EMA Panel Backs Roclanda Eyedrops, New Option for Glaucoma

EMA Panel Backs Roclanda Eyedrops, New Option for Glaucoma
The European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) has recommended approval of the fixed-dose combination of latanoprost and netarsudil (Roclanda).

The ophthalmic solution is indicated to decrease elevated intraocular pressure (IOP) in adults with primary open-angle glaucoma or ocular hypertension for whom monotherapy with a prostaglandin or netarsudil fails, according to an EMA news release.

Latanoprost is a prostaglandin analogue, and netarsudil is a Rho kinase inhibitor.

Roclanda will be available as 50 µg/ml / 200 µg/ml solution, administered as eyedrops.

Detailed recommendations for the use of latanoprost/netarsudil eyedrops will be described in the summary of product characteristics, which will be published in the European public assessment report and will be made available in all official European Union languages after marketing authorization has been granted by the European Commission.

The US Food and Drug Administration (FDA) approved the latanoprost/netarsudil combination (Rocklatan) in 2019 to decrease elevated IOP in patients with open-angle glaucoma or ocular hypertension.

The FDA approval of the netarsudil/latanoprost ophthalmic solution was supported by data from two phase 3 clinical trials, known as MERCURY 1 and MERCURY 2.

In both studies, the drug achieved the primary 90-day efficacy endpoint as well as positive 12-month safety and efficacy results, demonstrating statistically superior IOP reduction over latanoprost and netarsudil at every measured time point, as reported by Medscape Medical News.

In the two studies, more than 60% of patients who received the latanoprost/netarsudil ophthalmic solution achieved a reduction of IOP of 30% or more, which was nearly twice the percentage of participants who achieved that with latanoprost alone.

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