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IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

Bacterial Keratitis: There have been reports of bacterial keratitis associated with the use of multiple-dose containers of topical ophthalmic products. These containers had been inadvertently contaminated by patients who, in most cases, had a concurrent corneal disease or a disruption of the ocular epithelial surface.

Contact Lenses: Contact lenses should be removed prior to instillation of Rhopressa® and may be inserted 15 minutes following its administration.

ADVERSE REACTIONS

The most common ocular adverse reaction observed in controlled clinical studies with Rhopressa® dosed once daily was conjunctival hyperemia, reported in 53% of patients. Six percent of patients discontinued therapy due to conjunctival hyperemia. Other common (approximately 20%) adverse reactions were: corneal verticillata, instillation site pain, and conjunctival hemorrhage. Instillation site erythema, corneal staining, blurred vision, increased lacrimation, erythema of eyelid, and reduced visual acuity were reported in 5-10% of patients.

The corneal verticillata seen in Rhopressa®- treated patients were first noted at 4 weeks of daily dosing. This reaction did not result in any apparent visual functional changes. Most corneal verticillata resolved upon discontinuation of treatment.

Please click here for full prescribing information for Rhopressa®.

To report Suspected Adverse Reactions, contact Aerie Pharmaceuticals, Inc. at 1-855-740-1924 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

INDICATIONS AND USAGE

Rhopressa® (netarsudil ophthalmic solution) 0.02% is indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension.

DOSAGE AND ADMINISTRATION

The recommended dosage is one drop in the affected eye(s) once daily in the evening.

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

Bacterial Keratitis: There have been reports of bacterial keratitis associated with the use of multiple-dose containers of topical ophthalmic products. These containers had been inadvertently contaminated by patients who, in most cases, had a concurrent corneal disease or a disruption of the ocular epithelial surface.

Contact Lenses: Contact lenses should be removed prior to instillation of Rhopressa® and may be inserted 15 minutes following its administration.

ADVERSE REACTIONS

The most common ocular adverse reaction observed in controlled clinical studies with Rhopressa® dosed once daily was conjunctival hyperemia, reported in 53% of patients. Six percent of patients discontinued therapy due to conjunctival hyperemia. Other common (approximately 20%) adverse reactions were: corneal verticillata, instillation site pain, and conjunctival hemorrhage. Instillation site erythema, corneal staining, blurred vision, increased lacrimation, erythema of eyelid, and reduced visual acuity were reported in 5-10% of patients.

The corneal verticillata seen in Rhopressa®- treated patients were first noted at 4 weeks of daily dosing. This reaction did not result in any apparent visual functional changes. Most corneal verticillata resolved upon discontinuation of treatment.

Please click here for full prescribing information for Rhopressa®.

To report Suspected Adverse Reactions, contact Aerie Pharmaceuticals, Inc. at 1-855-740-1924 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

INDICATIONS AND USAGE

Rhopressa® (netarsudil ophthalmic solution) 0.02% is indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension.

DOSAGE AND ADMINISTRATION

The recommended dosage is one drop in the affected eye(s) once daily in the evening.

References:

  1. Rhopressa® (netarsudil ophthalmic solution) 0.02% Prescribing Information, Aerie Pharmaceuticals, Inc., Irvine, Calif. 2019.
  2. Zaman F, Gieser SC, Schwartz GF, Swan C, Williams JM. A multicenter, open-label study of netarsudil for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension in a real-world setting. Curr Med Res Opin. 2021;37(6):1011-1020.
  3. Kazemi A, McLaren J, Kopczynski C, et al. The effects of netarsudil ophthalmic solution on aqueous humor dynamics in a randomized study in humans. J Ocul Pharmacol Ther. 2018;34(5):380-386.
  4. Prum B Jr, Rosenberg L, Gedde S, et al. Primary Open-Angle Glaucoma Preferred Practice Pattern guidelines. Ophthalmology. 2016;123(1):P41-P111.
  5. Serle JB, Katz LJ, McLaurin E, et al. Two Phase 3 clinical trials comparing the safety and efficacy of netarsudil to timolol in patients with elevated intraocular pressure: Rho kinase elevated IOP treatment Trial 1 and 2 (ROCKET-1 and ROCKET-2). Am J Ophthalmol. 2018;186:116-127.
  6. Khouri AS, Serle JB, Bacharach J, et al; for the ROCKET-4 Study Group. Once-daily netarsudil vs twice-daily timolol in patients with elevated intraocular pressure: the randomized phase 3 ROCKET-4 study. Am J Ophthalmol. 2019;204:97-104.
  7. Wang R, Williamson J, Kopczynski C, Serle J. Effect of 0.04% AR-13324, a ROCK, and norepinephrine transporter inhibitor, on aqueous humor dynamics in normotensive monkey eyes. J Glaucoma. 2015;24(1):51-54.
  8. Ren R, Li G, Le TD, Kopczynski C, Stamer WD, Gong H. Netarsudil increases outflow facility in human eyes through multiple mechanism. IOVS. 2016;(57)14:6197-6209.
  9. Sit A, Gupta D, Kazemi A, et al. Improvement of trabecular outflow facility by netarsudil ophthalmic solution in patients with primary open angle glaucoma or ocular hypertension. Presented at The Association for Research in Vision and Ophthalmology 2019 Annual Meeting (ARVO 2019). April 28-May 2, 2019; Vancouver, BC, Canada.
  10. Rocklatan® (netarsudil and latanoprost ophthalmic solution) 0.02%/0.005% Prescribing Information, Aerie Pharmaceuticals, Inc., Irvine, Calif. 2020.
  11. Malihi M, Sit AJ. Aqueous humor dynamics and implications for clinical practice. Int Ophthalmol Clin. 2011;51(3):119-139.
  12. Chang TCP, Freedman S. Glaucoma: Medications. Glaucoma. 2015:1-8.
  13. Higginbotham E. Considerations in glaucoma therapy: fixed combinations versus their component medications. Clin Ophthalmol.
  14. Robin AL, Covert D. Does adjunctive glaucoma therapy affect adherence to the initial primary therapy? Ophthalmology. 2005 May;112(5):863-8.
  15. Robin A, Grover DS. Compliance and adherence in glaucoma management. Indian J Ophthalmol. 2011 Jan;59 Suppl(Suppl1):S93-6.
  16. Managed Market Insights & Technology, LLC. Accessed on July 2, 2021.