5 Key Takeaways

• 1

  The FDA has granted accelerated approval for lunsotogene parvec-cwha to treat severe-to-profound sensorineural hearing loss due to OTOF gene variants.

• 2

  The therapy uses an adeno-associated virus vector to deliver a functional OTOF gene copy to cochlear hair cells, aiming to restore hearing.

• 3

  In the Phase 1/2 CHORD trial, 16 of 20 patients improved to 70 decibels or better at 24 weeks, indicating significant hearing restoration.

• 4

  The therapy is not recommended for patients with prior cochlear implants or those without accessible inner ear access.

• 5

  Adverse events included otitis media and dizziness, with surgical risks such as meningitis and facial nerve complications.