Spark Therapeutics presents analyses from Phase 3 trial of Luxturna

Spark Therapeutics announced findings from three post-hoc analyses of data from the Phase 3 clinical trial of LUXTURNA at the American Academy of Ophthalmology Annual Meeting in Chicago. 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. 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 visual acuity improvement averaged over both eyes for participants in the intervention group was not statistically significant as compared to the control group 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. No adverse events associated with a reduction in visual acuity have been reported across the LUXTURNA clinical development program. In the post-marketing setting, one adverse event of reduced visual acuity has been reported within the immediate post-operative period following administration. It was considered non-serious and is reported to be resolving.
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