{"id":62082,"date":"2025-10-24T01:06:20","date_gmt":"2025-10-23T23:06:20","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/sydnexis-receives-complete-response-letter-from-fda-for-syd-101-to-slow-pediatric-myopia-progression\/"},"modified":"2025-10-24T01:06:20","modified_gmt":"2025-10-23T23:06:20","slug":"sydnexis-receives-complete-response-letter-from-fda-for-syd-101-to-slow-pediatric-myopia-progression","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/sydnexis-receives-complete-response-letter-from-fda-for-syd-101-to-slow-pediatric-myopia-progression\/","title":{"rendered":"Sydnexis Receives Complete Response Letter from FDA for SYD-101 to Slow Pediatric Myopia Progression"},"content":{"rendered":"
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DEL MAR, Calif.–(BUSINESS WIRE)–Sydnexis, Inc., (www.sydnexis.com<\/a>), a biopharmaceutical company focused on pediatric progressive myopia (PPM), today announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter (CRL) for the New Drug Application (NDA) for SYD-101, a proprietary 0.01% atropine formulation developed with enhanced ocular delivery characteristics and room-temperature stability to slow the progression of pediatric myopia in children.<\/p>\n

\nSydnexis\u2019 NDA for SYD-101 was supported by the results of the Phase 3 STAR (Study of Atropine for the Reduction of Myopia Progression) trial, the largest global clinical program completed to date in pediatric myopia, which evaluated more than 800 children aged 3-14 at treatment initiation. The study met its primary efficacy endpoint of proportion of patients with confirmed progression of -0.75D, which FDA had encouraged the Company to use. A key secondary endpoint, annual progression rate, also met statistical significance at 12, 24, and 36 months. Furthermore, in a subgroup of fast progressors [more than -0.5D\/yr] at 36 months, SYD-101 demonstrated statistically significant treatment effects of a reduction in progression of more than 50%.<\/p>\n

\nThe FDA acknowledged in the complete response letter (CRL) that this 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.<\/p>\n

\n\u201cWhile we are surprised and disappointed with this decision, Sydnexis is committed to working with the FDA to address the items outlined in the CRL and determining the best path forward toward approval for SYD-101,\u201d said Perry Sternberg, Chief Executive Officer of Sydnexis. \u201cOur goal is to provide eye care professionals in the U.S. with the first FDA-approved option to help slow the progression of pediatric myopia, rather than continued reliance on compounded formulations of atropine. 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.\u201d<\/p>\n

\nSYD-101 is currently approved in the European Union, where it is licensed to Santen S.A. and marketed as Ryjunea\u00ae.<\/p>\n

\nAbout SYD-101<\/b><\/p>\n

\nSYD-101 is a proprietary low-dose atropine formulation developed to slow the progression of pediatric progressive myopia. It features several novel attributes designed to optimize tolerability, stability, and clinical performance:<\/p>\n