The FDA unveils a new regulatory framework to speed along gene therapies, rewarding the leading players – Endpoints News

Posted: January 30, 2020 at 2:47 pm

What happens when a successful biotech venture capitalist is unexpectedly diagnosed with a chronic, life-disrupting vertigo disorder? Innovation in neurotology.

That venture capitalist was Jay Lichter, Ph.D., and after learning there was no FDA-approved drug treatment for his condition, Mnires disease, he decided to create a company to bring drug development to neurotology. Otonomy was founded in 2008 and is dedicated to finding new drug treatments for the hugely underserved community living with balance and hearing disorders. Helping patients like Jay has been the driving force behind Otonomy, a company heading into a transformative 2020 with three clinical trial readouts: Phase 3 in Mnires disease, Phase 2 in tinnitus, and Phase 1/2 in hearing loss. These catalysts, together with others in the field, highlight the emerging opportunity in neurotology.Otonomy is leading the way in neurotologyNeurotology, or the treatment of inner ear neurological disorders, is a large and untapped market for drug developers: one in eight individuals in the U.S. have moderate-to-severe hearing loss, tinnitus or vertigo disorders such as Mnires disease.1 With no FDA-approved drug treatments available for these conditions, the burden on patientsincluding social anxiety, lower quality of life, reduced work productivity, and higher rates of depressioncan be significant.2, 3, 4

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The FDA unveils a new regulatory framework to speed along gene therapies, rewarding the leading players - Endpoints News

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