13 November 2020 - European Commission Decision Anticipated in Approximately Two Months.
Aerie Pharmaceuticals today announced the EMA's CHMP has adopted a positive opinion recommending approval of the marketing authorisation application for Roclanda (netarsudil and latanoprost ophthalmic solution) 0.02%/0.005%.
The recommended indication is the reduction of elevated intra-ocular pressure in adult patients with primary open-angle glaucoma or ocular hypertension for whom monotherapy with a prostaglandin or netarsudil provides insufficient intra-ocular pressure reduction.