Aerie Pharma's eye drug Rhopressa fails primary endpoint

US clinical stage company Aerie Pharmaceuticals (Nasdaq: AERI) has reported disappointing results of its first Phase III registration trial (Rocket 1) for Rhopressa, previously known as AMA0076, a novel once-daily, triple-action eye drop being tested for its ability to lower intraocular pressure (IOP) in patients with glaucoma or ocular hypertension. Aerie’s shares plunged more than 70% to $10.60 following the news last week.

The trial did not meet its primary efficacy endpoint of demonstrating non-inferiority of IOP lowering for once-daily Rhopressa compared to twice-daily timolol, the most widely used comparator in registration trials for glaucoma.

However, Rhopressa demonstrated non-inferiority compared to timolol for patients in the study with IOP below 26 millimeters of mercury (mmHg) at all nine measured time points and numerical superiority over timolol at the majority of measured time points. Around 80% of glaucoma patients have IOP of 26mmHg or less at the time of diagnosis.