Santen Enters Exclusive Licensing Agreement for SYD-101, a Novel Low-Dose Atropine Therapy for Childhood Myopia

On August 10, 2021, Santen Pharmaceutical (Santen) and Sydnexis announced an exclusive licensing agreement for the development and commercialization of Sydnexis’s investigational low-dose atropine formulation, SYD-101, in Europe, the Middle East, and Africa (EMEA). SYD-101 addresses the stability issues of low-concentration atropine in a neutral environment and is intended for the treatment of pediatric myopia. The drug is currently undergoing a large, multicenter Phase 3 clinical trial, which will assess the efficacy and safety of two doses of SYD-101 (0.01% and 0.03%) for the treatment of myopia in over 850 children aged 3 to 14 years.

As one of the most common ocular disorders, myopia represents a growing public health challenge and is projected to affect 5 billion people worldwide by 2050. The rising incidence and severity of the condition are primarily attributable to lifestyle changes. With children spending increased time on reading, studying, and digital devices, alongside reduced outdoor activity—a trend further exacerbated by COVID-19 home confinement measures—the incidence of myopia has surged dramatically. Without treatment, high or rapidly progressive myopia can lead to severe ocular complications, including glaucoma, cataracts, and retinal detachment, potentially resulting in irreversible vision loss. Current management relies on corrective spectacles or contact lenses, which do not effectively slow disease progression.

As a muscarinic cholinergic receptor antagonist, atropine eye drops were originally indicated primarily for cycloplegic refraction. Scientists subsequently discovered that low-concentration atropine is effective in the treatment of myopia. However, these formulations are pharmaceutically highly unstable; the closer the pH approaches the physiological level (7.4) and the lower the atropine concentration, the higher the degradation rate, with significant degradation occurring within just three months at room temperature. Stability is maintained only under markedly acidic conditions, which in turn triggers treatment-related adverse reactions such as excessive ocular burning and stinging in patients.

▲ Atropine Molecular Structure (Image source: Harbin, Public domain, via Wikimedia Commons)

SYD-101 is an investigational low-dose atropine sulfate ophthalmic solution designed to achieve therapeutic efficacy for childhood myopia while enhancing stability and minimizing discomfort, thereby improving treatment adherence. SYD-101 does not require pH reduction and maintains a shelf life of up to three years at room temperature.

“Children’s eye health is an integral part of their overall health. As part of this agreement, we will work together to bring SYD-101 to the EMEA market,” said Mr. Luis Iglesias, President and Head of EMEA at Santen Pharmaceutical. “If left untreated, long-term complications associated with myopia will continue to adversely affect patients’ lives. Through this collaboration, we will also continue to learn from patient experiences, enabling us to apply our comprehensive expertise to address the growing burden of this pediatric eye disease.”

References:

[1] Santen and Sydnexis execute an exclusive licensing agreement for SYD-101, a novel investigational treatment for progressive childhood myopia. Retrieved August 10, 2021, from https://www.santen.eu/our-vision/emea-news/santen-and-sydnexis-execute-exclusive-licensing-agreement-syd-101-novel; https://sydnexis.com/prJuly2021_Santen.html

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