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Consider adding for consistent IOP reduction for more patients1,2

A REAL-WORLD EXPERIENCE TRIAL

M.O.S.T.: A Multi-center Open-label Study

Additional >4 mmHg IOP reduction whether added to a PGA monotherapy or combination therapy2

In a real-world setting, Rhopressa® provided consistent, additional IOP reduction regardless of the patient’s current regimen.2

M.O.S.T.: Change from Baseline (BL) in Mean IOP Over 12 Weeks

Study design: Rhopressa® Multi-center Open-label Study (M.O.S.T.)

M.O.S.T. (12-week), prospective, multi-center, non-comparative, open-label study of 260 subjects diagnosed with OAG or OHT.

Primary Endpoint:

  • Percent change from BL in mean IOP at Week 12

Secondary Endpoint:

  • Change from BL in mean IOP at Week 12
  • Mean IOP at Week 12

The most common ocular adverse event (AE) reported when Rhopressa® was used adjunctively was conjunctival hyperemia (19.9%), resulting in a discontinuation rate of 4.3%. Other common AEs were: blurred vision (6.2%), conjunctival hemorrhage (5.0%), and instillation site pain (5.0%).2

Patients achieved a consistent IOP reduction of ∼20% whether adding Rhopressa® to a PGA monotherapy or to a combination of therapies.2

Pooled ROCKET Phase 3 Studies

Consistent IOP reduction across a range of baseline IOPs1,5

Rhopressa® demonstrated up to 5 mmHg of consistent mean IOP reduction over a range of untreated baselines during pooled analysis.5,6

Pooled ROCKET: Change from Baseline (BL) in Mean IOP Over 3 Months

3.6 to 4.8 mmHg IOP reduction in patients with baseline IOPs <25 mmHg vs 3.7 to 5.1 mmHg with timolol2

Study design: ROCKET 1, 2 and 4:

Double-masked, parallel, noninferiority phase 3 studies of once-daily Rhopressa® (Netarsudil ophthalmic solution) 0.02% vs twice-daily timolol.5,6

Inclusion criteria5,6:

  • OHT or OAG
  • Unmedicated baseline IOP (post-washout*):
    • ROCKET 1 & 2; >20 to >27 mmHg 8:00 AM and >17 to <27 mmHg 10:00 AM and 4:00 PM
    • ROCKET 4; >20 to <30 mmHg 8:00 AM and >17 to <30 mmHg 10:00 AM and 4:00 PM

ROCKET 1 (3-month duration)

Rhopressa® QHS (n=202)

Timolol BID (n=209)

ROCKET 2 (12-month duration)

Rhopressa® QHS (n=251)

Rhopressa® BID (n=254)

Timolol BID (n=251)

ROCKET 4 (6-month duration)

Rhopressa® QHS (n=351)

Timolol BID (n=357)

Primary Endpoints5,6:

  • Mean IOP at 8:00 AM, 10:00 AM, and 4:00 PM at Week 2, Week 6, and Month 3
  • Noninferiority margin (95% CI)
    • <1.5 mm at all time points vs timolol
    • <1.0 mm for a majority of all time points vs timolol

The minimum washout period was 4 weeks for patients using prostaglandin analogs or beta-adrenoceptor antagonists prior to study entry, 2 weeks for those using adrenergic agonists, and 5 days for those using muscarinic agonists or carbonic anhydrase inhibitors.

View ROCK Inhibition

ROCK inhibitors are targeting and treating glaucoma differently. See the science behind the results.

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®.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

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®.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

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. Data on file, Aerie Pharmaceuticals, Inc.
  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. Managed Market Insights & Technology, May 2020.