aging population and increased use of digital screens such as computers and smart phones. Despite new product approvals, dry eye disease remains a significant unmet medical need and is one of the âleading causes for patient visits to eye care specialistsâ. According to the company, âworldwide, ~700 million patients suffer from dry eye diseaseâ. Sadly, âDry Eye affects over 35% of the population aged 50+, with women representing approximately two-thirds of those affectedâ. In December, OKYO announced: - âOKYO Pharma Announces U.S. FDA Clearance of IND Application for OK-101 for the Treatment of Dry Eye Diseaseâ Since then, the company has announced multiple accomplishments. As the company explains in its August 15 press release, here are the â2023 Developments Related to OK-101â: In April: - âOKYO announced the activation of the first clinical trial site in the U.S. for its phase 2, multi-center, randomized, double-blinded, placebo-controlled trial, evaluating the efficacy and safety of OK-101 ophthalmic solution in subjects with DED.â In May: - âOKYO announced that the first patient has been screened for its phase 2, multi-center, randomized, doubleâblinded, placebo-controlled trial, evaluating the efficacy and safety of OK-101 ophthalmic solution in subjects with DED.â
- âOKYO announced that two presentations were to be given on OK-101 at the American Society of Cataract and Refractive Surgery (ASCRS 2023) in San Diego, CA, May 5-8, 2023.â In June: - âOKYO announced that patients were now being dosed in the randomized portion of the phase 2, multi-center, double-masked, placebo-controlled trial of topical ocular OK-101 to treat DED, following the two-week placebo run-in period intended to minimize the placebo effect.â In July: - âOKYO announced a new agreement with Tufts Medical Center to conduct a 40-patient open-label clinical trial evaluating the efficacy and safety of OK-101 in patients with neuropathic corneal pain (âNCPâ). The Investigational New Drug (âINDâ) application for NCP is planned to be filed in Q4 of 2023, with study enrollment planned to commence shortly after IND allowance by the FDA.â Most recently, the company announced: âOKYO Pharma Limited Reports Annual Results for the Twelve Months Ended March 31, 2023â Here are the companyâs comments from this press release: âGary Jacob, Chief Executive Officer of OKYO, commented, âWe are very pleased at the advancements we have made with our flagship drug OK-101 to treat DED this year. On May 2, 2023, we announced the initiation of our first clinical trial of OK-101 to treat DED. This trial is a 240 patient, phase 2, multi-center, randomized, double-masked, placebo-controlled trial in patients with DED. This summer we are expecting to see considerable enrollment of patients in the ongoing trial and are presently on track to have top line data released in Q4 2023. I am also excited about OK-101âs dual combination of anti-inflammatory ocular activity and neuropathic corneal pain (NCP) reducing activity. NCP is a debilitating condition characterized by chronic and severe eye discomfort, leading to decreased quality of life for affected individuals. There is presently no FDA approved drug to treat NCP and we were pleased to recently announce our plan to open a small trial of OK-101 to treat patients with NCP at Tufts Medical Center in Boston. We remain steadfast in our dedication to advancing groundbreaking ocular solutions that have the potential to transform patients' lives. Our team's resilience and unwavering focus on research and development will continue to be the driving force behind our progress. We are actively exploring opportunities to optimize our operational efficiency and enhance our partnerships within the industry. Thank you to our employees, partners, and shareholders for their continued support as we work diligently to bring about a new treatment to benefit the many millions of patients suffering from DED."â In addition, the company announced breaking news this morning: - âOKYO Pharma Limited Regains Compliance with Nasdaq Listing Minimum Market Value Ruleâ OKYO could be in a position to experience increased growth. Make sure to do your own due diligence. Sources: [Presentation]( [PR1]( [PR2]( [PR3]( [PR4]( [PR5]( [PR6]( [PR7]( [PR8]( [Website]( [Chart]( Happy Trading! AwesomeStocks Note: We encourage all traders and investors to develop personal trading rules that you can follow and that work for you. Always protect your downside and note that we alert extremely volatile short-term opportunities. Before investing in securities, you should always consult with your financial, tax and legal advisor and never invest money you cannot afford to lose. 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