ð¨Trade Alert ð¨ OKYOÍ â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â This little-known company may end up becoming the BIGGEST name in treating dry eye disease one day⦠Greetings Investors, Itâs time to direct attention to a little-discussed space that has been getting a much-deserved buzz this month: the eye disease arena. This month Japan's Astellas Pharma agreed to buy U.S. drugmaker Iveric Bio Inc for about billion]( in its biggest acquisition, giving it access to a range of ophthalmology treatmentsâ¦. The Iveric deal gives it drug candidates to treat some 160 million people worldwide suffering from eye ailments, particularly in its home market of Japan which has one of the world's fastest aging populations. A deal of this magnitude clearly shows just how lucrative the eye market is and could catapult Okyo Pharma Limited into the spotlight! Trading on the NASDAQ under the ticker symbol OKYO, the company is developing first-in-class pharmaceutical therapies to treat inflammatory eye diseases. 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 DED! OKYO is focused on the development of OK-101 to treat ocular diseases, including dry eye, uveitis, allergic conjunctivitis, and ocular pain. In recent days shares of OKYO have more than doubled when they hit a high of roughly $3.25 on May 8th. In mid-April shares were only around $1.15 a share! Trading volume has also been growing immensely as Wall Street is keeping its eyes peeled for more developments on the companyâs Phase 2 trial of OK-101. Earlier this month 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 dry eye disease (DED). This game-changing drug candidate could put OKYO on the map and relatively soon! 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. The top-line data from the trial is anticipated before the year ends! OK-101 would be a game changer in treating dry eye disease and would address a significant unmet need in a multi-billion-dollar market. BULLish ratings are piling up for OKYO as the companyâs promising drug candidate could become a household name in treating eye disease. [Investing.com]( currently has a âSTRONG BUYâ rating while [AmericanBulls.com]( has a âStay Longâ rating. OKYO also has a [$4.64 price target]( on it, indicating more than 100% in potential upside at present levels. Okyo Pharma Limited (NASDAQ: OKYO) (LSE: OKYO) is a quietly trading biopharma company that is leading the way in eye care advancements and is still in the early stages of its growth story. Put the company high on your radar! [www.okyopharma.com]( OKYO Pharma Limited NASDAQ: OKYO 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 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. About the Phase 2 Trial DesignThis phase 2, multi-center, randomized, doubleâblinded, placebo-controlled study is planned to enroll approximately 240 subjects with DED who will be randomly divided into 3 cohorts of 80 patients. Participants will be selected based on specific inclusion and exclusion criteria. The three cohorts will be comprised of one cohort treated with placebo, a second cohort treated with a low dose of OK-101, and the third cohort receiving a higher dose of OK-101. The drug and placebo will be administered in both eyes twice daily for 12 weeks. The duration of a patientâs treatment will be approximately 14 weeks, including a 2-week run-in period and 12 weeks of treatment. The protocol for the study includes two prespecified primary endpoints and a number of secondary endpoints. Further details regarding the specifics of the trial are posted on the ClinicalTrials.gov public website (ClinicalTrials.gov Identifier: NCT05759208). The Market: The healthcare arena is just what the doctor ordered for 2023 as inflation continues and a recession looms. Healthcare is one of the most stable industries, and people will continue to spend money on medicine regardless of how the economy is doing. Additionally, the [World Health Organization (WHO)]( has estimated that the number of people who are aged 60 and older will almost double by 20250! The market will reach a staggering 426 million people. What does this mean? It means more prescription drugs will keep older people healthy and active as their bodies wear down. As baby boomers age, eye issues continue to boom. As more people spend their time on screens, eye issues continue to accelerate. The growing eye industry is something investors canât ignore much longer. Of your five senses, eyesight ranks pretty high up there. And when eyes are affected by various conditions, people will do what they can to alleviate their symptoms and improve their eye condition. Dry eyes are one of the most common eye conditions. Itâs no surprise that the market has become extensive for dry eye drugs including brand names like Novartisâ Xiidra and Allerganâs Restasis. Dry eye disease is a common condition that occurs when an individualâs tears are unable to adequately lubricate the eyes. The 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. Several contributing factors can lead to this condition, including age, sex, certain medical conditions, reduced tear production and tear film dysfunction. Tear film instability typically leads to inflammation and damage to the ocular surface. Company Highlights: - 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. - Worldwide, [700 million patients]( from dry eye disease. In the United States, 30 million patients suffer from dry eye disease.
- Currently, there is NO FDA approved topical treatment for ocular pain. - OKYOâs drug candidate OK-101 has stellar potential to capture a big piece of the eye disease market. - In an animal model, OKYOâs lead drug candidate OK-101 was effective in suppressing ocular inflammation by downregulating key inflammatory CD4+ T cells. Additional studies are ongoing to determine the efficacy of OK-101 in diminishing ocular redness, the most common symptom of allergic conjunctivitis. - The company has received FDA clearance for its Investigational New Drug (IND) application from the U.S. Food and Drug Administration (FDA) to initiate a Phase 2, first-in-human, clinical study of OK-101 for the treatment of DED. The market potential would be immense if OK-101 is FDA approved. - OKYO has patent protection until 2039! - The company has an experienced team with considerable drug development expertise. - OKYOâs team is optimistic about the companyâs growth potential as it was revealed after announcing an upcoming private stock placement that senior management has deferred wages, taking stock as payment instead! In summary⦠What makes OKYO stand out in the massive eye treatment space is a new chemical entity that targets BOTH inflammation and ocular pain in dry eye disease! Something that has yet to be done!Such a solution opens a wide door for OKYO to tap into an underserved niche market and creates a substantial potential for shareholder growth. Last month the company 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 dry eye disease. âOKYOâs primary focus continues to be on advancing the clinical development of OK-101 as a potential treatment option for dry eye disease, a chronic ocular condition that affects roughly 700 million people worldwide,â said Gary S. Jacob, Ph.D., CEO of OKYO Pharma. âWith the activation of our first clinical site we are now very close to the opening of the OK-101 phase 2 trial and are looking forward to initiating enrollment and completing the trial before the end of the year." Could there be FDA approval in OKYOâs future for OK-101? Only time will tell but keep an eye out for any developments from the company! Start your research right away! 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