Aerie Pharmaceuticals announced that the second Phase 3 trial, Rocket 2, for Rhopressa achieved its primary efficacy endpoint demonstrating non-inferiority compared to timolol for the treatment of increased intraocular pressure (IOP) in patients with glaucoma or ocular hypertension.
Rocket 2 is a 12-month safety trial with a 90-day interim efficacy readout. The primary efficacy endpoint evaluated subjects with pre-study baseline IOPs of above 20 to below 25mmHg. The efficacy results for Rhopressa demonstrated a consistent level of IOP lowering across all baseline IOPs and throughout the 90-day efficacy period.
Based on the positive results of Rocket 2, Aerie expects to submit a New Drug Application (NDA) filing for Rhopressa in mid-2016.
Rhopressa is a once-daily eye drop that exhibits its triple action by specifically targeting the eye’s trabecular meshwork, lowering episcleral venous pressure, and reducing fluid production in the eye, therefore lowering IOP.
For more information visit AeriePharma.com.