Production & Manufacturing
Process & Production

FDA panel backs approval of Aerie’s Rhopressa for glaucoma treatment

PBR Staff Writer Published 16 October 2017

Aerie Pharmaceuticals’ Rhopressa (netarsudil ophthalmic solution) 0.02% has been recommended for approval by an advisory panel of the US Food and Drug Administration (FDA) for the treatment of glaucoma and ocular hypertension.

All the ten members of the FDA’s Dermatologic and Ophthalmic Drugs Advisory Committee voted in favor of netarsudil ophthalmic solution, which is intended to be used daily once.

As per the review, the panel agreed unanimously that clinical trials of netarsudil ophthalmic solution support its efficacy for reduction of elevated intraocular pressure (IOP) in patients having open-angle glaucoma or ocular hypertension.

Nine out of ten members agreed that the efficacy of Aerie’s ophthalmic solution had outweighed its safety risks during the clinical trials.

The panel’s recommendation will not be binding on the FDA which is expected to take a decision on Rhopressa approval by 28 February 2018.

Aerie chairman and CEO Vicente Anido said: “We are delighted with the outcome of the FDA’s Advisory Committee, and we now have our sights set on the February 28th PDUFA date.

“We believe there are significant unmet needs in the treatment of patients with open-angle glaucoma or ocular hypertension, and we are very excited about the prospects for Rhopressa.”

According to Aerie, Rhopressa particularly targets the trabecular meshwork and the diseased tissue which causes elevated intraocular pressure in glaucoma.

Rhopressa has been demonstrated during preclinical and clinical trials to have reduced episcleral venous pressure, which contributes nearly half of IOP in healthy people.

Based on the company’s preclinical studies, the eye drop solution may have an additional mechanism that decreases fluid production in the eye, resulting in lowered IOP.

Image: Aerie’s glaucoma drug is a step closer towards approval in the US after positive review from an FDA panel. Photo: courtesy of everydayplus/