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Otividex
- Development stage
- Phase 3
- Lead developer
- Otonomy
- Modality
- Small Molecules, Nanoparticles → Drug Delivery Systems
- Administration
- Intratympanic
01
Overview
Otividex is an intratympanic, sustained-exposure formulation of the corticosteroid dexamethasone, based on a thermosensitive poloxamer hydrogel (originally OTO-104) designed to provide prolonged drug release into the inner ear following a single middle-ear injection. It was developed by Otonomy for the treatment of unilateral Ménière’s disease and for prevention of cisplatin-induced hearing loss, aiming to deliver high local steroid concentrations to vestibular and cochlear structures while minimizing systemic exposure. Prolonged dexamethasone exposure is intended to exert anti-inflammatory and immunosuppressive effects in the inner ear, modulating endolymphatic hydrops and vestibular symptoms such as vertigo; however, multiple Phase 3 trials in Ménière’s disease failed to meet primary vertigo endpoints, leading to cessation of development and subsequent transfer of OTO-104/Otividex assets to Spiral Therapeutics.[1][3][4][7]
- Brand names
- Otividex
- Other names
- OTIVIDEX
02
Targets
GR (Glucocorticoid receptor)
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