SAN DIEGO, May 04, 2017 (GLOBE NEWSWIRE) -- Otonomy, Inc. (NASDAQ:OTIC), a biopharmaceutical company focused on the development and commercialization of innovative therapeutics for diseases and disorders of the ear, today reported financial results for the quarter ended March 31, 2017 and provided an update on its corporate activities and product pipeline.
First Quarter 2017 and Subsequent Highlights
• Enrollment Completed in the U.S. Phase 3 AVERTS-1 Trial for OTIVIDEXä in Ménière’s Disease, with Results Expected in the Third Quarter of 2017: Otonomy is conducting two identical, parallel Phase 3 trials for OTIVIDEX (formerly known as OTO-104) in patients with Ménière’s disease, AVERTS-1 in the United States and AVERTS-2 in Europe. Each trial is a 16-week, prospective, randomized, double-blind, placebo-controlled trial designed to enroll approximately 160 patients with unilateral Ménière’s disease. A total of 165 patients were enrolled in the AVERTS-1 trial, and topline data is expected in the third quarter of 2017. Enrollment is ongoing in the AVERTS-2 trial with topline data expected by the end of 2017.
• OTIPRIO® Launch Update: OTIPRIO (ciprofloxacin otic suspension) is approved in the United States for the treatment of pediatric patients with bilateral otitis media with effusion undergoing tympanostomy tube placement (TTP). In March 2017, Otonomy announced a number of changes to its commercial organization to increase the focus on OTIPRIO utilization and improve sales performance. These changes include the hiring of David Kaplan, vice president of sales, who previously led the sales team at Pacira Pharmaceuticals, focusing and realigning the sales force to 20 sales territories to provide coverage of 400 priority accounts that collectively comprise about one-third of the U.S. TTP market, and replacing sales personnel where necessary to improve sales performance.
An update of key commercial metrics include:
-- End user demand totaled 1,334 vials during the first quarter of 2017 representing an increase of 14% from the fourth quarter of 2016.
-- From launch through the end of March, more than 220 facilities had purchased OTIPRIO with over 60% of these accounts placing repeat orders.
-- Ongoing tracking of reimbursement claims by Otonomy’s third party vendor continues to demonstrate separate payment for OTIPRIO in addition to the TTP procedure itself by multiple payors for both Medicaid and commercially-insured patients.
• Announced Positive Top-Line Results from Phase 3 Trial of OTIPRIO in Patients with Acute Otitis Externa (AOE) and submitted sNDA: In January 2017, Otonomy announced positive results from its pivotal Phase 3 clinical trial of OTIPRIO in 262 pediatric and adult patients with AOE, also known as swimmer’s ear. This single administration trial of OTIPRIO met its primary endpoint showing a statistically significant increase in clinical cure rate compared to sham (no treatment) at Day 8 (p<0.001). OTIPRIO also demonstrated a statistically significant superiority to sham in clinical cure rate at all other time points assessed including Day 4 (p=0.021), Day 15 (p<0.001) and Day 29 (p<0.001), and was well-tolerated. Based on these positive results, Otonomy recently submitted a Supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA).
• Initiated Patient Enrollment for Phase 2 Trial of OTIVIDEX in Hearing Loss Indication: In January 2017, Otonomy initiated enrollment of the first patients in a Phase 2 trial evaluating OTIVIDEX for the prevention of hearing loss in pediatric cancer patients undergoing chemotherapy with platinum-based agents. This multicenter trial is designed to assess the feasibility, safety and exploratory efficacy of OTIVIDEX given by intratympanic administration in subjects at risk for ototoxicity from cisplatin chemotherapy.
• Sucessfully Completed Phase 1 Clinical Safety Trial of OTO-311, a Potential Tinnitus Treatment: OTO-311 is a single-dose, sustained-exposure formulation of the potent and selective N-Methyl-D-Aspartate (NMDA) receptor antagonist gacyclidine that is in development for the treatment of tinnitus. OTO-311 was well-tolerated in the Phase 1 trial, and a dose was selected for evaluation in a Phase 2 clinical trial that is expected to start in the second half of 2017.
