Open Label Study of OTO-104 in Subjects With Meniere's Disease

A 1-Year, Phase 2, Open-Label Safety Study of OTO-104 Given at 3-Month Intervals by Intratympanic Injection in Subjects With Unilateral Meniere's Disease

This is a 1-year, multicenter, Phase 2, open-label safety study in subjects with unilateral Meniere's disease. Subjects will receive 1 intratympanic (IT) injection of 12 mg OTO-104 at 3-month intervals for a total of 4 injections total.

Inclusion Criteria includes, but is not limited to:

• Subject has a diagnosis of definite unilateral Meniere's disease.
• Subject agrees to maintain their current standard of care treatments for Meniere's disease while on-study.

Exclusion Criteria includes, but is not limited to:

• Subject has an infection in the ear, sinuses, or upper respiratory system.
• Subject is pregnant or lactating.
• Subject has a history of immunodeficiency disease.
• Subject has active or recent (<1 month prior to screening) middle ear disease, including but not limited to: chronic otitis media, acute otitis media, middle ear effusions, middle ear atelectasis, or cholesteatoma.
• Subject has experienced an adverse reaction to intratympanic injection of steroids.