THANK YOU FOR SUBSCRIBING
Pharma Tech Outlook Weekly Brief
Be first to read the latest tech news, Industry Leader's Insights, and CIO interviews of medium and large enterprises exclusively from Pharma Tech Outlook
Nick Ruth, Chief Commercial OfficerAccording to a report published by Stanford Medicine, over 40 percent of children in the U.S. suffer from progressive myopia. The prevalence is even higher in Asia, where approximately 60 percent of the youth is affected by this condition. Despite these staggering numbers, there remains a lack of non-invasive FDA-approved pharmaceutical treatments capable of slowing this eye disorder’s progression.
A clinical-stage biopharmaceutical company, Sydnexis, is at the forefront of bridging this gap. With its innovative investigational drug, SYD-101, it aims to offer a significant breakthrough in addressing the unmet need to treat progressive myopia in children.
Progressive myopia, if not managed properly, poses a serious risk in the coming decades, surpassing cataracts as a leading cause of global blindness. This urgency brings the relevance of SYD-101 into even sharper focus.
Its patented eye drop formulation aims to revolutionize ocular pharmacology, representing a significant evolution from conventional aqueous-based eye drops.
Presently, a low-dose atropine based, non-FDA-approved, eye drop is what doctors have had to use. This low-dose atropine, can face stability challenges in aqueous solutions where the active ingredient is prone to degradation through hydrolysis, transforming atropine into inactive tropic acid. To combat this stability challenge, solutions are usually adjusted to a lower pH, often, at or less than four. However, this acidic solution can cause discomfort, especially for children.
SYD-101 addresses this issue, with its proprietary formulation, by stabilizing atropine, at a neutral physiological pH, close to seven. This innovative approach enhances the drug’s bioavailability and penetration, while avoiding the stinging and discomfort associated with acidic solutions, offering a more patient-friendly treatment option for children with progressive myopia.
Highlighting its advantage, Nick Ruth, Chief Commercial Officer of Sydnexis, says, “Our formulation is designed to overcome the challenges associated with this complex compound. SYD-101 sets a new industry benchmark, offering a stable and dependable option and positioning as the premium low dose atropine pharmaceutical.”
SYD-101 is now at a crucial point in its Phase III FDA clinical trial, known as the STAR study. This study is the largest prospective treatment study in myopia. It aims to rigorously assess the effectiveness of two dosages of SYD-101 and a placebo in slowing myopic progression in children.
Underpinning Sydnexis’s ambitious project is a team with formidable industry acumen, coupled with a multidisciplinary medical advisory board comprising pediatric ophthalmologists, general ophthalmologists, optometrists, and orthoptists. This synergy of expertise forges an impressive front in clinical research, adding a layer of comprehensive insight into the development process.
In the current landscape, where an FDA-approved medication to curb the progression of myopia remains elusive, SYD-101 is a progressive pivot that could affect millions of children. It stands on the precipice of introducing a treatment that may not only change clinical practice but significantly enhance the quality of life for countless children affected by progressive myopia and reduce comorbidities later in life.
Company
Sydnexis
Management
Nick Ruth, Chief Commercial Officer and Patrick Johnson PhD, President of Sydnexis
Description
Sydnexis has carved a prominent place in the biotech and pharmaceutical arena by taking on the formidable challenge of developing a groundbreaking treatment for the massive and growing unmet need of progressive myopia in children and reducing the risk of serious comorbidities later in life.
DEL MAR - Sydnexis, Inc., (www.sydnexis.com) a pre-commercial stage biopharmaceutical company focused on the treatment of progression of pediatric myopia, is excited to announce the appointment of Perry J. Sternberg as Chief Executive Officer and as a member of the Board of Directors. An accomplished pharma/biotech executive with over 30 years in the industry and 15 years in eye care, Perry will provide invaluable leadership experience to help guide Sydnexis’ strategic direction and next phase of growth.
“Perry’s appointment comes at a pivotal time for Sydnexis as we continue to advance our lead asset, SYD-101, to slow the progression of pediatric myopia and the risk of associated co-morbidities,” said Jeffry Weinhuff, Managing Partner at Visionary Venture Fund and Lead Board Director at Sydnexis. “Perry has deep expertise in commercialization of new therapies across diverse markets and extensive experience leading organizational growth and transformation. He will be a tremendous asset to Sydnexis.”
Perry 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, which generated nearly $10 billion of revenue annually. Perry 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. Perry was a key member of the leadership team responsible for the sale of Shire to Takeda in January 2019 at an aggregate value of more than $62 billion. Subsequently, the successful launch of Xiidra led to its sale by Takeda to Novartis in May 2019 in a transaction valued at greater than $5 billion.
“Progression of pediatric myopia is a global epidemic that poses significant risk for developing many irreversible, sight-threatening co-morbidities later in life,” said Richard Lindstrom, M.D., founder, director and attending surgeon at Minnesota Eye Consultants P.A. and member of the Sydnexis Board of Directors. “With the recent three-year readout of the primary and secondary endpoints of the Phase 3 STAR trial, I’m thrilled about Perry’s appointment as CEO and the bright future ahead for Sydnexis.”
“The Sydnexis team has an industry-leading track record in eye care. I am excited to join and work with Patrick Johnson, President, and the rest of the management team,” said Perry Sternberg. “Progression of pediatric myopia is a serious condition with significant, growing unmet need and no FDA-approved pharmacological treatment options. I look forward to collaborating with this talented team to bring such an innovative treatment option like SYD-101 to pediatric patients, their families, and clinicians.”
Perry Sternberg will join Sydnexis on August 5. Immediately prior to joining Sydnexis, Perry served as President and Chief Executive Office of Corium, LLC. He transformed the company from a transdermal contract manufacturing and development business (CDMO) to a market-leading commercial CNS (central nervous system) therapeutics company. Under his leadership, Corium received FDA approval for and commercially launched two novel CNS therapies, AZSTARYS® and ADLARITY®. Perry’s decades of industry experience have focused on exceeding the needs of customers and patients. A hallmark of his career is his proven ability to effectively lead teams and bring out their optimal performance while successfully managing significant change.