Aerie Pharmaceuticals (NSDQ:AERI) touted 12-month safety data yesterday from the Phase III registration trial of its Roclatan eye drops for intraocular pressure resulting from glaucoma or ocular hypertension.
The study was designed to support Aerie’s new drug application submission to the FDA for Roclatan, which it expects to file in the first half of next year.
Safety data for the 12-month study period were consistent with results observed during the 90-day efficacy period in the Mercury 1 trial. Aerie reported that there were no new adverse events that developed following the initial 90-day period.
The most common adverse event was eye redness, which was reported in 60% of patients.
Intraocular pressure was also measured throughout the 12-month study period, Aerie said, and Roclatan lowered IOP better than latanoprost and Aerie’s Rhopressa – consistent with results observed in the initial 90-day study period.
“With these positive 12-month Mercury 1 data, we have again demonstrated the consistent and well-understood performance of Roclatan and Rhopressa from both a safety and efficacy perspective. Roclatan™ has the potential to become the most efficacious IOP-lowering therapy to enter the market, if approved, bolstered by an overall favorable safety and tolerability profile. We continue to expect to submit our Roclatan NDA in the first half of 2018,” chairman & CEO Vicente Anido, Jr., said in prepared remarks.
“This data readout represents the last in our series of Phase III trials for both Roclatan and Rhopressa for approval in the U.S., and we are now actively engaged in preparations for the expected Rhopressa commercialization next year.”
“As a clinician, I am very excited about the responder analysis data for Roclatan showing such a profound drop in IOP,” chief medical officer Dr. Richard Lewis added. “We now have a robust understanding of the Roclatan safety profile and expect that clinicians will be highly satisfied with the 12-month safety and efficacy data.”