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Our pipeline

We are passionate about coupling our deep understanding of the neuroscience of the ear with our drug delivery and development expertise to advance a broad product pipeline to address significant unmet needs in neurotology.

Program
(Target Indication)
Compound
Status
OTIVIDEX™
(Ménière's disease)
dexamethasone
Phase 3

OTIVIDEX is a sustained-exposure formulation of the steroid dexamethasone for patients with Ménière’s disease that has completed one successful Phase 3 clinical trial. An additional Phase 3 trial to support a submission for registration is ongoing with results expected in the first half of 2020.

OTO-313
(tinnitus)
gacyclidine
Phase 1/2

OTO-313 is a sustained-exposure formulation of gacyclidine, a potent and selective NMDA receptor antagonist, in development for the treatment of tinnitus. A Phase 1/2 trial, evaluating safety and exploratory efficacy measures of OTO-313 is underway, with results expected in the first half of 2020.

OTO-413
(hearing loss)
BDNF
Phase 1/2

OTO-413 is a sustained-exposure formulation of brain-derived neurotrophic factor (BDNF) which is a naturally occurring protein involved in neuron growth and repair. Nonclinical studies have demonstrated that local administration of BDNF repairs neuronal synapses damaged due to noise trauma or exposure to ototoxic chemicals and restores hearing function. A Phase 1/2 clinical trial for OTO-413 in patients with speech-in-noise-hearing difficulty is underway with results expected in the second half of 2020.

OTO-510
(CIHL)
Undisclosed
Pre-Clinical

OTO-510 is a sustained-exposure formulation of an undisclosed small molecule designed for intratympanic administration to provide protection against cisplatin-induced hearing loss (CIHL), without tumor protection.

OTO-6XX
(hair cell regeneration)
Undisclosed
Pre-Clinical

OTO-6XX induces hair cell regeneration and is being developed for the treatment of severe hearing loss. Otonomy has selected a lead compound for development.

Gene Therapy Program
(congenital hearing loss)
GJB2 gene
Pre-Clinical

Otonomy has established a strategic corporate collaboration to develop a gene therapy treatment targeting mutations in the gap junction protein beta 2 gene (GJB2) - the most common cause of congenital hearing loss.