Friday, October 28, 2016
Aerie Pharmaceuticals reports positive topline efficacy results of ROCKET 4 phase 3 trial of Rhopressatm (netarsudil ophthalmic solution) 0.02 percent.
Aerie Pharmaceuticals Inc - Study successfully achieves primary efficacy endpoint.
Aerie Pharmaceuticals Inc - Company separately announces withdrawal of Rhopressa ( TM ) NDA, with expectation of refiling in January 2017.
Aerie - Rhopressa NDA withdrawn as result of a third party manufacturing facility in Tampa, Florida not being ready for pre-approval inspection by FDA.
Aerie Pharmaceuticals Inc - Drug product contract manufacturer has advised Aerie and FDA that it expects to be prepared for FDA inspection in January 2017.
Source : reuters.com
