Abstract
Lunsotogene parvec (Otarmeni – Regeneron), an adeno-associated viral vector-based gene therapy, has received accelerated approval from the FDA for treatment of severe-to-profound or profound sensorineural hearing loss (any frequency >90 decibels hearing level [dB HL]) in patients with confirmed variants in both copies of the otoferlin (OTOF) gene. It is the first gene therapy to be approved in the US for genetic hearing loss.