LUXTURNA is a sterile concentrate for solution for subretinal injection. It is a suspension supplied in a single-dose 2 mL vial containing an extractable volume of 0.5 mL. The concentrate has a nominal concentration of 5 x 10^12 vector genomes (vg)/mL. The accompanying Diluent is a sterile solution supplied in two 2 mL vials. Prior to use, the concentrate is diluted 1:10 with the Diluent to yield a final dose of 1.5 x 10^11 vg in a deliverable volume of 0.3 mL.
Composition of Concentrate and Diluent:
- Active Ingredient: voretigene neparvovec
- Excipients: Sodium Chloride, Sodium Phosphate (dibasic and monobasic), Poloxamer 188, and Water for Injection. The pH is adjusted to 7.3.