August 10, 2021: “Santen SA, a specialist in ophthalmology, and Sydnexis Inc., a
biopharmaceutical company focused on the development of therapies for the treatment of progressive myopia, announce the signing of an exclusive licensing agreement for SYD-101, Sydnexis’ investigational proprietary low dose atropine formulation, for Europe, Middle East and Africa (EMEA).
SYD-101 is currently undergoing a large multicenter phase III clinical trial, the STAAR study, in Europe and the US.
If the study is successful and SYD-101 is thereafter approved, it will address the need for a medical product to help control myopia progression.
“Uncorrected myopia is the leading cause of distance vision impairment and it is children with early onset who are at greater risk of long-term eye complications,” says Dr Martina Brandner, Department of Ophthalmology, Medical University of Graz, Austria.
“At present, only the symptoms of myopia are corrected and so researching SYD-101 in the largest clinical study in this field is a critical step in finding a treatment to target the underlying disease.”
SYD-101 is an investigational low-dose atropine sulfate ophthalmic solution, 0.01% and 0.03%, designed to achieve efficacy, stability and reduce discomfort for improved treatment continuity.
While published reports have shown low concentrations of compounded atropine to be effective, these solutions are limited by a short shelf life and remain only stable if markedly acidified, which can also cause excessive burning and stinging in children.
Based on its unique and proprietary formulation, SYD-101 is an investigational low-dose atropine formulation designed to be pharmacologically stable without needing to
lower the pH in order to achieve a shelf life of up to three years at room temperature.”
