Otonomy Otividex AVERTS-2 Results for Meniere's

Awhile back I posted about the results of Otonomy's AVERTS-1 trial for Meniere's Disease (https://www.tinnitustalk.com/threads/otonomy-otividex-fails-in-phase-3-ménières-trial.23648/). The top-line results of the second Phase 3 trial have been released and are positive. There appears to be a statistically significant reduction in "definitive vertigo days" compared to placebo. I'd like to see the full results because it appears that the sample size drops from baseline to month 3, and it would be interesting to know why. It isn't clear whether there is a similar drop in the AVERTS-1 data.

The top-line results for AVERTS-2 are here http://phx.corporate-ir.net/Externa...9NjgzOTM0fENoaWxkSUQ9MzkzNzcyfFR5cGU9MQ==&t=1
and the press release is here http://investors.otonomy.com/phoenix.zhtml?c=234082&p=irol-newsArticle_Print&ID=2315557.

The results have had a positive effect on Otonomy's stock price so it will see how this affects some of the decisions they made a couple of months ago.

 

That is just wonderful news for anybody with Ménière’s disease. Well done Otonomy!

 

From their financial report:

 

Wonderful! It's a good piece of news!

But that leads me to ask the question: what were the differences between the protocol of AVERTS-1 and the protocol of AVERTS-2 to obtain such different results? Does anybody know?

 

Does this mean there is another company on the run for hair cell regenaration?

 

@glynis - here's some hope!

 

Otonomy's fourth program OTO-4XX is said to focus on hearing loss including hair cell regeneration (http://www.otonomy.com/pipeline/oto-4xx/), but that is a long way off at this point.

 

Based on the first article, didn't they suspend their second study?

David A. Weber, Ph.D., president and CEO of Otonomy. 'Based on these results, we are immediately suspending all development activities for OTIVIDEX including the ongoing AVERTS-2 trial.'

 

Otividex is a steroid they say in the press release. Ok, but so is dexamethason which is nowadays used for Meniere's. What does it do (better)? And does it destroy hair cells further in order to retrieve less vertigo? Does it destroy the vestibular organ like gentamycine?

 

They don't know how steroids work.