A new treatment class for the reduction of elevated IOP1-3
The first FDA-approved ROCK inhibitor that is believed to improve trabecular meshwork outflow1,2,4
Targets a main cause of elevated IOP
Most treatments lower IOP by decreasing aqueous humor production or by increasing outflow through the uveoscleral pathway, ignoring the normal outflow pathway through the trabecular meshwork.4
Mechanism of Action
Rhopressa® is believed to work at the cellular level within the trabecular meshwork to improve outflow of aqueous humor6
promote actin-myosin contraction7
increase actin stress fibers and focal adhesions6
Rho kinase inhibitors
are believed to lower IOP by increasing aqueous humor outflow through the TM pathway6
Consistent IOP reduction across a range of baseline IOPs
Up to 5 mmHg IOP reduction at peak8
Once-daily Rhopressa® lowers IOP similarly to timolol BID in patients with baseline IOPs <25 mmHg8
Rhopressa® offers consistent IOP reduction even in patients with a low baseline.4
Patients treated with once-daily Rhopressa® experienced a reduction of IOP ranging from 3.9 mmHg to 4.1 mmHg4
Patients treated with twice-daily timolol experienced a reduction of IOP ranging from 3.5 mmHg to 4.6 mmHg4
New Treatment Option
Once-daily Rhopressa® is a new treatment option3
Safety profile established in >800 patients4
Rhopressa® had minimal systemic AEs and no contraindications, and the majority of AEs were mild3,4
The most common ocular AE observed in controlled clinical studies with Rhopressa® was conjunctival hyperemia, which was reported in 53% of patients. Other ocular adverse reactions (~20%) in these clinical studies included cornea verticillata, instillation site pain, and conjunctival hemorrhage.3
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1. US Department of Health and Human Services, Food and Drug Administration. Rhopressa approval letter 208254. Received December 18, 2017. 2. Serle JB, Katz LJ, McLaurin E, et al; and ROCKET-1 and ROCKET-2 Study Groups. Two phase 3 clinical trials comparing the safety and efficacy of netarsudil to timolol in patients with elevated intraocular pressure. Am J Ophthalmol. 2017;S0002-9394(17)30513-5. doi: 10.1016/j.ajo.2017.11.019. 3. Rhopressa [prescribing information]. Irvine, CA: Aerie Pharmaceuticals, Inc; 2017. 4. US Department of Health and Human Services, Food and Drug Administration Dermatologic and Ophthalmic Drugs Advisory Committee briefing document: NDA 208254. Published October 13, 2017. 5. McLaren NC, Moroi SE. Clinical implications of pharmacogenetics for glaucoma therapeutics. Pharmacogenetics J. 2003;3:197-210. 6. Wang SK, Chang RT. An emerging treatment option for glaucoma: rho kinase inhibitors. Clin Ophthalmol. 2014;8:883-890. 7. Mutsuki A, Masanori N, Kaibuchi K. Rho-kinase/ROCK: a key regulator of the cytoskeleton and cell polarity. Cytoskeleton (Hoboken). 2010;67(9):545-554. 8. Bacharach J, Heah T, Ramirez N, et al. AGS Poster. AR-13324 Ophthalmic Solution 0.02%: Topline Results of Two Phase 3 Clinical Studies in Patients with Open Angle Glaucoma and Ocular Hypertension. 2016. 9. Bansal R, Tsai J. Compliance/adherence to glaucoma medications—a challenge. J Curr Glaucoma Pract. 2007;1(2):22-25. 10. DoF A. 11. DoF B. 12. DoF C.
RHOPRESSA® (netarsudil ophthalmic solution) 0.02% is a Rho kinase inhibitor 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
Dosage and Administration: Twice a day dosing is not well tolerated and is not recommended. If RHOPRESSA® is to be used concomitantly with other topical ophthalmic drug products to lower IOP, administer each drug product at least 5 minutes apart.
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.
Adverse reactions: The most common ocular adverse reaction observed in controlled clinical studies with RHOPRESSA® dosed once daily was conjunctival hyperemia which was reported in 53% of patients. 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 in patients. Most corneal verticillata resolved upon discontinuation of treatment.