Phase 3 Study of OTO-104 in Subjects With Unilateral Meniere's Disease

Inclusion Criteria:

- Subject has a diagnosis of unilateral Meniere's disease by 1995 American Academy of
Otolaryngology - Head and Neck Surgery (AAOHNS) criteria and reports active vertigo
for the 2 months prior to the study lead-in period.

- Subject has experienced active vertigo during the lead-in period.

- Subject has documented asymmetric sensorineural hearing loss.

- Subject agrees to maintain their current treatments for Meniere's disease while
on-study.

Exclusion Criteria:

- Subject is pregnant or lactating.

- Subject has a history of immunodeficiency disease.

- Subject has a history of significant middle ear or inner ear surgery, or endolymphatic
sac surgery in the affected ear.

- Subject has a history of tympanostomy tubes with evidence of perforation or lack of
closure.

- Subject has a history of vestibular migraine.

- Subject has used an investigational drug or device in the 3 months prior to screening.

- Subject has previously been randomized to a clinical study of OTO-104.