Luxturna (Voretigene Neparvovec-Rzyl)

Prescription medicineOnly Available By Prescription

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Description

Luxturna (voretigene neparvovec-rzyl) is a gene therapy indicated for the treatment of patients with confirmed biallelic RPE65 mutation-associated retinal dystrophy who have sufficient viable retinal cells. It is the first FDA-approved in vivo gene therapy for a genetic disease, designed to deliver a functional copy of the RPE65 gene directly to retinal cells via subretinal injection. By restoring RPE65 enzyme activity, Luxturna enables the visual cycle to resume, improving visual function and potentially slowing further vision loss. The therapy is used in pediatric and adult patients with inherited retinal diseases leading to progressive vision loss and, in many cases, blindness.

Fact Table

Formula

Not applicable (gene therapy vector)

License

US FDA (2017)

Bioavailability

Not applicable (localized ocular delivery)

Legal status

Prescription only

Chemical Name

Voretigene Neparvovec-rzyl

Elimination half-life

Not formally determined (non-systemic therapy)

Dosage (Strength)

1.5 × 10¹¹ vector genomes/0.3 mL per eye

Pregnancy

Use only if clearly needed – no human data

Brands

Luxturna

Protein binding

Not applicable

PubChem CID

119531215

MedlinePlus

a619047

ChEBI

N/A

ATC code

S01XA27

DrugBank

DB13919

KEGG

D11030

Routes of administration

Subretinal injection

Directions

Luxturna is administered as a one-time subretinal injection to each eye, separated by at least 6 days between treatments. The recommended dose is 1.5 × 10¹¹ vector genomes per eye, administered by a retinal surgeon in a specialized surgical center. Patients should receive systemic corticosteroids (e.g., oral prednisone 1 mg/kg/day, up to 40 mg/day) for 7 days before and for 10 days after the injection, followed by tapering over the next 10 days. Proper diagnosis via genetic testing to confirm biallelic RPE65 mutations is required before treatment.

Ingredients

Each 1.5 mL vial of Luxturna contains:

  • Voretigene neparvovec-rzyl (1.5 × 10¹² vector genomes/mL), an adeno-associated virus vector carrying the human RPE65 gene
  • Excipients include:
  • Sodium chloride, sodium phosphate monobasic and dibasic, magnesium chloride, poloxamer 188, sucrose, and water for injection

Luxturna is a preservative-free product and must be stored at =–65°C until use. Thaw and prepare under sterile conditions immediately before administration.

Contraindications

Luxturna is contraindicated in patients with:

  • Ocular or periocular infections
  • Active intraocular inflammation

Cautions

Careful assessment of retinal structure via optical coherence tomography (OCT) is required to determine retinal viability. Use of Luxturna in patients with advanced retinal degeneration may not be beneficial. Subretinal administration carries surgical risks including retinal tears, detachment, or macular holes. Patients should be advised to avoid air travel or high-altitude exposure until intraocular air bubbles resolve. There is a theoretical risk of vector shedding; contact precautions are advised for bodily fluids for a short period following treatment. Use in pregnancy has not been studied; contraception is recommended for females of reproductive potential.

Side Effects

Common and potential side effects include:

  • Ocular inflammation
  • Elevated intraocular pressure
  • Cataract formation
  • Retinal tear or detachment
  • Maculopathy
  • Dellen (localized corneal thinning)
  • Eye pain or discomfort
  • Rare: endophthalmitis, irreversible vision loss

IMPORTANT NOTE: The information provided above is for general awareness and educational purposes only. It is not intended to diagnose, treat, or replace professional medical or veterinary advice. Always consult your physician, pharmacist, or veterinarian regarding the safety, suitability, and proper use of any medication for yourself or your pet.

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