Shares Of Aerie Pharmaceuticals Drop 70% In After Hours After Reporting Disappointing Phase 3 Results
Shares of Aerie Pharmaceuticals (AERI) are down 70% in after hours trade after the company reported that the Rocket 1 phase 3 trial failed to meet the primary endpoint in the study. Rhopressa is a novel once-daily, triple action eye drop being tested for the ability to lower intraocular pressure in patients with glaucoma or ocular hypertension.
The trial known as Rocket 1 recruited 370 patients who either took a once-daily drop of Rhopressa or a twice daily timilol -- which is a standard of care beta-blocker drug for glaucoma patients. The primary endpoint of the study was for Rhopressa to show non-inferiority of intraocular pressure as compared to timilol. Although Rhorpessa failed to do this and thus the Rocket 1 trial concludes with a failing of the primary endpoint.
In addition to missing the primary endpoint in this trial, 36 patients out of the 182 patients in the Rhopressa arm saw a 20% decline in efficacy during the study. There is another study known as the Rocket 2 study which is the company's 2nd phase 3 trial which is also assessing Rhopressa for intraocular pressure. Aerie will now await the results from this trial which is expected to be released in Q3 2015. From there the company will determine the future of the Rhopressa drug, and determine if it needs to run a new phase 3 trial to achieve better efficacy results.
Disclosure: no position any stocks mentioned
and? what's your take mr biotech? surely you have one..
my take is that the fact that Aerie will probably have to run another phase 3 trial and work the FDA on a new trial design
Thank you, Terry.