Sydnexis Announces Positive CHMP Opinion in Europe for SYD-101 for Slowing the Progression of Pediatric Myopia

News, SydnexisBy Garrett Hamontree April 1, 2025

Sydnexis, Inc. announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has granted a positive opinion for its proprietary low-dose atropine formulation, SYD-101, for slowing the progression of pediatric myopia. Santen SA licensed the rights from Sydnexis to commercialize SYD-101 under the brand name Ryjunea® in the regions of Europe, Middle East, and Africa (EMEA). Santen SA is the Switzerland-based affiliate of Santen Pharmaceutical Co., Ltd., a Japan-based company specialized in eye health, offering innovative products and services in over 60 countries worldwide.

Sydnexis Announces FDA Acceptance of NDA for SYD-101 for the Treatment of Progression of Pediatric Myopia

News, SydnexisBy Garrett Hamontree March 13, 2025

Sydnexis announced that the FDA has accepted its new drug application (NDA) for SYD-101, which if approved would be the first and only pharmaceutical option for the treatment of progression of pediatric myopia in the United States. The FDA assigned a Prescription Drug User Fee Act (PDUFA) target action date of October 23, 2025.

Santen Announces Sydnexis European Pivotal Data

News, SydnexisBy Garrett Hamontree February 6, 2025

Santen announced Sydnexis SYD-101 Phase III clinical data and is expecting European approval in early 2025 for the treatment of pediatric progressive myopia. Santen licensed SYD-101 for Europe, Middle East, and Africa from Sydnexis. Sydnexis is also seeking approval for the United States. Pediatric progressive myopia impacts ~28 million patients in the United States alone. Left untreated leads to immediate loss of QOL for patients and increases vision risks later in life: cataract (5x), glaucoma (14x), retinal detachment (44x), & myopic maculopathy (348x).

Perry J. Sternberg Joins Sydnexis as Chief Executive Officer

News, SydnexisBy Garrett Hamontree July 17, 2024

Sydnexis, Inc., (www.sydnexis.com) a pre-commercial stage biopharmaceutical company focused on the treatment of progression of pediatric myopia, is excited to announce the appointment of Perry J. Sternberg as Chief Executive Officer and as a member of the Board of Directors. An accomplished pharma/biotech executive with over 30 years in the industry and 15 years in eye care, Perry will provide invaluable leadership experience to help guide Sydnexis’ strategic direction and next phase of growth.

Global Pharma Company, Santen, and Visionary Portfolio Company, Sydnexis, Unite To Vanquish Childhood Myopia

License Deal, News, SydnexisBy Garrett Hamontree August 10, 2021

Global biopharmaceutical firm Santen SA and Sydnexis have entered an exclusive licensing deal for a drug formulation that aims to treat progressive myopia. The agreement covers Europe, Middle East, and Africa (EMEA) region.

Sydnexis Secures $45 Million Series B Financing Led by Visionary Ventures and Blue Stem Capital

News, SydnexisBy Garrett Hamontree August 10, 2021

Visionary Ventures led a $45MM round into its 12th portfolio company, Sydnexis. Sydnexis is a clinical stage biopharmaceutical company with a proprietary formulation of low dose atropine for the treatment of progressive myopia, today announced the completion of a $45 million Series B financing led by Visionary Ventures, Blue Stem Capital, and SC Master Fund, with participation from existing investors RA Capital Management, Longitude Capital, and Medicxi. The financing will be used to fund Sydnexis’ lead candidate, SYD-101, through completion of the fully enrolled pivotal Phase 3 STAAR study for the treatment of progressive myopia in children.

Category Archives: Sydnexis