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            Lead Product(s): Dexamethasone

            Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Product Name: Otividex

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable May 14, 2021

            Details:

            Results demonstrate that a single administration of OTO-825 rescues hearing loss and cochlear damage in two preclinical models that represent a range of hearing loss severity caused by GJB2 deficiency.

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            Lead Product(s): Dexamethasone

            Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Product Name: Otividex

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable February 22, 2021

            Details:

            The Phase 3 clinical trial of OTIVIDEX in patients with Ménière’s disease did not achieve the primary endpoint, which was the count of definitive vertigo days in Month 3 for OTIVIDEX vs. placebo for the intent-to-treat population using the Negative Binomial Model.

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            Lead Product(s): Dexamethasone

            Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Product Name: Otividex

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable November 30, 2020

            Details:

            FDA’s review of the OTIVIDEX statistical analysis plan confirms use of the Negative Binomial model for analysis of the primary endpoint in the ongoing Phase 3 clinical trial in Ménière’s disease.

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            Lead Product(s): Benralizumab,Mometasone Furoate

            Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Product Name: Fasenra

            Highest Development Status: Phase III Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable September 10, 2020

            Details:

            Fasenra showed a statistically significant improvement in the endoscopic total nasal polyp score and the nasal blockage score compared to placebo, in patients with severe bilateral nasal polyposis who were still symptomatic despite continued treatment with standard of care.