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December 16, 2024
Photo Credit: Shutterstock
Privately held, clinical-stage pharmaceutical company, Sydnexis Inc. has recently completed an evaluation of its patented low-dose atropine formulation, SYD-101, in a Pivotal Phase 3 clinical trial. Based in San Diego and founded in 2014, Sydnexis recently named Perry J. Sternberg Chief Executive Officer.
Dwight Akerman, OD, MBA, Chief Medical Editor of Review of Myopia Management, interviewed Sternberg to learn more about the company and its therapeutic focus on the clinical development of ophthalmic treatments for disease states with limited treatment options. Learn more about Sydnexis and its eye drop formula in their following discussion.
RMM: As the new CEO of Sydnexis, what is your vision for the company and its patented eye drop formulation, SYD-101?
Sydnexis: I’ve spent about half of my 30+-year career in the eye care industry, and there couldn’t have been a better opportunity to return to the therapeutic area than joining Sydnexis as CEO. Sydnexis was founded to develop a pharmacological treatment option to slow the progression of pediatric myopia. This serious condition has a significant, growing unmet need, and unfortunately, no approved pharmacological treatment options exist.
Sydnexis is at a critical inflection point in its journey with its lead asset, SYD-101. This innovative pharmacological treatment will potentially be the first and only FDA-approved pharmacological treatment option to slow the progression of pediatric myopia and minimize the risk of comorbidities. As we continue to advance SYD-101, we’re also shifting from a clinical-stage company to a pre-commercial-stage company. I’m excited to work with the management team and Board of Directors to build upon Sydnexis’ achievements and help guide this next phase of growth.
RMM: Why did Sydnexis choose to study topical low-dose atropine, specifically its proprietary formulation SYD-101, as an intervention for juvenile-onset myopia?
Sydnexis: Pediatric myopia is the most common eye disease in children, affecting about 27 million in the U.S., and its prevalence has dramatically increased over the last 30 years. While it was once considered a benign refractive condition, it’s now well understood that myopia is associated with multiple serious, irreversible, sight-threatening comorbidities later in life. Yet, despite its global burden and growing unmet need, there are currently no FDA-approved pharmacological treatment options.
Sydnexis recognized this growing unmet need and the potential benefit of a highly differentiated, broadly accessible, and FDA-approved pharmacological treatment option. While low-dose atropine is available in the U.S. through compounding pharmacies, it is not FDA-approved and presents challenges and concerns for clinicians and parents of children with pediatric progressive myopia.
Sydnexis’ proprietary formulation SYD-101 is novel in ophthalmology and can address existing challenges with compounded atropine attributed to it being highly unstable in aqueous solutions. The SYD-101 formulation could be the first highly stable form of atropine at a physiologically neutral pH, thereby potentially providing additional benefits, including improved penetration and comfort. It is also possibly the first eye drop with a three-year shelf life. We’re excited about the innovation that SYD-101 provides and the chance to provide a highly differentiated, broadly accessible, and FDA-approved pharmacological treatment option in the future.
RMM: Please explain the U.S. regulatory pathway for SYD-101.
Sydnexis: I am excited to share with you that Sydnexis has completed the third year of its Phase 3 STAR study. This landmark study is the largest ever conducted for the treatment of pediatric myopia progression. I congratulate the entire Sydnexis team on this major accomplishment! With the third year completed, we are focused on submitting our U.S. NDA and bringing SYD-101 to market as soon as possible.
RMM: What commercial partnerships has Sydnexis established to date? Does Sydnexis expect to establish additional commercial partnerships in the future?
Sydnexis: We are thrilled to partner with Santen for the future commercialization and launch of SYD-101 in Europe. Santen is one of the world’s leading specialist ophthalmic pharmaceutical companies, with a strong reputation and track record in the European market. The Santen team will be a great partner so that SYD-101 can be an option for more pediatric patients living with progressive myopia globally.
In parallel to working toward our U.S. NDA submission for SYD-101, we are actively planning for Sydnexis’ next phase of growth. I’m excited to have the opportunity to help guide our strategic direction as we shift to a pre-commercial stage company, and I look forward to sharing more about what that looks like in the near future.
RMM: If approved, how do you envision SYD-101 to fit into U.S. eye care professionals’ toolbox for treating juvenile-onset myopia? Describe the opportunity.
Sydnexis: With most complex and progressive diseases, physicians consider all the options available to them. We expect that pediatric progressive myopia will be no different because the end goal is to help slow the progression of the disease to the best degree possible. We believe that, if approved, SYD-101 can be the foundation of treatment as the first and only pharmacological option to slow the progression of pediatric myopia. Our pivotal Phase 3 STAR Study enrolled over 850 patients between the ages of 3 and 14 years and could be the only treatment option approved for patients under the age of 8.
We expect physician-directed optical treatments, which include premium medical devices such as next-generation spectacles and specialty contact lenses for myopia, to complement SYD-101. Numerous published studies show that these devices, when combined with low-dose atropine, can have additive benefits. In addition, behavior modification, such as outdoor play and limiting time on devices such as cell phones, will continue to be important and a part of the multi-pronged approach to treating pediatric progressive myopia.
SYD-101 offers an exciting opportunity as a new, innovative treatment option, and I look forward to collaborating with the talented team at Sydnexis to bring it to market for pediatric patients, their families, and clinicians.
RMM: Thank you for sharing your insights on the future of Sydnexis and its SYD-101 formulation, which is under clinical development for childhood myopia.
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Perry Sternberg brings to Sydnexis over 30 years of commercial leadership, including oversight of more than 20 product launches across a wide range of therapeutic areas and markets. His tenure in eye care spans 15 years across Novartis, Bausch & Lomb, and Shire, where he was responsible for the U.S. commercial organization and managing the company’s product portfolio in five franchises. He led the build-out of the Ophthalmic business unit and launch of Xiidra in 2016, the first FDA-approved treatment for the signs and symptoms of dry eye disease. He was a key member of the leadership team responsible for the sale of Shire to Takeda in January 2019, and subsequently, the successful launch of Xiidra led to its sale by Takeda to Novartis in May 2019. |
