Otonomy Inc (NASDAQ:OTIC) has announced the grand plans to focus its resources on the development of various clinical and preclinical programs that can address the unmet medical needs in the field of Otology. The company is particularly planning to complete the clinical development to support the approval of OTIVIDEX™ in the US for treatment of patients suffering from the Ménière’s disease and expanding multiple other programs that address the hearing loss and tinnitus conditions.
The company also plans to discontinue the commercial support of the OTIPRIO® program which will significantly reduce the company’s future operating expenses. According to the company, divesting the OTIPRIO program will terminate the one-third of the workforce that have directly been involved in the program which will bring a cash savings of over $20 million starting next year.
Otonomy is currently committed to developing the treatment for the chronic Ménière’s condition for patients who are in dire need of the treatment. The company has a new strategy to refocus all its pipeline developmental programs to attain the goal of making available the Otividex for Ménière’s disease.
During the last quarterly report, the company stated that the customer’s demand for Otiprio reduced by 9% compared with the outcomes from the second quarterly of the year. The US Food and Drug Administration (FDA) is currently reviewing supplement New Drug Application for the Otiprio for treatment of acute otitis externa. The FDA final decision on the treatment will be disclosed in March 2018.
In August, Otonomy announced that the US arm managing its Phase III study of the Otividex declined and failed to meet the required endpoints for the development of the program. More than one-third of the Otonomy workforce is likely to lose their jobs in the process. The company has however stated that its European Phase III study for Otividex has demonstrated the clinically significant benefits for patients suffering from the Ménière’s disease.