Application for Branded Atropine Drug Rejected by FDA

Sydnexis said in a statement that it remains confident in its data and will work with the FDA to address concerns that might allow for an eventual approval of SYD-101. Photo: Getty Images. Click image to enlarge. Prescribing topical atropine is a popular intervention to reduce myopic progression, but it will have to remain an off-label practice in the United States for now. Last Thursday, the FDA rejected an application from Sydnexis for its drug candidate, code-named SYD-101.The drug, a 0.01% formulation of atropine, was tested on over 800 subjects in the Study of Atropine for the Reduction of Myopia Progression (STAR) Phase III clinical trial. The STAR trial data have not yet been published, though the company has shared some top-line findings. A Sydnexis press release said that the study met its primary efficacy endpoint, as well as a secondary one concerning annual progression rate, including statistically significant treatment effects in a subgroup of fast progressors.Primary endpoint was the proportion of participants with myopic progression -0.75D at months 12, 24 and 36, “which FDA had encouraged the Company to use,” Sydnexis said in its press release commenting on the FDA’s response letter.The text of the FDA’s letter has not been made public. According to the Sydnexis statement characterizing it, the FDA acknowledged that the primary endpoint was met “but stated its view that the data do not support the effectiveness of low-dose atropine in children with myopia.” No deficiencies were noted related to safety or product quality, Sydnexis said.The company said it is “surprised and disappointed” by the decision but is “committed to working with the FDA” to address the issues it raised in hopes of determining a path forward for SYD-101. “We remain confident in our data and the potential of SYD-101 to fill a critical innovation gap and treat the most common eye disease in children,” said Perry Sternberg, Chief Executive Officer of Sydnexis, in the statement.The company also pointed out that SYD-101 would improve upon compounded atropine formulations by providing a shelf-stable product with a “near-neutral” pH for better patient tolerability. This article was developed by the editorial staff in conjunction with experts in the field. In the process, AI may have been among the editorial tools used to meet the goals of human editors, who approved all content.