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Otonomy’s OTIVIDEX ear medicine falls short in Phase III study

Published on 23/02/21 at 12:26pm

Otonomy’s OTIVIDEX treatment for Meniere’s disease has failed to meet its primary endpoint in its Phase III trial, the company announced this week.

Meniere’s disease is an ear condition which can cause vertigo, a symptom the treatment was intended to prevent. However, the count of definitive vertigo days in month three of treatment, versus the placebo, did not achieve statistical significance for the per protocol population.

The results were found after a four-month, randomised, double-blind trial of 149 patients in the US and Europe. Participants were randomised 1:1 to a single intratympanic injection of OTIVIDEX or placebo and then followed for three months.

It was reported earlier this week that Otonomy’s shares had fallen by 50.1% at news of the unsuccessful Phase III trial.

The company will now direct its research towards tinnitus and hearing loss, after studies showed successful results for their OTO-313 and OTO-413 treatments.

David A Weber, PhD, President and CEO of Otonomy, said: “We are disappointed by the top-line results for the primary intent-to-treat population and are undertaking an assessment to understand the difference observed with the per protocol analysis. We thank the many patients, clinical investigators and study site staff who supported this effort.” 

“Our focus turns to the strong pipeline we have built as recently highlighted by the successful clinical trial results for OTO-313 in tinnitus and OTO-413 in hearing loss. OTO-313 and OTO-413 each address a large patient population with significant unmet need and no approved drug therapy. These programmes provide an attractive opportunity for the company with clinical readouts anticipated in mid-2022.”

Jack Goddard

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