Spark Therapeutics Presents Additional Phase 3 Data on SPK-RPE65 at The American AAO 2015 Annual Meeting

Spark Therapeutics, Inc. ONCE announced Saturday, that additional secondary endpoint data from the Phase 3 pivotal trial of SPK-RPE65 were presented at the American Academy of Ophthalmology (AAO) 2015 Annual Meeting. SPK-RPE65 is Spark's lead product candidate for the treatment of RPE65-mediated inherited retinal dystrophies. As previously announced, the randomized controlled multicenter Phase 3 trial demonstrated a highly statistically significant improvement in the intervention group compared to the control group in the primary endpoint, the change in bilateral mobility testing (MT) between baseline and one year. The first two secondary endpoints – full-field light sensitivity threshold testing (FST) and MT for the assigned first eye – also showed highly statistically significant improvement. Principal Investigator Albert M. Maguire, MD, professor of ophthalmology at the Perelman School of Medicine of the University of Pennsylvania, presented a comprehensive overview of results at AAO, including new detail highlighting the positive trends seen in the third secondary endpoint, visual acuity. These data showed that intervention subjects in the modified intent-to-treat efficacy analysis population achieved See full press release
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