Reviewers Cite Rhopressa Efficacy

FDA medical reviewers say that Aerie Pharmaceuticals’ Rhopressa (netarsudil ophthalmic solution 0.02%) is effective for its proposed indication of reducing elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension. A briefing document released in advance of a 10/13 meeting of the FDA Dermatologic and Ophthalmic Drugs Advisory Company to consider the sponsor’s application says Rhopressa is a Rho kinase inhibitor, a new class of medications proposed to lower intraocular pressure by directly increasing trabecular outflow.

Issues FDA is asking the advisory committee to consider are: 

•          whether the drug’s clinical trials support its efficacy for reducing elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension;
•          whether the drug’s efficacy as demonstrated in the clinical trials outweighs the safety risks identified for it; and
•          suggestions for the product’s draft labeling.