A 6-Month Extension Study of OTO-104 in Meniere's Disease

A 6-Month, Multicenter, Phase 3, Open-Label Extension Safety Study of OTO-104 Given At 3-Month Intervals by Intratympanic Injection in Subjects With Unilateral Meniere's Disease

This is an open-label extension study of a single intratympanic injection of OTO-104 given every 3 months for a total of 2 injections. Subjects must have completed either Otonomy study 104-201403 (1-Year, Phase 2, Safety Study of OTO-104) or 104-201508 (Phase 3 Study of OTO-104) in order to be eligible for this open-label extension study.

Inclusion Criteria includes, but is not limited to:

• Subject has completed the Phase 2 OTO-104 1-Year Safety Study (104-201403) or Phase 3 (104-201508) clinical study.
• Subject has a diagnosis of definite unilateral Meniere's disease by 1995 AAO-HNS criteria

Exclusion Criteria includes, but is not limited to:

• Subject is pregnant or lactating.
• Subject has a history of immunodeficiency disease.
• Subject has experienced an adverse reaction to intratympanic injection of steroids.