Brinzolamide/Brimonidine tartrate

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

DALLAS, Oct. 26, 2023 /PRNewswire/ -- Nanoscope Therapeutics Inc., a clinical-stage biotechnology company developing gene therapies for inherited retinal diseases, today announced the appointment of Najam Sharif, PhD, DSc, a veteran in drug/device discovery and development, as Vice President of Global Research and Development. "We are delighted to welcome Naj to the Nanoscope team," said Sulagna Bhattacharya, Co-Founder and Chief Executive Officer of Nanoscope. "His extensive experience in ophthalmology and pharmaceutical drug discovery and development is a natural fit for our organization, and we look forward to drawing on his clinical and regulatory expertise in particular at this pivotal time for MCO-010." "I am honored to join Nanoscope, a company that I see as transformative in the field of ophthalmology. As their lead asset, MCO-010, advances toward FDA approval, I look forward to the opportunity to positively impact the lives of people living with inherited retinal diseases, and to bring treatment options to a population for which there are no established cures," said Dr. Sharif. Dr. Naj Sharif brings over three decades of experience in pharmaceutical drug/device discovery and development to Nanoscope, including specialized expertise in ophthalmology and neuroscience. Throughout his career, he contributed to the discovery and development of several FDA-approved commercial drugs, including anti-glaucoma agent Travatan® and anti-allergic/inflammatory drugs such as Patanol® /Pataday® and Emedine®. In addition, Dr. Sharif was instrumental in guiding three drugs through to FDA approvals: Simbrinza® for glaucoma, IZBA® for the treatment of ocular hypertension and glaucoma, and PAZEO™ for the treatment ocular allergies. Most recently, Dr. Sharif served as Vice President, Global Biomedical Sciences & Head of Glaucoma and Neuroprotection at Santen, where he managed the company's Clinical Sciences, Data Sciences, and Biometrics departments, and where he also established and directed Global Alliances & External Research activities. Prior to this, he held positions related to R&D and regulatory affairs at Alcon Research-Novartis, Synaptic Pharmaceutical Corp, and Syntex Pharma / Roche Pharmaceutical Corp. He is widely published with an extensive number of peer-reviewed publications, edited books and holds multiple patents for mitigation of neurological and ophthalmic diseases. He has been an invited organizer, chairman and speaker at multiple national and international conferences. In addition to his professional experience, Dr. Sharif has served on numerous boards and committees. Dr. Sharif is an elected Fellow of multiple learned societies such as Association for Research in Vision and Ophthalmology, Association for Ocular Pharmacology and Therapeutics and British Pharmacological Society. Currently he serves on the Scientific Advisory Board of the Glaucoma Foundation and as an adjunct professor for the Duke-NUS Medical School in Singapore, and Institute of Ophthalmology at University College London. He is the recipient of several honors, including the Ernst H. Barany prize for "Outstanding Contributions to Ocular Pharmacology", the first and inaugural "Dr. Roger Vogel Award" for Pharmaceutical Research, and the Sir James Black Award for "Contributions to Drug Discovery". Dr. Sharif received a PhD in neuroscience, DSc (by thesis) in ophthalmology, and dual bachelor's degree in physiology and biochemistry from the University of Southampton (UK). About Nanoscope Therapeutics Inc. Nanoscope Therapeutics is developing gene-agnostic, sight-restoring optogenetic therapies for the millions of patients blinded by inherited retinal diseases, for which no cure exists. The company's lead asset, MCO-010, recently reported topline results from the RESTORE Phase 2b multicenter, randomized, double-masked, sham-controlled clinical trial in the U.S. for retinitis pigmentosa (NCT04945772). The company has also recently completed their end-of-study visit for the Phase 2 STARLIGHT trial of MCO-010 therapy in Stargardt patients (NCT05417126). MCO-010 has received FDA fast track designations and FDA orphan drug designations for both retinitis pigmentosa and Stargardt. Preclinical assets include non-viral laser-delivered MCO-020 gene therapy for geographic atrophy. Investor Contact: Argot Partners 212-600-1902 [email protected] SOURCE Nanoscope Therapeutics