Hearing Loss Treatment Report

www.HearingLossTreatmentReport.com

OTO-413

OTO-413 Phase 1/2 trial expansion in hearing loss expected to start in Q2 2021 with results anticipated in mid-2022

https://www.globenewswire.com/news-release/2021/02/11/2174562/0/en/Otonomy-Reports-Fourth-Quarter-and-Full-Year-2020-Financial-Results-and-Provides-Corporate-Update.html

Otonomy Reports Fourth Quarter and Full Year 2020 Financial Results and Provides Corporate Update

February 11, 2021 16:17 ET | Source: Otonomy, Inc.
OTIVIDEX® Phase 3 trial results in Ménière’s disease expected by end of February
OTO-313 Phase 2 trial in tinnitus planned to start in first quarter of 2021 with top-line results expected in mid-2022
OTO-413 Phase 1/2 trial expansion in hearing loss expected to start in second quarter of 2021 with results anticipated in mid-2022

Otonomy Reports Positive Top-Line Results from Phase 1/2 Clinical Trial of OTO-413 in Patients with Hearing Loss

https://investors.otonomy.com/news-releases/news-release-details/otonomy-reports-positive-top-line-results-phase-12-clinical-0

Otonomy Reports Positive Top-Line Results from Phase 1/2 Clinical Trial of OTO-413 in Patients with Hearing Loss
December 17, 2020 at 7:00 AM EST
OTO-413 demonstrated a higher proportion of responders than placebo based on multiple speech-in-noise hearing tests

OTO-413 in Subjects With Speech-in-Noise Hearing Impairment

https://clinicaltrials.gov/ct2/show/NCT04129775?type=Intr&cond=Hearing+Loss&lupd_s=10%2F03%2F2019&lupd_d=14&sort=nwst

Condition :   Sensorineural Hearing Loss

Interventions :   Drug: OTO-413;   Drug: Placebo

Sponsor :   Otonomy, Inc.

Recruiting

OTO-413 in Subjects With Speech-in-Noise Hearing Impairment

NCT04129775

Thu, 17 Oct 2019 12:00:00 EDT

Last Update Posted: 10/17/19 08:21AM

https://clinicaltrials.gov/ct2/show/NCT04129775

OTO-413 in Subjects With Speech-in-Noise Hearing Impairment

Updated: September 14, 2020
Active, not recruiting

Study Type : Interventional (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled Phase 1/2 Study of OTO-413 Given as a Single Intratympanic Injection in Subjects With Speech-in-noise Hearing Impairment
Actual Study Start Date : October 1, 2019
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : October 2020

Otonomy Provides Update on OTO-413 Clinical Trial: Results from Phase 1/2 study of OTO-413 for hearing loss expected in fourth quarter of 2020

https://www.globenewswire.com/news-release/2020/06/15/2048357/0/en/Otonomy-Provides-Update-on-Clinical-Trials-and-Development-Programs.html

Otonomy Provides Update on Clinical Trials and Development Programs

June 15, 2020 16:05 ET | Source: Otonomy, Inc.

  • Results from Phase 3 trial of OTIVIDEX® in Ménière’s disease expected in first quarter of 2021
  • Results from Phase 1/2 trial of OTO-313 in tinnitus expected in July 2020
  • Results from Phase 1/2 trial of OTO-413 in hearing loss expected in fourth quarter of 2020

SAN DIEGO, June 15, 2020 (GLOBE NEWSWIRE) — Otonomy, Inc. (Nasdaq: OTIC), a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology, today provided an update on its product pipeline and the timeline to results for the company’s three ongoing clinical trials, including the Phase 3 trial of OTIVIDEX in Ménière’s disease. The company will host a conference call and webcast today at 4:30 p.m. ET to review these updates.

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