Aerie Pharma rockets on helpful Rhopressa communication from FDA

US clinical-stage ophthalmics firm Aerie Pharmaceuticals (Nasdaq: AERI) saw its shares leap 40.9% to $18.70 in after-hours trading yesterday on positive regulatory news relating to its 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.

The US Food and Drug Administration has agreed in written and verbal communications that Aerie may change the primary endpoint range of its second Phase III registration trial of Rhopressa, named Rocket 2. With this agreement, the company is changing the primary endpoint range to include patients with baseline intraocular pressures (IOPs) ranging from above 20mmHg (millimeters of mercury) to below 25mmHg. The former range for the primary endpoint of above 20mmHg to below 27mmHg will now represent a secondary endpoint range for Rocket 2.

Just a few weeks ago, Aerie saw its shares plunge more than 70% to $10.60 after it reported that the Rocket 1 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 (The Pharma Letter April 27).