Latanoprost/Netarsudil dimesylate

AR-15512, a topical transient receptor potential melastatin 8 (TRPM8) agonist, is a first-in-class product candidate for the treatment of the signs and symptoms of dry eye disease In both pivotal efficacy and safety studies (COMET-2 and COMET-3), the primary endpoint was achieved (p <0.0001) Dry eye affects an estimated 38 million people in the U.S. and less than 10% of diagnosed patients are treated with a prescription product1 GENEVA--(BUSINESS WIRE)-- Alcon (SIX/NYSE: ALC), the global leader in eye care dedicated to helping people see brilliantly, today announced positive topline results from the two pivotal Phase 3 clinical trials (COMET-2 and COMET-3) evaluating the efficacy and safety of AR-15512, a candidate treatment for the signs and symptoms of dry eye disease (DED). In both COMET-2 and COMET-3, which enrolled more than 930 dry eye subjects in total (randomized 1:1 to AR-15512 or vehicle control), the primary endpoint of the proportion of subjects with at least a 10-mm increase in unanesthetized Schirmer’s score (a measure of tear production) achieved statistical significance at Day 14 [p<0.0001]. These data are consistent with the proposed mechanism of action of AR-15512. “We are excited by AR-15512 as it has the potential to address the limitations of current dry eye prescription options and provide Eye Care Professionals (ECPs) and dry eye sufferers with a new and effective approach to the management of dry eye, a chronic and undertreated disease,” said David Endicott, CEO of Alcon. “AR-15512 is the first product candidate in our emerging ophthalmic pharmaceutical portfolio, representing our legacy of commitment to innovation in eye care.” AR-15512 represents an opportunity to bring relief to dry eye sufferers. While DED is one of the most common ocular disorders, affecting an estimated 38 million people in the U.S., only about 18 million are diagnosed and less than 10% of those diagnosed are treated with a prescription product. This represents the significant need for an effective chronic treatment that can provide rapid natural tear production.1 In these studies, additional data derived from secondary endpoints demonstrated the rapid onset and sustained tear production associated with AR-15512 compared to vehicle, as early as Day 1 and persistent to Day 90. Overall, AR-15512 was well tolerated and no serious ocular adverse events were reported. “A key gap in dry eye medications is rapid speed of onset,” said Edward Holland, MD, Professor of Ophthalmology at the University of Cincinnati, a key advisor on COMET-2 and -3 and Senior Scientific Advisor at Alcon. “AR-15512 demonstrated this important achievement in both pivotal efficacy and safety studies and it represents a first-in-class candidate for chronic dry eye.” AR-15512 is an investigational drug product that has not been submitted to the U.S. Food and Drug Administration (FDA) for approval and is not currently commercially available. Alcon anticipates filing the NDA for AR-15512 with FDA in mid-2024. Alcon's ophthalmic pharmaceutical portfolio currently includes Rocklatan®, Rhopressa®, Simbrinza®, Eysuvis®, and Inveltys®. About Dry Eye Dry eye disease is one of the most common ocular surface disorders, affecting an estimated 38 million adults in the United States and an estimated 719 million more adults globally.1 While once considered a disease of aging populations, modern advancements, such as prolonged digital screen time, have contributed to a significant rise in DED across age and gender.2 Many existing prescription options for dry eye disease are generally regarded by many eye care professionals and patients as inadequate due to low treatment efficacy, slow onset of action and/or poor tolerability.3 About Alcon Alcon helps people see brilliantly. As the global leader in eye care with a heritage spanning over 75 years, we offer the broadest portfolio of products to enhance sight and improve people’s lives. Our Surgical and Vision Care products touch the lives of more than 260 million people in over 140 countries each year living with conditions like cataracts, glaucoma, retinal diseases and refractive errors. Our more than 25,000 associates are enhancing the quality of life through innovative products, partnerships with Eye Care Professionals and programs that advance access to quality eye care. Learn more at . Cautionary Note Regarding Forward-looking Statements This press release contains “forward-looking statements” within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as: “anticipate,” “intend,” “commitment,” “look forward,” “maintain,” “plan,” “goal,” “seek,” “target,” “assume,” “believe,” “project,” “estimate,” “expect,” “strategy,” “future,” “likely,” “may,” “should,” “will” and similar references to future periods. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties and risks that are difficult to predict. Some of these factors are discussed in our filings with the United States Securities and Exchange Commission, including our Form 20-F. Should one or more of these uncertainties or risks materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those anticipated. Therefore, you should not rely on any of these forward-looking statements. Forward-looking statements in this press release speak only as of the date they are made, and we assume no obligation to update forward-looking statements as a result of new information, future events or otherwise. References Market Scope 2023 Dry Eye Product Market Review; does not include OTC artificial tears and other Rx anti-inflammatory and tear stimulants. The Relationship Between Dry Eye Disease and Digital Screen Use - PMC (nih.gov) Improved Dry Eye Drugs for 2022 and Beyond; Connect with us on Facebook LinkedIn

Phase 1 clinical data to be released in conjunction with Investor Day San Diego, California--(News - October 19, 2023) - Skye Bioscience, Inc. (OTCQB: SKYED) ("Skye" or the "Company"), a pharmaceutical company developing drugs targeting the endocannabinoid system, initially through modulation of the CB1 receptor, to address diseases including glaucoma and metabolic conditions, announces that it will host a virtual Investor Day, called "CB1 Axis: Unlocking the Pharmaceutical Potential of the Endocannabinoid System", on Wednesday, October 25, 2023 at 8:00am ET. To register, click here. In conjunction with this event, Skye will also release its Phase 1 clinical data. The event will feature Brian Levy, O.D. (former CMO, Aerie and Bausch & Lomb), Glenwood Gum, Ph.D. (Pharmaron), and Sameh Mosaed, M.D., Ph.D. (UC Irvine), who will provide an overview of the current glaucoma commercial landscape, drug development pipeline, and perspective on the historical challenges to achieving CB1-targeting therapeutics for the treatment of glaucoma. Skye leadership will provide broad insight into SBI-100 Ophthalmic Emulsion, its CB1 agonist being developed to potentially treat glaucoma, including a nonclinical data overview, clinical data from the company's recently completed Phase 1 study, a Phase 2 clinical update, and an outline of the glaucoma market opportunity and Skye's positioning strategy. A live question and answer session will follow the formal presentations. About Brian Levy, O.D. Dr. Brian Levy, CEO of InflammX Therapeutics, leads the development of Xiflam for dry AMD and diabetic eye/kidney diseases, now in a Phase 2 trial with NIH's DRCR Retinal Network. Formerly CMO at Aerie Pharmaceuticals, he pioneered rho kinase inhibition treatments, including the approvals of Rhopressa® and Rocklatan®. As VP of R&D at Bausch & Lomb for 15 years, he oversaw approvals of Retisert, Zylet, and Besivance. A seasoned ophthalmologist with over 50 publications, Levy holds degrees from UC Berkeley and University of Waterloo. About Glenwood Gum, Ph.D. Dr. Gum has 40+ years' experience in ophthalmology research and development in an academic and industry setting. As the Sr. Director of Ophthalmology at Pharmaron, he's advanced ocular studies, especially using the glaucomatous beagle model. His collaboration with renowned pharmaceutical companies has led to breakthroughs in beta blockers, cannabinoids, and prostaglandins. About Sameh Mosaed, M.D., Ph.D. Dr. Sameh Mosaed, MD, is a Professor of Ophthalmology and Chief of Glaucoma at UC Irvine's Gavin Herbert Eye Institute. She directs the glaucoma fellowship training program and is renowned for her minimally invasive glaucoma surgery expertise. Dr. Mosaed is credited with over 50 published papers and numerous textbook chapters. About SBI-100 Ophthalmic Emulsion Skye's SBI-100 OE possesses a novel molecular structure and nanoemulsion formulation designed to enable effective topical delivery and better penetration of a CB1 agonist into ocular tissue. In preclinical studies involving three different species, the drug resulted in enhanced therapeutic efficacy and duration of response in lowering IOP, comparing favorably to the standard of care for treating glaucoma. About Skye Bioscience Skye is focused on unlocking the pharmaceutical potential of the endocannabinoid system to treat diseases with inflammatory, fibrotic, and metabolic processes. Backed by leading life science venture investors, Skye's strategy leverages biologic targets with substantial human proof of mechanism for the development of first-in-class therapeutics with significant clinical and commercial differentiation. Nimacimab, a negative allosteric modulating antibody, inhibits peripheral CB1 with unprecedented safety and tolerability. A Phase 2 cardio-metabolic related indication study is expected to start in Q1 2024. Skye is also evaluating potential development paths for nimacimab related to obesity and weight loss. SBI-100 Ophthalmic Emulsion is a CB1 agonist that is a potential treatment for glaucoma and is expected to start a Phase 2 clinical trial in Q4 2023. For more information, please visit: . CONTACT Investor Relations Email: ir@skyebioscience.com Phone: (858) 410-0266 FORWARD-LOOKING STATEMENTS This letter contains forward-looking statements, including statements regarding our product development, business strategy, the timing of clinical trials, and commercialization of cannabinoid-derived therapeutics. Such statements and other statements in this press release that are not descriptions of historical facts are forward-looking statements that are based on management's current expectations and assumptions and are subject to risks and uncertainties. If such risks or uncertainties materialize or such assumptions prove incorrect, our business, operating results, financial condition, and stock price could be materially negatively affected. In some cases, forward-looking statements can be identified by terminology including "anticipated," "plans," "goal," "focus," "aims," "intends," "believes," "can," "could," "challenge," "predictable," "will," "would," "may" or the negative of these terms or other comparable terminology. We operate in a rapidly changing environment, and new risks emerge from time to time. As a result, it is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements the Company may make. Risks and uncertainties that may cause actual results to differ materially include, among others, our capital resources, uncertainty regarding the results of future testing and development efforts and other risks that are described in the Risk Factors section of Skye's most recent annual or quarterly report filed with the Securities and Exchange Commission. Except as expressly required by law, Skye disclaims any intent or obligation to update these forward-looking statements. To view the source version of this press release, please visit