Sydnexis announced that the first patients have been successfully dosed in a phase 3 multicenter trial of SYD-101, following FDA clearance of Sydnexis’ IND in April. Sydnexis’ STAAR study will be the largest myopia study initiated to date with more than 800 patients. In a placebo controlled trial the STAAR 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.
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, according to Sydnexis.
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,” Kenneth Widder, MD, Chief Executive Officer of Sydnexis, said in a company news release. “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,” Darren Bell, MD, from the Medical Center Ophthalmology Associates of San Antonio, Texas, said in the news release. “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 STAAR Study
The STAAR 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.