Aerie Pharmaceuticals reported that it has received notification from the FDA that the agency has completed its initial 60-day review of the Rhopressa new drug application (NDA) and determined that the application is sufficiently complete to permit a substantive review. The PDUFA (Prescription Drug User Fee Act) goal date for the completion of the FDA’s review of the Rhopressa NDA is set for February 28, 2018. This date reflects a standard 12-month review period and is consistent with management’s expectations. The notification also indicated that the FDA has not identified any potential review issues, and that the FDA is currently planning to hold an advisory committee.
“We are obviously delighted with this positive news on our Rhopressa NDA. The February 28, 2018 PDUFA date and the advisory committee plans are consistent with our previously disclosed expectations. Further, we very much look forward to the upcoming Mercury 2 Phase 3 readout for Roclatan, which remains on track for this quarter,” Vicente Anido, Jr., PhD, Chairman and Chief Executive Officer at Aerie, said in a company news release.
Rhopressa (netarsudil ophthalmic solution) 0.02%, is a novel eye drop that, if approved, would become the only once-daily product available that, based on Aerie’s preclinical and clinical studies, specifically targets the trabecular meshwork, the eye’s primary fluid drain and the diseased tissue responsible for elevated IOP in glaucoma. Preclinical and clinical studies have also demonstrated that Rhopressa lowers episcleral venous pressure, which contributes approximately half of IOP in healthy subjects. Further, based on Aerie’s preclinical studies, Rhopressa may provide an additional mechanism that reduces fluid production in the eye and therefore lowers IOP. Biochemically, the active ingredient in Rhopressa, netarsudil, has been shown in Aerie studies to inhibit both Rho Kinase (ROCK) and norepinephrine transporter (NET). Recent preclinical studies have also shown that Rhopressa may have disease-modifying properties, including an anti-fibrotic effect of netarsudil on trabecular meshwork cells and the potential to increase perfusion of the trabecular meshwork.
The results of two phase 3 registration trials (Rocket 2 and Rocket 1) for Rhopressa were included in the NDA submission to the FDA in February 2017. There were two additional phase 3 registration trials for Rhopressa, named Rocket 3 and Rocket 4. Rocket 3 was a small 12-month safety-only study in Canada that was not necessary for the NDA submission and for which we have discontinued enrollment. Rocket 4, which was completed in April 2017, was designed to provide adequate 6-month safety data for regulatory filing purposes in Europe, and was also not necessary for the NDA submission. The 90-day efficacy results from Rocket 4 and Mercury 1, the initial phase 3 registration trial for Aerie product candidate Roclatan (netarsudil/latanoprost ophthalmic solution) 0.02%/0.005%, were also included in the Rhopressa NDA submission as supportive. The FDA has set the PDUFA goal date for the completion of the FDA’s review of the Rhopressa NDA for February 28, 2018.