# Groundbreaking AAV-based gene therapy offers potential treatment for patients with OTOF gene-associated severe-to-profound and profound hearing loss.

*biotech · news · 2026-04-24 · The Manila Times*

## Key points

- The FDA approved Otarmeni, the first-ever dual AAV vector-based gene therapy for OTOF-related hearing loss.
- Otarmeni approval was granted just 61 days after BLA filing, tying the fastest in FDA history.
- Eighty percent of evaluable pediatric patients showed improved hearing after Otarmeni treatment in clinical trials.
- Otarmeni is a one-time, surgically administered biologic-device combination delivering OTOF gene via dual AAV1 vectors.
- Otarmeni is the first gene therapy approved under the Commissioner's National Priority Voucher pilot program.

**Companies:** Regeneron Pharmaceuticals, Inc.
**Countries:** United States

[Read the full story on The Manila Times](https://www.manilatimes.net/2026/04/24/tmt-newswire/globenewswire/fda-approves-first-ever-gene-therapy-for-treatment-of-genetic-hearing-loss-under-national-priority-voucher-program/2327730)

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