Otonomy has presented preclinical results for OTO-104, a sustained release dexamethasone gel for the treatment of hearing and balance disorders. The studies demonstrate that OTO-104, which was well tolerated, can effectively deliver a prolonged and dose-proportional exposure of dexamethasone to the inner ear when administered by direct injection. The data was presented at the 2010 Combined Otolaryngology Spring Meeting in Las Vegas.
In guinea pigs and sheep, therapeutic levels of dexamethasone could be sustained for more than four weeks at the highest single dose. The studies also provided the first demonstration of dose proportionality, whereby inner ear concentrations of dexamethasone are related to the dose of OTO-104 administered.
Otonomy has initiated a prospective, randomized, placebo-controlled, multicenter, Phase Ib study of OTO-104 given as a single injection in subjects with unilateral Ménière's disease. While the primary endpoint of the study is safety and tolerability, a number of efficacy endpoints will be monitored, including the frequency of vertigo attacks experienced by patients pre- and post-treatment.
- here's the Otonomy release