Aerie submits NDA for Roclatan

Aerie Pharmaceuticals has submitted a new drug application to the FDA for Roclatan, its once-daily IOP-lowering eye drop, the company announced in a press release.
As a fixed-dose combination of two previously approved drugs, the expected FDA review period for Roclatan (netarsudil 0.02%/latanoprost 0.005% ophthalmic solution) is 10 months rather than 12 months under section 505(b)(2) of the Food, Drug and Cosmetic Act, the release said.
“We believe, if approved, Roclatan has the potential to be the most efficacious therapy in the market for the reduction of IOP, which makes this

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