SAN DIEGO, CA, USA I July 26, 2018 I Otonomy, Inc. (NASDAQ:OTIC), a biopharmaceutical company dedicated to the development of innovative therapeutics for otology, today announced initiation of the additional Phase 3 trial required to support a submission for U.S. registration of OTIVIDEX in Ménière’s disease. The company expects to have top-line results from this trial in the first half of 2020.
“We are excited to initiate this trial for OTIVIDEX, which we believe is the remaining clinical requirement to bring a new treatment option to Ménière’s disease patients experiencing debilitating vertigo episodes,” said David A. Weber, Ph.D., president and CEO of Otonomy. “This announcement demonstrates our commitment to achieving our milestones and reinforces our leadership position in the emerging otology field.”
The design and conduct of this pivotal trial is based on the successful AVERTS-2 Phase 3 trial. This trial retains the same primary efficacy endpoint, daily diary vertigo scale, use of a one-month lead-in period, and primary analysis at three months after a single treatment. The company plans to enroll approximately 160 patients, with the majority expected to be recruited in Europe where the AVERTS-2 trial was conducted. Additional steps have been taken to manage patient expectation bias and the placebo response including refinement of site selection criteria, emphasizing recruitment of well-characterized Ménière’s patients known to the investigators, and careful management of clinical site communication with study subjects.
About Otonomy
Otonomy is a biopharmaceutical company dedicated to the development of innovative therapeutics for otology. The company pioneered the application of drug delivery technology to the ear in order to develop products that achieve sustained drug exposure from a single local administration. This approach is covered by a broad patent estate and is being utilized to develop a pipeline of products addressing important unmet medical needs including Ménière’s disease, hearing loss, and tinnitus. For additional information please visit www.otonomy.com.
SOURCE: Otonomy
Post Views: 19
SAN DIEGO, CA, USA I July 26, 2018 I Otonomy, Inc. (NASDAQ:OTIC), a biopharmaceutical company dedicated to the development of innovative therapeutics for otology, today announced initiation of the additional Phase 3 trial required to support a submission for U.S. registration of OTIVIDEX in Ménière’s disease. The company expects to have top-line results from this trial in the first half of 2020.
“We are excited to initiate this trial for OTIVIDEX, which we believe is the remaining clinical requirement to bring a new treatment option to Ménière’s disease patients experiencing debilitating vertigo episodes,” said David A. Weber, Ph.D., president and CEO of Otonomy. “This announcement demonstrates our commitment to achieving our milestones and reinforces our leadership position in the emerging otology field.”
The design and conduct of this pivotal trial is based on the successful AVERTS-2 Phase 3 trial. This trial retains the same primary efficacy endpoint, daily diary vertigo scale, use of a one-month lead-in period, and primary analysis at three months after a single treatment. The company plans to enroll approximately 160 patients, with the majority expected to be recruited in Europe where the AVERTS-2 trial was conducted. Additional steps have been taken to manage patient expectation bias and the placebo response including refinement of site selection criteria, emphasizing recruitment of well-characterized Ménière’s patients known to the investigators, and careful management of clinical site communication with study subjects.
About Otonomy
Otonomy is a biopharmaceutical company dedicated to the development of innovative therapeutics for otology. The company pioneered the application of drug delivery technology to the ear in order to develop products that achieve sustained drug exposure from a single local administration. This approach is covered by a broad patent estate and is being utilized to develop a pipeline of products addressing important unmet medical needs including Ménière’s disease, hearing loss, and tinnitus. For additional information please visit www.otonomy.com.
SOURCE: Otonomy
Post Views: 19
