This section contains the draft artwork for the carton and container labels for both LUXTURNA concentrate and the diluent. Concentrate Vial Label Text: - Product Name: LUXTURNA™ (voretigene neparvovec) - Strength: 5 x 10^12 vector genomes (vg)/mL - Contents: 0.5 mL extractable volume in a 2 mL vial - Route: For Subretinal Injection After Dilution - Storage: Store at ≤ -65°C - Other: Single-Dose Vial. Discard Unused Portion. Rx only. Diluent Vial Label Text: - Product Name: Diluent for LUXTURNA™ - Contents: 1.7 mL extractable volume in a 2 mL vial - Route: For dilution of LUXTURNA™ concentrate only. Not for direct injection. - Storage: Store at 2°C to 8°C (36°F to 46°F). - Other: Single-Use Vial. Sterile. Outer Carton Text: Includes all information from vial labels, plus kit contents (1 vial of concentrate, 2 vials of diluent), NDC number, and manufacturer information (Spark Therapeutics, Inc.).