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Santen and Sydnexis execute an exclusive licensing agreement for SYD-101, a novel investigational treatment for progressive childhood myopia

Tue 10 August 2021

Santen SA 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 multicentre phase III clinical trial, the STAAR study, in Europe and the US. 

“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.1,2 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.3,4 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.5

“We are excited to partner with Santen, a recognised global leader in ophthalmology to help fulfill our goal of making SYD-101 available in EMEA. We recognise the expertise that Santen brings to the table in understanding and navigating the registration process in the EMEA region and look forward to collaborating with Santen in addressing the myopia needs in these broader geographic regions,” states Kenneth Widder, CEO of Sydnexis. “Myopia is a global epidemic that has only been exacerbated with the increased computer screen-time during the COVID lock-down.”

As one of the most common ocular disorders, myopia is a growing public health challenge projected to affect 5 billion people globally by 2050.6-8 In Europe alone, the prevalence of myopia is estimated to increase to almost 42% by the end of this decade.8 The growing incidence and severity of the condition are largely attributed to lifestyle changes as children are spending more time on near-vision activities (reading, studying and using digital devices) and less time outdoors, further exacerbated by COVID-19 preventative measures.6,9 In the absence of treatment, high or fast-progressing myopia can lead to serious eye health concerns such as glaucoma, cataract and retinal detachment later in life that can cause irreversible vision loss.8 Currently, childhood myopia in Europe is corrected with prescription glasses or contact lenses, which do not slow its progression. In response to the rising number of cases, the European Society of Ophthalmology has issued guidance advocating for the inclusion of atropine treatment as well as promoting increased outdoor time.9

“Children’s eye health is an important part of their overall health and influences their development and so Santen is proud to be partnering with Sydnexis in the area of childhood myopia. As part of this agreement, we will work together to bring SYD-101 to the market in EMEA,” says Luis Iglesias, President and Head of Santen EMEA. “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.”

“On July 23, the United Nations General Assembly adopted the first ever resolution on eye health with the linkage between eye health and Sustainable Development Goals. This announcement represents a major leap to reduce the loss of social and economic opportunities for people around the world due to eye health conditions,” said Shigeo Taniuchi, President & CEO of Santen. “We see myopia as a growing social issue and we firmly commit to tackle this disorder for serving patients’ unmet needs as a specialised ophthalmology company. It will also become a growth driver in our mid-to-long-term business. By adding SYD-101 to our existing pipelines, this partnership can enable us to build our business foundations globally in an efficient manner to serve myopia patients in need.”

References

  1. Chua WH, Balakrishnan V et al., Atropine for the treatment of childhood myopia. Ophthalmol. 2006; 113: 2285-91.
  2. Tong l, Huang XL et al., Atropine for the treatment of childhood myopia: Effect on myopia progression after cessation of atropine. Ophthalmol. 2009; 116(3):572-579
  3. Polling JR, Kok RG et al., Effectiveness study of atropine for progressive myopia in Europeans. Eye. 2016; 30(7):998-1004
  4. Diaz-Llopis M, Pinazo-Duran MD. Super diluted atropine at 0.01% reduces progression in children and adolescents. A 5 year study of safety and effectiveness. Arch Soc Esp Oftalmol. 2018; 93(4):182-185 
  5. Sydnexis internal stability data. Data on file.
  6. Burton MJ, Ramke J et al., The Lancet Global Health Commission on Global Eye Health: Vision beyond 2020. Lancet. 2021; 9(4): 489-551
  7. Eye Disease Prevalence Research Group. The prevalence of refractive errors among adults in the United States, Western Europe and Australia. Arch Ophthalmol. 2004; 122(4): 495-505
  8. Holden BA, Fricke TR et al., Global prevalence of myopia and high myopia and temporal trends from 2000 through 2050. Ophthalmol. 2016;123(5):1036–42
  9. Nemeth J, Tapaszto B et al., Update and guidance on management of myopia. European Society of Ophthalmology in cooperation with International Myopia Institute. Eur J Ophthalmol. 2021

Document number: NP-SANTEN-EMEA-0223
Date of preparation: August 2021