The drug product, LUXTURNA, is a sterile, single-dose suspension for subretinal injection. It is supplied as a frozen concentrate in a 2 mL single-dose vial containing an extractable volume of 0.5 mL at a nominal concentration of 5 x 10^12 vector genomes (vg)/mL. It must be thawed and diluted 1:10 prior to administration using the supplied Diluent, which is provided in two 2 mL vials. The final diluted product for administration has a concentration of 1.5 x 10^11 vg per 0.3 mL. The drug product is formulated in a buffered saline solution with 0.001% poloxamer 188 to prevent aggregation and surface adsorption. The final product is tested for sterility, purity, identity, potency, and other critical quality attributes.