Otonomy Reports Positive Top-Line Results from Phase 1/2 Clinical Trial of OTO-413
SAN DIEGO, CALIFORNIA — Otonomy, Inc. (Nasdaq: OTIC), a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology, today announced positive top-line results from the Phase 1/2 clinical trial of OTO-413 in subjects with speech-in-noise hearing difficulty. The randomized, double-blind, placebo-controlled trial demonstrated that a single intratympanic injection of OTO-413, a sustained exposure…
Read More
Otonomy Announces Exclusive License Agreement with Kyorin for Novel Compound in Hair Cell Regeneration Program
SAN DIEGO, CALIFORNIA — Otonomy, Inc., a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology, has announced an exclusive license agreement with Kyorin Pharmaceutical Co., Ltd. that provides Otonomy with exclusive worldwide rights to develop, manufacture and commercialize a novel compound for the treatment of sensorineural hearing loss. Under the terms of…
Read More
Otonomy Reports Positive Top-Line Results from Phase 1/2 Clinical Trial of OTO-313 for Tinnitus
SAN DIEGO, CALIFORNIA — Otonomy, Inc., a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology, announced positive top-line results from the Phase 1/2 clinical trial of OTO-313 in patients with persistent tinnitus of at least moderate severity. The exploratory efficacy cohort of the trial included 31 evaluable patients randomized to a single…
Read More
Otonomy and AGTC Present Preclinical Results for GJB2 Gene Therapy Hearing Loss Program
SAN DIEGO, CALIFORNIA — Otonomy, Inc., a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology, today announced preclinical results from the company’s gene therapy collaboration with Applied Genetic Technologies Corporation (AGTC) that support the selection of a product candidate for development as a treatment for gap junction beta-2 (GJB2) deficiency, the most…
Read MoreOtonomy Initiates Phase 1/2 Clinical Trial of OTO-313 for Tinnitus
SAN DIEGO, CALIFORNIA — Otonomy has announced the initiation of a Phase 1/2 clinical trial of OTO-313 in patients with tinnitus. The randomized, double-blind, placebo-controlled Phase 1/2 study will include an initial safety cohort followed by an exploratory efficacy study that will enroll approximately 50 patients with subjective tinnitus. OTO-313 is said to be a…
Read More
After Disappointing Results on Phase 3 Trial of Meniere’s Drug, Otonomy Lays off Staff, Suspends Further Trials in 2017
SAN DIEGO, CALIFORNIA — Following disappointing AVERTS-1 Phase 3 trial results of OTIVIDEX in Ménière’s disease patients, Otonomy, Inc., a US-based biopharmaceutical firm, announced that the company is laying off one-third of its noncommercial staff and will not initiate any further clinical trials through the end of 2017. With the announcement, the timing for initiation…
Read More
Otonomy Enrolling Patients in Phase 2 Clinical Trial of OTO-104, to Prevent Cisplatin-Induced Hearing Loss
SAN DIEGO, CALIFORNIA — Otonomy, Inc., a US-based biopharmaceutical firm, announced the enrollment of its first patients in a Phase 2 clinical trial evaluating OTO-104 for prevention of hearing loss in cancer patients undergoing chemotherapy with platinum-based agents, such as cisplatin. This multicenter trial is designed to evaluate the feasibility, safety and efficacy of OTO-104,…
Read More
FDA Fast Tracks Tinnitus Drug; Meniere’s Drug Completes Year-Long Safety Trial
ZUG, SWITZERLAND — Biopharmaceutical company Auris Medical Holdings announced late last month that the US Food and Drug Administration (FDA) granted Fast Track designation to its investigational drug, KeyzilenTM (AM-101). Keyzilen is esketamine gel for intratympanic injection, intended for acute peripheral tinnitus following cochlear injury or otitis media in adults. The Fast Track designation by the FDA of an…
Read More