Shares of OKYO are on a tear as Wall Street awaits potential FDA approval for the companyâs game-changing first-in-class drug treatment.âÍ âÍ âÍ âÍ âÍ âÍ âÍ âÍ âÍ âÍ âÍ âÍ âÍ âÍ âÍ âÍ âÍ âÍ âÍ âÍ âÍ âÍ âÍ âÍ âÍ âÍ âÍ âÍ âÍ âÍ âÍ âÍ âÍ âÍ âÍ âÍ âÍ âÍ âÍ âÍ âÍ âÍ âÍ âÍ âÍ âÍ âÍ âÍ âÍ âÍ âÍ âÍ âÍ âÍ âÍ âÍ âÍ âÍ âÍ âÍ âÍ âÍ âÍ âÍ âÍ âÍ âÍ âÍ âÍ âÍ âÍ âÍ âÍ âÍ âÍ âÍ âÍ âÍ âÍ âÍ âÍ âÍ âÍ âÍ âÍ âÍ âÍ âÍ âÍ âÍ âÍ âÍ âÍ âÍ âÍ âÍ âÍ âÍ âÍ âÍ âÍ âÍ âÍ âÍ âÍ âÍ âÍ âÍ âÍ âÍ âÍ âÍ âÍ âÍ âÍ âÍ âÍ âÍ âÍ âÍ âÍ âÍ âÍ âÍ âÍ âÍ âÍ âÍ âÍ âÍ âÍ âÍ âÍ âÍ âÍ âÍ âÍ âÍ âÍ âÍ âÍ âÍ âÍ âÍ âÍ âÍ âÍ âÍ âÍ âÍ Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Shares of OKYO are on a tear as Wall Street awaits potential FDA approval for the companyâs game-changing first-in-class drug treatment. Greetings Investors, One sector that has massively benefited from the advances in technology is healthcare. This arena is ever-growing and is responsible for treating basic diseases to combating some of the deadliest ones like cancer. The growth of this multi-trillion-dollar sector has enabled doctors to zoom in on specific body organs, such as the eye. An emerging player in eye treatment could be trading at a PREMIUM right now, as it leads the way in eye care advancements. Still in the early stages of its growth story but seeing remarkable gains in recent weeks, OKYO Pharma Limited (NASDAQ: OKYO) is developing first-in-class pharmaceutical therapies to treat inflammatory eye diseases! In the last few weeks shares of OKYO have nearly DOUBLED! At the beginning of August OKYO was trading around $1.22 and hit as high as $2.29 this past Friday. Shares have been trending higher ever since the company provided a corporate update on its lead program in development. To recap: April: - OKYO 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. In May: - OKYO 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.
- OKYO 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. In June: - OKYO 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. In July: - OKYO 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. BULLISH sentiment continues to build for OKYO! [Investing.com]( has a âSTRONG BUYâ rating while [BarChart.com]( has a âWEAK BUYâ rating. Additionally [AmericanBulls.com]( has a âSTAY LONGâ rating. The company also had coverage initiated on it by Goldman Small Cap Research back in May, who gave it a price target of $5.50! You can read the full report [HERE.]( Earlier this year one of the biggest headlines in biotech was the announcement from Astellas Pharma about agreeing to buy U.S. drugmaker Iveric Bio Inc for about [$5.9 billion](. That massive acquisition had closed in July. It is the biggest acquisition for Astellas yet, giving it access to a range of ophthalmology treatmentsâ¦. The sheer magnitude of this deal has emphasized just how important the eye healthcare market is and the potential for OKYO! [www.okyopharma.com]( Company Overview: OKYO Pharma Limited is a life sciences company focusing on the discovery and development of novel molecules to treat inflammatory dry eye diseases (DED) and chronic pain. The companyâs therapeutic approach is focused on targeting inflammatory and pain modulation pathways that drive these conditions. OKYO is focused on the development of OK-101 to treat ocular diseases, including dry eye, uveitis, allergic conjunctivitis, and ocular pain. The company is concentrating on the development of its drug candidate OK-101 to treat ocular diseases, including: - Dry eye (DED) uveitis
- Allergic conjunctivitis
- Ocular pain 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. ChemR23 receptor on leukocytes targeted by OK-101 is also expressed on neurons and glial cells in the dorsal root ganglion and spinal cord. Such patients would benefit from a drug that comprises anti-inflammatory and neuropathic pain-reducing characteristics. The drug candidate 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 âanchorâ contained in the drug molecule to enhance the residence time of OK-101 within the ocular environment. As a Drug Candidate - Inflammation and pain are the most common symptoms of dry eye
- OK-101 is a novel class of chemerin receptor agonist that produces an anti-inflammatory action and reduction in neuropathic pain
- Inclusion of a lipid âanchorâ within the OK-101 drug molecule is designed to decrease washout due to tearing and blinking, and to enhance the ocular residence time of OK-101 Rapid Clinical Development - IND application cleared in Q4 2022
- Able to skip Phase 1 safety trial and go directly to Phase 2 safety and efficacy trial in dry eye disease patients
- Phase 2 trial in dry eye disease patients started May 2023
- Topline data expected in Q4 2023 It wasnât that long ago that the U.S. Food and Drug Administration (FDA) cleared OKYOâs Investigational New Drug (IND) to initiate a Phase 2, first-in-human, clinical study of OK-101 for the treatment of Dry Eye Disease (DED)! This trial is now underway and takes it closer and closer to a possible FDA approval! OK-101, the companyâs game-changing drug candidate could put OKYO on the map. âOne of the most exciting aspects of this innovative clinical program is that we can get a rapid and informative answer on both safety and efficacy of OK-101 by the end of the year,â said Gabriele Cerrone, Executive Chairman and Founder of OKYO Pharma. âFurthermore, positive results would allow us to expedite the program towards FDA approval by leveraging results from this phase 2 dry eye trial in lieu of one of the two required phase 3 trials needed to support U.S. marketing authorization. OKYO remains well-positioned as novel ophthalmic compounds in large markets represent promising acquisition targets as evidenced by the recent $5.9 billion Iveric deal.â If OKYOâs OK-101 phase 2 trial is successful, it may serve as one of two required phase 3 studies necessary to support FDA approval! In Summaryâ¦. The growing eye industry is something investors canât ignore much longer. The broader eyecare market was worth $6.6 billion in 2021 according to a report]( Reports and Data. From this, the firm expects the market to grow at a 3.8% CAGR by 2030 and be worth an estimated $42.5 billion by the end of the forecast period! The research firm believes that one of the primary drivers of growth in this market is the growth in screen time for both younger and older adults, especially since computer screens and other products are regularly used for a wide variety of uses including entertainment and work. OKYOâs immediate 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 activity. This would be a FIRST! Dry eye patients suffer from corneal neuropathic pain, making their condition more resistant to anti-inflammatory drugs. Currently, there is NO FDA-approved topical treatment for ocular pain. Top-line data from OKYOâs Phase 2 trial is anticipated before the year ends⦠keep an eye out for this!! Could there be FDA approval in OKYOâs future for OK-101? Start your research right away! Copyright 2023 © SCDalerts.com is owned and operated by the owner of SCD Media LLC. Disclaimer and Privacy For more Information please contact info@smallcapsdaily.com This website provides information about the stock market and other investments. This website does not provide investment advice and should not be used as a replacement for investment advice from a qualified professional. 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