The Food and Drug Administration (FDA) has approved Rocklatan (netarsudil 0.02% and latanoprost 0.005% ophthalmic solution; Aerie) for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.

Rocklatan is a fixed-dose combination of a Rho kinase inhibitor and a prostaglandin F analogue; each of these components decreases elevated IOP by increasing the outflow of aqueous humor. The approval was based on data from two phase 3 clinical trials in which patients with open-angle glaucoma and ocular hypertension were randomized to receive Rocklatan, netarsudil 0.02%, or latanoprost 0.005% once daily.

Results showed that the average IOP lowering effect of Rocklatan was 1–3mmHg greater than monotherapy with either netarsudil or latanoprost throughout 3 months, with reductions maintained throughout 12 months. Across both studies, more than 60% of patients treated with the combination product achieved a reduction in IOP of ≥30%. The most common adverse effect reported in clinical trials was conjunctival hyperemia.

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Rocklatan 0.02%/0.005% ophthalmic solution will be supplied as a 2.5mL fill in a 4mL container. It is expected to be available in the second quarter of 2019.

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