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Rocklatan FDA Approval History

Last updated by Judith Stewart, BPharm on March 27, 2019.

FDA Approved: Yes (First approved March 12, 2019)
Brand name: Rocklatan
Generic name: netarsudil and latanoprost
Dosage form: Ophthalmic Solution
Company: Aerie Pharmaceuticals, Inc.
Treatment for: Glaucoma, Open Angle, Intraocular Hypertension

Rocklatan (netarsudil and latanoprost ophthalmic solution) is a fixed dose combination of the Rho kinase inhibitor netarsudil (Rhopressa) and the prostaglandin F2α analogue latanoprost (Xalatan), indicated to reduce elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.

Development timeline for Rocklatan

Mar 12, 2019Approval FDA Approves Rocklatan (netarsudil and latanoprost ophthalmic solution) for the Reduction of Intraocular Pressure in Open-Angle Glaucoma or Ocular Hypertension
May 15, 2018Aerie Pharmaceuticals Submits NDA to FDA for Roclatan (netarsudil/latanoprost ophthalmic solution) 0.02%/0.005%
Jul 19, 2017Aerie Pharmaceuticals Reports Positive Roclatan (netarsudil/latanoprost ophthalmic solution) 0.02%/0.005% Phase 3 12-month Topline Safety Results

Further information

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