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May 2, 2019

Sydnexis Announces First Patients in Phase 3 Clinical Trial

Sydnexis Announces Enrollment of First Patients in Phase 3 Myopia STAR Study of SYD-101 in Children

SAN DIEGO, CA., May 2, 2019 (PRNewswire)—Sydnexis Inc., a privately held clinical stage biopharmaceutical company developing a proprietary formulation for decreasing myopic progression in children, announced that the first patients have been successfully dosed in a Phase III multi-center trial of SYD-101, following FDA clearance of Sydnexis’ IND in April. Sydnexis’ STAR Study will be the largest myopia study initiated to date with more than 800 patients. In a placebo controlled trial the STAR Study will test the safety and efficacy of two dosage strengths of SYD-101, the company’s patented investigational drug, as a first-line therapy to slow the rate of myopic progression in children.

Myopia (nearsightedness) is a common vision condition in which you can see objects up close clearly, but distant objects appear blurry. The prevalence of myopia is on the rise and projections suggest almost 50% of the world’s population will be myopic by 2050. Currently, there are no approved pharmaceutical treatments to slow the progression of myopia in the US and Europe. While symptoms of myopia in children can be corrected by using prescription glasses or contact lenses, the underlying disease is not controlled by glasses or contact lenses. The steady progression of myopia over time can result in high myopia and significantly increases one’s risk of retinal detachment, retinal atrophy, choroidal neovascularization, glaucoma, cataracts, and blindness.2

Commercially available atropine (1.0% and 0.5%) has been tested and shown to be effective in treating the progression of myopia, however these high doses have an elevated incidence of adverse events that typically result in discontinuation of treatment. Lower dose (0.01%) atropine has been shown in numerous academic studies to reduce the incidence of adverse events while maintaining virtually the same efficacy as 1% atropine.

A product containing 0.01% atropine has not yet been approved by the FDA and compounded 0.01% atropine can be pharmacologically unstable. Significant degradation after 3 months at room temperature has been observed in compounded formulations resulting in a product with a short shelf life, and possibly posing issues for regulatory agencies, health care professionals, and most importantly patients.

SYD-101 uses Sydnexis’ proprietary technology, was designed for maximum stability and tolerability, and will be dosed nightly as a single drop in each eye. “We are very excited to be developing a drug [SYD-101] to help address this global epidemic in children. Myopia has been, to a large extent, ignored by the pharmaceutical industry,” stated Dr. Kenneth Widder, M.D. Chief Executive Officer of Sydnexis. “We have reformulated a well-known drug that has shown to be effective in academic clinical trials into a proprietary formulation with a long shelf life.”

Sydnexis is actively enrolling patients at multiple sites. “We are excited that Sydnexis has decided to pursue a treatment for progressive myopia,” said Dr. Darren Bell from the Medical Center Ophthalmology Associates of San Antonio, Texas, “There are millions of children in the United States that suffer from this condition and many of them could greatly benefit from the availability of a well-tolerated, stable FDA-approved drug.”

About the STAR Study
The STAR study is a multi-center, randomized, double masked, placebo-controlled trial evaluating two dosage strengths of SYD-101 in more than 800 children between the ages of 3-14.

About Sydnexis Inc.
Sydnexis Inc. is a venture backed, clinical stage ophthalmic biopharmaceutical company focusing exclusively on its patent protected formulation of low dose atropine to enhance the lives and improve myopic progression in children with progressive myopia.

Patrick Johnson, Ph.D.
Chief Business Officer
P: (858) 925-6172

1 Holden, BA, et al. 2016. Global prevalence of myopia and high myopia and temporal trends from 2000 through 2050. Ophthalmology 123(5): 1036-1042.
2 Verhoeven, VJM, et al. 2015. Visual Consequences of refractive errors in the general population. Ophthalmology 122(1): 101-109.