Spark Therapeutics Presents Three Post-hoc Analyses from Phase 3 Clinical Trial of LUXTURNA

Spark Therapeutics (NASDAQ:ONCE), a fully integrated, commercial gene therapy company dedicated to challenging the inevitability of genetic disease, today announced findings from three post-hoc analyses of data from the Phase 3 clinical trial of LUXTURNA (voretigene neparvovec-rzyl) at the American Academy of Ophthalmology Annual Meeting in Chicago.

As quoted in the press release:

LUXTURNA is a one-time gene therapy for the treatment of patients with vision loss due to inherited retinal dystrophy caused by confirmed biallelic RPE65 mutations and viable retinal cells. One of these analyses will be the subject of the oral presentation, “Visual Acuity Outcomes in the Voretigene Neparvovec Phase 3 Trial” today at 3:51pm CT in room S405 at McCormick Place in Chicago.

In the Phase 3 clinical trial of LUXTURNA, visual acuity was measured using a scale adapted from the Holladay method, which assigns LogMAR values for off-chart vision measurements. Best-corrected (with optimal glasses/contact lens prescription) visual acuity improvement averaged over both eyes for participants in the intervention group was not statistically significant as compared to the control group (p=0.17) at year one. In this post-hoc analysis, visual acuity data were revisited using the Lange method, which is a less conservative off-chart vision scale when quantifying the difference between counting fingers and hand motions. Results at year one using this method showed a statistically significant improvement from baseline versus the control group in best-corrected visual acuity averaged over both eyes (nominal p<0.05).

Click here to read the full press release.