Aerie Pharmaceuticals (NSDQ:AERI) said today that it resubmit a New Drug Application for the company’s Rhopressa eye drops. The Irvine, Calif.-based company’s NDA was withdrawn in October last year, after a contract manufacturer was not prepared for its pre-approval inspection.
Aerie’s Rhopressa eye drops specifically target the eye’s trabecular network – the diseased tissue responsible for elevated intraocular pressure in patients with glaucoma.
The company said that if the eye drops are approved, the product would be the only once-daily therapy to target the trabecular network.
“We are delighted to have our Rhopressa NDA filing back on track, and we expect a standard 12-month FDA review process from the date of resubmission. Pending approval, we anticipate product launch in the second quarter of 2018,” chairman & CEO Vicente Anido, Jr. said in prepared remarks. “Looking forward to additional upcoming milestones, we continue to expect in the 2nd quarter of 2017, the readout of the six-month safety and efficacy data for the Rhopressa Phase III registration trial, known as Rocket 4. We also anticipate in the 2nd quarter of 2017, the readout of the 90-day efficacy data from Mercury 2, our 2nd Phase III registration trial for Roclatan (netarsudil/latanoprost ophthalmic solution) 0.02%/0.005%.”
In December, Aerie said that it completed enrollment for its 2nd phase III registration trial, Mercury 2, evaluating its Roclatan once-daily eye drops for intraocular pressure resulting from glaucoma or ocular hypertension.
The company’s Roclatan solution is a fixed dose combination of its drug Rhopressa (netarsudil ophthalmic solution) and latanoprost, a widely prescribed prostaglandin analogue. More than 690 patients are enrolled in the 3-arm study, comparing the Roclatan solution to each of its individual components.
In September, the company touted successful topline efficacy results from its 1st phase III registration trial, Mercury 1, for Roclatan.
The trial achieved its primary efficacy endpoint, demonstrating superiority over its components. Aerie said it will launch a 3rd phase III registration trial for Roclatan in the 1st half of 2017, which will be designed to support regulatory approval and commercialization efforts in Europe.