Sydnexis Announces UK Approval of Ryjunea® by Partner Santen to Slow Progression of Childhood Myopia

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.