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FDA committee gives push forward for Aerie's Rhopressa
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The FDA’s Dermatologic and Ophthalmic Drugs Advisory Committee voted favorably on questions of efficacy regarding Aerie Pharmaceuticals’ glaucoma drug Rhopressa.
Rhopressa (netarsudil ophthalmic solution 0.02%) is a once-daily eye drop designed to lower IOP in patients with open-angle glaucoma or ocular hypertension by targeting the trabecular meshwork.
The panel voted 10 yes, zero no and zero abstentions on the following question: Do the clinical trials support the efficacy of netarsudil ophthalmic solution for reducing elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension?
“Yes, I also based it on ocular hypertension patients that might have pressures of 26 mm Hg and open-angle glaucoma,” Mildred Olivier, MD, FACS, of Rosalind Franklin University, Chicago, said at the meeting.
Tonya King, PhD, of Pennsylvania State University College of Medicine, echoed Olivier’s comments and noted the evidence supported its use on a subset of patients with a starting baseline pressure of less than 25 mm Hg.
The panel voted nine yes, one no and zero abstentions on a second question: Does the efficacy of netarsudil ophthalmic solution, demonstrated in the clinical trials, outweigh the safety risks identified for the drug product?
King cast the lone no vote for the question.
“I voted no. Although the sponsors seemed to adequately discuss the severity of the adverse events, it seems to me that the high discontinuation rate is still a concern,” she said.
Young H. Kwon, MD, PhD, of University of Iowa Health Care, also noted the high rate of discontinuation and side effects in the trial, but cast a yes vote for the second question.
“Despite the higher rate of side effects and discontinuation rate, this represents a major advance in glaucoma therapy because it represents the first in a new class of glaucoma medications and therefore my vote of yes,” he said.
In the results of the Rocket 2 phase 3 registration trial of Rhopressa, Aerie reported the most common adverse event was hyperemia, which increased in 35% of patients in the trial and was scored as mild for 83% of patients in the Rhopressa once-daily arm, according to a company press release.
Vicente Anido Jr., PhD, chairman and CEO at Aerie Pharmaceuticals, told Healio.com/OSN he was “obviously very pleased” with the results of the votes.
“We’re ecstatic that things can move forward and certainly expect to continue to work with the FDA between now and the PDUFA date to try to get this thing approved as soon as we can get it done,” he said.
The results of two phase 3 registration trials, Rocket 2 and Rocket 1, for Rhopressa were included in Aerie’s new drug application (NDA) to the FDA in February 2017. Aerie also included the 90-day efficacy results of Rocket 4, a phase 3 registration trial for Rhopressa, and Mercury 1, a phase 3 registration trial for Aerie product candidate Roclatan (netarsudil 0.02%, latanoprost ophthalmic solution 0.005%) in the NDA submission as supportive, according to the release.
The FDA set a Prescription Drug User Fee Act goal date of Feb. 28, 2018, for the completion of its review. – by Robert Linnehan
Reference:
FDA Center for Drug Evaluation and Research. Dermatologic and Ophthalmologic Drugs Advisory Committee meeting; Oct. 13, 2017; Silver Spring, Md.