FDA gives Auris Medical Holding AG (NASDAQ:EARS) Treatment Guidance On Hearing Defect


Auris Medical Holding AG (NASDAQ:EARS) is a biopharmaceutical provider that focuses in coming up with top-notch therapeutics. It specifically focuses in mental disorders supportive care and neurotology. It was today that the business guru provided updates in line with the Type C meeting conducted earlier.

A close outlook

It was a meeting between the company and the U.S. Food and Drug Administration (FDA).The agenda was the regulatory pathway and development plan for the AM-111 which is the company’s investigational product. The company hopes the product will help it treat the sudden sensorineural hearing defect.

It was a short while ago that the company received results of the HEALOS phase 3 trial. Later on, it requested for the Type C meeting. The post-hoc analysis helped provide easy to follow results that were clinically meaningful.

They indicated that the AM-111 0.4 mg/mL group was by far well off as compared to the placebo group of patients. This was a group struggling with profound hearing loss. The first group experienced significant improvement in hearing.

It was a research initially involving completely deaf or almost deaf patients on the affected ear. One of the researches said that quite a significant number of patients around the globe received poor prognosis for hearing recovery.

The turn of events

The regulatory body has been quite busy lately. It spent quite a great deal of time looking into the concept of a placebo-controlled pivotal trial proposed by the business. The area of focus has been the patients experiencing acute profound hearing loss. These patients took AM-111 0.4 mg/mL.

Auris Medical’s founder Thomas Meyer has applauded the FDA for the feedback as well as for the guidance it gave in line with the AM-111 program.

Meyer opined, “We are very pleased to be aligned with the FDA and EMA on key design aspects for the planned phase 3 trial and look forward to working with the agencies as we continue to develop AM-111 as a potential first-in-class treatment for sudden sensorineural hearing loss.”

Reports also indicate that the company is currently 48% up ahead of the latest equity offering.

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