After setbacks and years of clinical testing, Aerie Pharmaceuticals has received FDA approval of Rhopressa (netarsudil ophthalmic solution .02%) for the lowering of elevated IOP in patients with open-angle glaucoma or ocular hypertension. The FDA approval decision was made 2 months ahead of the scheduled Prescription Drug User Fee Act (PDUFA) goal date of February 28, 2018.
“It's been a long road and it's hard to almost fathom the fact that all the way back in 2005 when Doctor David Epstein, the chair of ophthalmology at Duke at the time, was thinking that we should have a drug that once-a-day treats the trabecular meshwork, which is the underlying cause,” Vicente Anido Jr, PhD, Chairman and Chief Executive Officer at Aerie, said in an interview with Eyewiretoday.com. “After all these years to actually have the first product come through our pipeline and out, and getting it approved, is a tribute to him and I think certainly is going to be a great value to the doctors and the patients that are going to be receiving the drug.”
Aerie says that Rhopressa is the only once-daily product available that specifically targets the trabecular meshwork. Preclinical and clinical studies have demonstrated that Rhopressa lowers episcleral venous pressure, which contributes to approximately half of IOP in healthy subjects. The approval was based on data from the phase 3 Rocket 1, Rocket 2, and Rocket 4 studies, comparing once-daily Rhopressa to twice-daily timolol.
Dr. Anido said that Aerie has been preparing for commercialization for more than a year.
“Over the last 12 months we have been adding staff to our commercial team, which is now headed up by Judy Robertson, who is our chief commercial officer,” Dr. Anido said. “She brought in an incredibly talented group of folks from all the relevant companies in ophthalmology, [who are] so rich experience in a number of different settings, launching multiple different drugs, etc. And so that team has now been planning for the launch for quite some time.”
Dr. Anido said that Aerie will hire a sales force of 100 sales representatives early in the first quarter of 2018, and plans to launch Rhopressa by mid-second quarter of 2018.
Aerie is currently working to gain formulary coverage for commercial plans, which represent approximately half of the US market. The other half of the US market is covered through Medicare Part D, and the company expects its formulary presence for the Medicare market to commence in January 2019.
“We expect to reach somewhere between 12,000 and 14,000 eye care professionals that write glaucoma prescriptions,” he said.
Dr. Anido added that Aerie remains on track to file a new drug application for its second glaucoma drug Roclatan (netarsudil 0.02%/latanoprost 0.005% ophthalmic solution) to the FDA in second quarter 2018.