Rhopressa (netarsudil ophthalmic solution 0.02%) demonstrated non-inferiority to twice-daily timolol in lowering IOP in patients with glaucoma or ocular hypertension, according to Aerie Pharmaceuticals.
Rhopressa inhibits both Rho kinase and norepinephrine transporter and relaxes the trabecular meshwork to increase outflow and lower episcleral venous pressure.
"We have accumulated a wealth of information on how Rhopressa performs, with nearly 2,000 patients dosed and approximately 150 investigator sites engaged in our Phase 3 clinical trials.” said Richard A. Lewis, MD, Aerie's chief medical officer. “It is very clear to me that, if approved, this novel IOP-lowering product that targets the diseased tissue has the potential to be a meaningful new therapy for patients with glaucoma or ocular hypertension."
The most common adverse event was hyperemia, reported in approximately 40% of patients, of which 85% were scored as mild. There were no drug-related systemic or serious adverse events.
The trial, Rocket 4, is designed to provide adequate six-month safety data for European regulatory filing purposes. Rocket 4 is not necessary for new drug application (NDA) filing purposes. It is expected to be completed by early 2017.
In addition, Aerie announced it has withdrawn the NDA for Rhopressa that was filed recently with the FDA. The filing was withdrawn as the result of a “third party manufacturing facility in Tampa, Florida not being ready for pre-approval inspection by the FDA.”
“We plan on refiling the NDA in January 2017, which is when we and the FDA have been advised by our contract manufacturer that they expect to be prepared for FDA inspection,” said Vicente Anido, Jr., PhD, chairman and CEO at Aerie.