Spark Therapeutics, Inc. hereby claims Orphan Drug Exclusivity for LUXTURNA for the treatment of retinal dystrophy due to biallelic RPE65 mutations (Orphan Designations #08-2593, #15-4927, #16-5744). Additionally, upon approval, Spark Therapeutics, Inc. will be eligible for and requests the issuance of a Rare Pediatric Disease Priority Review Voucher, as this BLA for a rare pediatric disease is being approved.