Otonomy Announces FDA Acceptance of AuriPro(TM) New Drug Application

SAN DIEGO, April 28, 2015 (GLOBE NEWSWIRE) Otonomy, Inc. (Nasdaq:OTIC), a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapeutics for diseases and disorders of the inner and middle ear, today announced that its New Drug Application (NDA) for the approval of AuriProTM as a treatment of middle ear effusion in pediatric patients undergoing tympanostomy tube placement (TTP) surgery has been accepted for filing by the U.S. Food and Drug Administration (FDA). The acceptance of the NDA indicates the application is sufficiently complete to permit a substantive review by the FDA.

Read More

Otonomy to Present AuriPro(TM) Phase 3 Results at American Society of Pediatric Otolaryngology Conference

SAN DIEGO, April 21, 2015 (GLOBE NEWSWIRE)Otonomy, Inc. (Nasdaq:OTIC), a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapeutics for diseases and disorders of the inner and middle ear, today announced that previously reported results from two Phase 3 trials evaluating AuriPro™ in pediatric patients with middle ear effusion undergoing tympanostomy tube placement surgery will be presented in a podium presentation at the 2015 American Society of Pediatric Otolaryngology (ASPO) meeting, held during the Combined Otolaryngology Spring Meetings in Boston on April 22-26, 2015.

Read More

Otonomy Completes Enrollment of OTO-104 Multiple-Dose Safety Study in Meniere’s Disease Patients

SAN DIEGO, April 20, 2015 (GLOBE NEWSWIRE)Otonomy, Inc. (Nasdaq:OTIC), a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapeutics for diseases and disorders of the inner and middle ear, today announced that it has achieved target enrollment in its multiple-dose safety study of OTO-104 in patients with Ménière’s disease.

Read More

Otonomy Initiates Phase 2 Clinical Trial for AuriPro(TM) in Label Expansion Indication

AuriPro to be Evaluated in Pediatric Patients With Acute Otitis Media With Tympanostomy Tubes

SAN DIEGO, March 26, 2015 (GLOBE NEWSWIRE)Otonomy, Inc. (Nasdaq:OTIC), a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapeutics for diseases and disorders of the inner and middle ear, today announced the enrollment of the first patients in a Phase 2 clinical trial evaluating AuriProTM for the treatment of pediatric patients with acute otitis media with tympanostomy tubes (AOMT).

Read More