HIGHLIGHTS OF PRESCRIBING INFORMATION

1 INDICATIONS AND USAGE: LUXTURNA is an adeno-associated virus vector-based gene therapy indicated for the treatment of patients with confirmed biallelic RPE65 mutation-associated retinal dystrophy.

2 DOSAGE AND ADMINISTRATION: For subretinal injection only. The recommended dose is 1.5 x 10^11 vector genomes (vg) of LUXTURNA, in a total volume of 0.3 mL, administered to each eye on separate days, at least 6 days apart. A course of oral corticosteroids is required prior to and after administration.

5 WARNINGS AND PRECAUTIONS: 
- Endophthalmitis, Retinal Tears, and Retinal Detachment: Use aseptic technique. Monitor patients for signs of infection and tears post-injection.
- Increased Intraocular Pressure: Monitor and manage IOP.
- Cataract: Cataract formation or progression has been observed.

6 ADVERSE REACTIONS: The most common adverse reactions (incidence ≥5%) were conjunctival hyperemia, cataract, increased intraocular pressure, retinal tear, dellen, macular hole, subretinal deposits, eye inflammation, eye irritation, eye pain, and maculopathy.

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