Last month, Sydnexis, a biopharmaceutical company developing pediatric progressive myopia (PPM) treatments, announced a complete response letter (CRL) from the FDA regarding its new drug application (NDA) for SYD-101, a proprietary 0.01% atropine formulation primarily intended for slowing the pediatric myopia in children aged around 3–14 years. The NDA was supported by phase III result from the STAR (Study of Atropine for the Reduction of Myopia Progression) trial, a randomized, double-masked, multi-center study which enrolled approximately 847 children with myopia in the range of around –0.50 D to –6.00 D.
In Europe, the European Medicines Agency (EMA) granted a positive CHMP (Committee for Medicinal Products for Human Use) opinion for the candidate based on the STAR trial data, which met its primary efficacy endpoint of proportion of participants with myopic progression worse than –0.75 D, as well as the mean annual progression rate of myopia (spherical equivalent) over the treatment period.
While the CRL acknowledged that SYD-101 had met its primary endpoint and there were no safety concerns, it added that it believes the data still does not support the efficacy of low-dose atropine as a treatment for children with myopia.
“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,” Perry Sternberg, Chief Executive Officer of Sydnexis, stated. “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.”
In Europe, SYD-101 is currently marketed under the brand name Ryjunea® by Santen.
Source: Business Wire
In Europe, the European Medicines Agency (EMA) granted a positive CHMP (Committee for Medicinal Products for Human Use) opinion for the candidate based on the STAR trial data, which met its primary efficacy endpoint of proportion of participants with myopic progression worse than –0.75 D, as well as the mean annual progression rate of myopia (spherical equivalent) over the treatment period.
While the CRL acknowledged that SYD-101 had met its primary endpoint and there were no safety concerns, it added that it believes the data still does not support the efficacy of low-dose atropine as a treatment for children with myopia.
“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,” Perry Sternberg, Chief Executive Officer of Sydnexis, stated. “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.”
In Europe, SYD-101 is currently marketed under the brand name Ryjunea® by Santen.
Source: Business Wire
