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Rocklatan Approval History

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 analog latanoprost (Xalatan) indicated to reduce elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.

Development History and FDA Approval Process for Rocklatan

DateArticle
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
May 24, 2017Aerie Pharmaceuticals Reports Positive Roclatan (netarsudil/latanoprost ophthalmic solution) 0.02%/0.005% Phase 3 Topline Efficacy Results
Sep 14, 2016Aerie Pharmaceuticals Reports Positive Roclatan (netarsudil/latanoprost ophthalmic solution) 0.02%/0.005% Phase 3 Topline Efficacy Results
Mar 28, 2016Aerie Pharmaceuticals Initiates Second Phase 3 Registration Trial of Roclatan (netarsudil/latanoprost ophthalmic solution) 0.02%/0.005%

Further information

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