Santen Pharmaceutical Co., Ltd.

DEL MAR, Calif.--(BUSINESS WIRE)--Sydnexis, Inc., (www.sydnexis.com), a biopharmaceutical company focused on pediatric progressive myopia (PPM), today noted its partner Santen’s announcement that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved Ryjunea® (low-dose atropine 0.1 mg/ml), the first MHRA approved treatment in the UK to slow the progression of myopia in children aged 3-14 years with a progression rate of 0.5 D or more per year and a severity of -0.5 D to -6.0 D. This approval comes after authorization by the European Commission and the initial launch in Germany earlier this year. Sydnexis’ low-dose atropine eye drop SYD-101 is licensed to Santen in Europe, the Middle East, and Africa, which Santen commercializes under the brand name Ryjunea®. Santen is a global pharmaceutical company with over 135 years of experience dedicated to advancing eye health and improving lives through better vision. “We are thrilled that the MHRA has granted approval of Ryjunea® to Santen, marking another important milestone in bringing this innovative therapy to even more patients in need,” said Perry Sternberg, Chief Executive Officer of Sydnexis. “Backed by the global STAR study, this announcement underscores the potential of an approved low-dose atropine solution to address a significant unmet medical need for children with progressive myopia worldwide.” About Sydnexis, Inc. Sydnexis, Inc. is a biopharmaceutical company dedicated to advancing care for pediatric progressive myopia. The company’s lead compound, SYD-101, is currently approved in the European Union, where it is licensed to Santen S.A. and marketed as Ryjunea®. Sydnexis is supported by leading life-science investors, including Visionary Ventures, RA Capital, Longitude Capital, and Bluestem Capital. For more information on Sydnexis, please visit www.sydnexis.com.

The FDA rejected approval of Sydnexis' SYD-101 to slow the progression of paediatric myopia in children, with the agency citing a lack of supporting data. "We are surprised and disappointed with this decision," remarked CEO Perry Sternberg, although he noted that the company "is committed to working" with the FDA to address the items outlined in the complete response letter (CRL).SYD-101 is a low-dose atropine formulation developed with enhanced ocular delivery characteristics and room-temperature stability. The 0.1 mg/mL ophthalmic solution was approved earlier this year in Europe, where it is marketed by Santen Pharmaceutical as Ryjunea, as once-daily therapy for children aged 3 to 14 years at treatment initiation, having myopia progression of ≥0.5 D per year and a severity of -0.5 D to -6.0 D.Sydnexis' filing to the FDA was supported by results from the Phase III STAR study, which met its primary efficacy endpoint of the proportion of patients with confirmed progression of -0.75D. A key secondary trial goal, annual progression rate, also met statistical significance at 12, 24 and 36 months. While the FDA acknowledged in the CRL that the STAR study's primary endpoint was met, the agency said the data do not support the effectiveness of low-dose atropine in children with myopia. Sydnexis noted that the regulator raised no deficiencies related to safety or product quality.

BOSTON--(BUSINESS WIRE)--Diorasis Therapeutics, a Boston-based biotechnology company developing durable gene therapies for glaucoma and other ophthalmic diseases, today announced the appointment of Dimitri Azar, MD, MBA, AM (hon.), DHL (hon.), to its Board of Directors. First-in-class gene therapy for glaucoma Dr. Azar brings extensive leadership experience and clinical expertise in ophthalmology, biotechnology, and translational medicine. He currently serves as Distinguished Professor of Ophthalmology at the University of Illinois College of Medicine and as President and CEO of Lacristat.AI. Dr. Azar has served on the Board of Directors of Novartis, the Scientific Advisory Board at Verily, Alphabet’s life sciences research arm, and the Board of Verb Surgical, a joint venture between Verily and Johnson & Johnson. Previously, Dr. Azar was Senior Director at Verily and Founding CEO of Twenty Twenty Therapeutics, a joint venture between Santen and Verily, where he led the development of multiple novel diagnostic and therapeutic technologies in glaucoma, dry eye, presbyopia, and ophthalmic drug delivery. An accomplished academic leader, Dr. Azar is Field Chair of Ophthalmic Research and Executive Dean Emeritus at the University of Illinois College of Medicine, a former faculty member at the Johns Hopkins Wilmer Eye Institute, and a former tenured professor at Harvard Medical School. He earned his MD from the AUB and completed his clinical and research training at the Massachusetts Eye and Ear Infirmary and the Schepens Eye Research Institute, respectively. “We are honored to welcome Dr. Azar to our Board of Directors,” said Remis Bistras, Chief Executive Officer of Diorasis Therapeutics. “His deep expertise, global leadership in ophthalmology, and proven track record in innovation will be instrumental as Diorasis advances its first-in-class gene therapy for glaucoma into clinical development.” Following a successful Pre-IND meeting with the U.S. Food and Drug Administration (FDA) and initiation of GMP manufacturing, Diorasis’s lead program in glaucoma is on track to enter clinical development following completion of toxicology studies and regulatory submissions. “Glaucoma remains one of the leading causes of irreversible blindness worldwide,” said Dr. Dimitri Azar. “What excites me about Diorasis is its vision to move beyond chronic, burdensome treatments and offer patients a long-term solution that could dramatically improve quality of life and prevent blindness. For investors, this represents a unique opportunity to be part of a company redefining how we treat one of the most common and devastating ophthalmic diseases.” About Diorasis Therapeutics Diorasis Therapeutics is a Boston-based, pre-clinical stage biotechnology company developing first-in-class, disease-modifying, gene-agnostic therapies for major ophthalmic diseases. The company has built a pipeline of intraocular pressure (IOP)-lowering and neuroprotective gene therapy compounds targeting the most common and devastating diseases of the optic nerve (glaucoma) and retina. Diorasis’s innovative platform is based on a novel mechanism of action and a sustained delivery approach designed to achieve durable, potentially life-long efficacy from a single in-office dose. By addressing the underlying mechanisms of disease rather than symptoms, Diorasis aims to deliver long-term therapeutic benefit to patients worldwide. Despite the availability of eyedrops, laser treatments, and surgery, glaucoma remains the leading cause of irreversible blindness globally — underscoring the urgent need for transformative, disease-modifying treatments. For more information, please visit www.diorasistherapeutics.com