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Spark Therapeutics Announces Presentation of Additional Phase 3 Data on SPK-RPE65 at The American Academy of Ophthalmology 2015 Annual Meeting

Spark Therapeutics, Inc. (NASDAQ:ONCE) announced today 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 Sparks 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 a mean improvement of approximately two lines (9.0 letters averaged across both eyes) on the logarithm of the minimum angle of resolution (logMAR) scale, a standard measure of visual acuity, compared with a slight improvement (1.6 letters) among control subjects.

Over one-third of the intervention subjects (seven of 20) saw a 15-letter, or three-line, improvement in the first eye administered, compared with none in the control group. In the second eye administered, four of 20 intervention subjects reached a 15-letter improvement compared with none of the control subjects. Spark continues to conduct analyses of the changes seen in visual acuity.

In addition to highly statistically significant results seen in the primary and first two secondary endpoints, it is also encouraging to see the positive trends in visual acuity, which measures a persons central vision, Dr. Maguire said. The main effect of SPK-RPE65 involves rod-mediated...


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