Global biopharmaceutical firms Santen SA and Sydnexis have entered an exclusive licensing deal for a drug formulation that aims to treat progressive myopia.

SYD-101 is an investigational low-dose atropine sulfate ophthalmic solution that’s designed to achieve efficacy, stability, and reduce discomfort in patients diagnosed with progressive myopia. According to Dr. Martia Brandner of the Department of Ophthalmology at the Medical University of Graz, Austria, uncorrected myopia is the leading cause of distance vision impairment. Children at the early onset of the disease are at a greater risk of developing long-term eye complications.

The SYD-101 formulation is undergoing a large-scale Phase III clinical trial called the STAAR study in the United States and Europe.

“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,” added Dr. Brandner in a press release.

Current solutions involving compounded atropine, while effective, have a limited shelf life. It also only remains stable if markedly acidified, which can cause stinging and burning when used with children. SYD-101 reportedly has a unique formulation that stays pharmacologically stable at room temperature for as long as three years without lowering the pH.

Myopia is a growing public health challenge worldwide that’s expected to affect 5 billion people by the year 2050. In Europe, myopia cases are estimated to rise to around 42% by the end of the decade. Much of the severity and incidence of the disease is attributed to lifestyle choices, mainly as children now spend less time outdoors and more time on near-vision activities, such as studying, reading and using digital devices.

If left untreated, progressive myopia could lead to serious eye diseases such as cataracts, retinal detachment and glaucoma later in life. At present, myopia in children is addressed by using prescription eyeglasses or contact lenses, which do not slow its progression. The European Society of Ophthalmology has, in the meantime, advocated the controlled use of atropine and encouraged increased time outdoors.

“Children’s eye health is an important part of their overall health and influences their development. Without treatment, the long-term complications associated with myopia continue to impair patients’ lives well into adulthood. Through this collaboration, we will also continue to learn from patient experiences so we can apply our combined expertise and tackle the growing burden of this childhood eye condition,” commented Santen EMEA president and head Luis Iglesias.

The agreement between Santen and Sydnexis covers Europe, Middle East, and Africa (EMEA) region.