Roclanda recommended for approval in European Union
The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of Roclanda, according to a press release from Aerie Pharmaceuticals.
Roclanda (netarsudil 0.02% and latanoprost 0.005% ophthalmic solution) would be indicated for the reduction of elevated IOP in adults with primary open-angle glaucoma or ocular hypertension for whom monotherapy provided insufficient IOP reduction.
“We are delighted that the CHMP has adopted a positive opinion for Roclanda,” Vicente Anido Jr., PhD, chairman and CEO of Aerie, said in the release. “We look forward to the European Commission’s final decision on the MAA for Roclanda, which is expected by early next year.”
The final decision will be applicable to all European Union member states and Iceland, Norway and Liechtenstein.
Roclanda is marketed as Rocklatan in the United States.
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