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Rhopressa Approval History

  • FDA approved: Yes (First approved December 18th, 2017)
  • Brand name: Rhopressa
  • Generic name: netarsudil
  • Dosage form: Ophthalmic Solution
  • Company: Aerie Pharmaceuticals, Inc.
  • Treatment for: Glaucoma

Rhopressa (netarsudil ophthalmic solution) is a Rho kinase inhibitor for the treatment of open-angle glaucoma or ocular hypertension.

Information for Patients

  • Use one drop in the affected eye(s) once daily in the evening.
  • If a dose is missed, treatment should continue with the next dose in the evening.
  • Avoid allowing the tip of the dropper to contact the eye, surrounding structures, fingers, or any other surface in order to minimize contamination of the solution. Serious damage to the eye and subsequent loss of vision may result from using contaminated solutions.
  • Rhopressa contains benzalkonium chloride, which may be absorbed by soft contact lenses. Contact lenses should be removed prior to instillation of Rhopressa and may be reinserted 15 minutes following its administration.
  • If more than one topical ophthalmic drug is being used, the drugs should be administered at least 5 minutes between applications.

The most common side effect is eye redness. Other common side effects include corneal verticillata, pain at the instillation site, and conjunctival hemorrhage.

Development History and FDA Approval Process for Rhopressa

Dec 19, 2017Approval Aerie Pharmaceuticals Announces U.S. FDA Approval of Rhopressa (netarsudil ophthalmic solution) 0.02% for Patients with Open-Angle Glaucoma or Ocular Hypertension
Oct 13, 2017Aerie Pharmaceuticals Announces FDA Advisory Committee Vote in Favor of Rhopressa (netarsudil ophthalmic solution) 0.02%
May 15, 2017Aerie Pharmaceuticals Announces FDA Acceptance of NDA Submission for Rhopressa (netarsudil ophthalmic solution) 0.02%
Apr 12, 2017Aerie Pharmaceuticals Reports Positive Rocket 4 Six-Month Topline Safety and Efficacy Results for Rhopressa (netarsudil ophthalmic solution) 0.02%
Mar  1, 2017Aerie Pharmaceuticals Announces Resubmission of NDA for Rhopressa (netarsudil ophthalmic solution) 0.02%
Sep  6, 2016Aerie Pharmaceuticals Submits NDA to U.S. FDA for Rhopressa (netarsudil ophthalmic solution) 0.02%
Jun 16, 2016Aerie Pharmaceuticals Completes Enrollment of Rocket 4 Phase 3 Clinical Trial of Rhopressa (netarsudil ophthalmic solution) 0.02%

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.