The therapy is administered as a single subretinal injection beneath the retina in patients with confirmed RPE65 mutations and viable retinal cells. LUXTURNA was developed and commercialized in ...

Also under review in Europe, Luxturna is a single injection of a genetically engineered virus expressing the retinal pigment protein that is deficient in people with the condition. While the FDA ...

LUXTURNA has significant market potential due to the high unmet need for effective treatments in rare genetic conditions. With its FDA approval for specific mutations in the RPE65 gene, it offers ...

In December 2017, the US Food & Drug Administration (FDA) approved Luxturna from Spark Therapeutics — the first gene therapy to win market approval in the US. Several other gene therapy programs ...