Rhopressa formally recommended for approval in USA

Following the release of positive briefing papers last week, the FDA’s advisory panel has formally recommended to the American regulator that it approve Aerie Pharmaceuticals glaucoma candidate Rhopressa (netarsudil).

The panel voted unanimously that data from the ROCKET trials supported the efficacy of Rhopressa for reducing elevated intraocular pressure, and nine to one that the benefits outweighed any safety risks.

Rhopressa is a potential first-in-class therapy that works by targeting the trabecular network, the main route through which fluid can flow away from the eye.

While the FDA is not obliged to follow the recommendation of its advisory panel, it normally does.