Regeneron's Otarmeni became the first FDA-approved gene therapy for hereditary hearing loss caused by OTOF gen! Swipe to see →
On April 23, 2026, the FDA granted full approval to Otarmeni (DB-OTO), Regeneron's gene therapy for hereditary deafness caused by mutatio...
The inner ear contains approximately 15,000 specialized cells called hair cells — sensory cells that convert sound vibrations into electr...
Otarmeni delivers a functional copy of the OTOF gene directly to the cochlear hair cells using an adeno-associated virus (AAV1) vector — ...
The CHORD trial enrolled children ages 1-6 with confirmed OTOF gene mutations and bilateral profound deafness. The primary endpoint was h...
The Otarmeni approval matters far beyond the specific population of children with OTOF mutations.
Regeneron is already in trials for gene therapies targeting other genetic causes of hearing loss. Several academic medical centers are in...
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