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OTO-413 is a proprietary, sustained-exposure formulation of brain-derived neurotrophic factor (BDNF), a naturally occurring protein involved in neuron growth and repair. It is designed for local administration to the inner ear via intratympanic injection. The drug aims to repair synaptic connections between inner hair cells and auditory nerve fibers in the cochlea that are damaged due to noise trauma or ototoxic chemicals. Preclinical studies have shown that BDNF can restore these connections, which is associated with improved hearing function. Clinical trials have demonstrated that OTO-413 is well-tolerated and may improve speech-in-noise hearing performance in patients with sensorineural hearing loss.
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