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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.

  • Rocklatan is administered by instilling one drop into the affected eye(s) once daily in the evening.
  • One of the ingredients contained in Rocklatan (latanoprost) has the potential to cause increased brown pigmentation of the iris, which may be permanent. There is also a possibility of eyelid skin darkening, which may be reversible upon discontinuation of treatment.
  • Rocklatan may also cause changes to the eyelashes, including increased length, thickness and number of lashes. Eyelash changes are usually reversible upon discontinuation of treatment.
  • The most commonly reported adverse reaction is conjunctival hyperemia (eye redness). Other common adverse reactions include instillation site pain, corneal verticillata, and conjunctival hemorrhage.

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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