Hopes that a second clinical win for Otonomy Inc.'s phase III Meniere's disease candidate, Otividex, might set the stage for a third-quarter registration of the drug in the U.S. have been dashed, sending company shares (NASDAQ:OTIC) down 44.3% to $3 on Feb. 22. For the intent-to-treat (ITT) population, the trial missed its primary endpoint, the count of definitive vertigo days in month three for the sustained-exposure dexamethasone therapy vs. placebo. The trial also failed to achieve statistical significance for a per-protocol analysis. It was déjà vu for the company, which suffered a harsh reaction to an earlier setback for the program from which its stock has yet to recover, years later.
LONDON – After a number of equivocal small studies, the U.K. Recovery trial has applied its heft to turn in statistically significant evidence that the rheumatoid arthritis treatment Roactemra (tocilizumab) reduces mortality in hospitalized COVID-19 patients.
LONDON – New evidence from seven randomized controlled trials and a simultaneously conducted meta-analysis has again demonstrated that corticosteroids show significant benefit in patients who are critically ill with COVID-19, reducing length of hospital stay and cutting 28-day mortality.
LONDON – In the first major breakthrough in therapeutics for COVID-19 infection, dexamethasone has been shown to have a statistically significant impact on mortality in the most seriously ill patients.
LONDON – Oculis SA has delivered positive phase IIb data for OCS-01, a topical nanoparticle formulation of dexamethasone, in the treatment of the after-effects of cataract surgery, meeting the primary endpoints of reducing both inflammation and pain.
LONDON – Oculis SA reported positive results for its topical nanoparticle formulation of dexamethasone in the treatment of diabetic macular edema (DME), showing the eye drops reduced central macular thickness (CMT) in the phase II proof-of-concept trial.