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A treatment for the reduction of elevated IOP1

The first FDA-approved ROCK inhibitor that is believed to improve trabecular meshwork outflow1

IOP, intraocular pressure; ROCK, rho-associated protein kinase.

Unmet Need

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.

IOP, intraocular pressure.

Mechanism of Action

Rhopressa® is believed to work at the cellular level within the trabecular meshwork to improve outflow of aqueous humor4

IOP, intraocular pressure; TM, trabecular meshwork.

IOP Reduction

Consistent IOP reduction across a range of baseline IOPs

  • Up to 5 mmHg IOP reduction in the three pivotal Phase 3 ROCKET studies6

  • Rocket baseline range: (> 17 to< 27/30 mmHg)

See full study design

Study design: ROCKET 1, 2, 47, 8

ROCKET 1, ROCKET 2, and ROCKET 4 were double-masked, parallel, noninferiority Phase 3 studies of once-daily Rhopressa® 0.02% vs twice-daily timolol.

Inclusion criteria:

  • Ocular hypertension or open-angle glaucoma

  • 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® QD (n=202)

    Timolol BID (n=209)

  • ROCKET 2 (12-month duration)

    Rhopressa® QD (n=251)

    Rhopressa® BID (n=254)

    Timolol BID (n=251)

  • ROCKET 4 (6-month duration)

    Rhopressa® QD (n=351)

    Timolol BID (n=357)

Primary Endpoints:

  • 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.

Achieve consistent IOP reduction across a range of baseline IOPs

  • Patients treated with once-daily Rhopressa® experienced a reduction of IOP ranging from 3.9 mmHg to 4.1 mmHg6

  • Patients treated with twice-daily timolol experienced a reduction of IOP ranging from 3.5 mmHg to 4.6 mmHg6

BID, twice daily; IOP, intraocular pressure; QD, once daily; SEM, standard error of the mean.

In another clinical trial, Rhopressa® demonstrated further IOP reduction9

In the MERCURY-1 trial, conducted to support the approval of Rocklatan® (netarsudil and latanoprost opthalmic solution) 0.02%/0.005%, Rhopressa® further demonstrated mean IOP reduction up to 6.1 mmHg6

  • Phase 3 studies, MERCURY-1 and MERCURY-2 both included a wide range of baseline IOPs (>17 to <36 mmHg) vs ROCKET trials9,10

See full study design

Study design: MERCURY-1 and MERCURY-29,10

MERCURY-1 (12-month) and MERCURY-2 (3-month) were double-masked, randomized, multicenter, active-controlled, parallel-group, Phase 3 studies of Rocklatan®, Rhopressa®, and latanoprost.

Inclusion criteria:

  • Age ≥18 years

  • Bilateral OAG or OHT

  • Unmedicated IOP (post-washout*):

    • >20 to <36 mmHg at 8:00 AM

    • >17 to <36 mmHg at 10:00 AM and 4:00 PM

  • MERCURY-1 (12-month duration, US only)

    Rocklatan® QD (n=238)

    Latanoprost QD (n=236)

    Rhopressa® QD (n=244)

  • MERCURY-2 (3-month duration, US and Canada)

    Rocklatan® QD (n=245)

    Latanoprost QD (n=250)

    Rhopressa® QD (n=255)

Primary Endpoints:

  • Mean IOP at 9 time points (8:00 AM, 10:00 AM, 4:00 PM at Week 2, Week 6, and Month 3)

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.

Treatment Option

Once-daily Rhopressa® is an innovative treatment option1

AE, adverse event; IOP, intraocular pressure; MOA, mechanism of action.

Safety

Safety profile established in >800 patients in Phase 3 pivotal Rocket studies7,8

Rhopressa® had minimal systemic AEs and no contraindications, and the majority of AEs were mild in Phase 3 trials7,8

The most common ocular AE observed in controlled clinical studies with Rhopressa® was conjunctival hyperemia, which was reported in 53% of patients. Six percent of patients discontinued therapy due to conjunctival hyperemia. Other ocular adverse reactions (~20%) in these clinical studies included cornea verticillata, instillation site pain, and conjunctival hemorrhage.1

AE, adverse event.

Savings

Rhopressa® Savings Offer

Help Your Patients Save on Rhopressa®*

Eligible patients can reduce the cost of their prescription from the start with the Rhopressa® Savings Card.

  • Pay as
    little as
    $25*

    with eligible commercial insurance where Rhopressa® is covered

  • Pay as
    little as
    $50*

    with eligible commercial insurance where Rhopressa® is not covered

Download the Rhopressa® Savings Card and instruct patients to present it to the pharmacist with their prescription.

Download the Rhopressa® Savings Card

Restrictions apply. Patients with State or Federal prescription coverage, such as Medicare or Medicaid, are excluded.

See Terms and conditions

Patient Instructions: In order to redeem this offer you must have a valid prescription for Rocklatan® or Rhopressa®. This offer may not be redeemed for cash. By using this offer, you are certifying that you meet the eligibility criteria and will comply with the terms and conditions described in the Restrictions section below. Patients who are enrolled in a state or federally funded prescription insurance program, such as Medicare or Medicaid, are excluded. Patients with questions about the Rocklatan® or Rhopressa® Savings offer should call 1-844-807-9706.

Eligible commercially insured patients with coverage for Rocklatan® or Rhopressa® will pay the first $25 per 30-day supply, maximum savings limit applies; patient out-of-pocket expense may vary. Offer valid up to 12 qualifying prescriptions.

Eligible commercially insured patients who are not covered for Rocklatan® or Rhopressa® will pay the first $50 per 30-day supply, maximum savings limit applies; patient out-of-pocket expense may vary. Offer valid for up to 6 qualifying prescriptions.

Pharmacist instructions for patients with commercial insurance coverage for Rocklatan® or Rhopressa®: Submit the claim to the primary commercial insurance company first, then submit the balance due to CHANGE HEALTHCARE as a Secondary Payer COB with patient responsibility amount and a valid Other Coverage Code of 8. The patient is responsible for the first $25. Reimbursement will be received from CHANGE HEALTHCARE.

Pharmacist instructions for patients with commercial insurance that are not covered: Submit this claim to CHANGE HEALTHCARE. A valid Other Coverage Code of 3 is required. The patient is responsible for the first $50. Reimbursement will be received from CHANGE HEALTHCARE.

For any questions regarding CHANGE HEALTHCARE online processing, please call the Help Desk 1-800-433-4893.

Restrictions: This offer is valid for eligible residents of the United States only. This offer is void in U.S. territories including, but not limited to, Puerto Rico. Offer not valid for prescriptions reimbursed under Medicare, a Medicaid drug benefit plan, TRICARE, CHAMPUS or other federal or state health programs. Offer may not be combined with any savings, discount, trial or similar offer for the same prescription. No other purchase is necessary. Coupon is not insurance. By using this offer, the patient certifies that he or she will comply with any terms of his or her health insurance contract requiring notification to his or her payor of the existence and/or value of this offer. Offer not valid for patients under 18 years of age. It is illegal to (or offer to) sell, purchase, trade, or counterfeit this offer. This offer is not transferable. Void where prohibited by law. Absent a change in Massachusetts law, for Massachusetts residents only, this offer will expire on December 31, 2019. Program managed by ConnectiveRx on behalf of Aerie Pharmaceuticals. Aerie Pharmaceuticals reserves the right to rescind, revoke or amend this offer without notice at any time.

BY USING THIS CARD, YOU AND YOUR PHARMACIST UNDERSTAND AND AGREE TO COMPLY WITH THESE ELIGIBILITY REQUIREMENTS AND TERMS OF USE.

References

1. Rhopressa [prescribing information]. Irvine, CA: Aerie Pharmaceuticals, Inc; 2019. 2. Asrani S, McKee H, Scott B, et al. Pooled Phase 3 efficacy analysis of a once-daily fixed dose combination of netarsudil 0.02% and latanoprost 0.005% in ocular hypertension and open-angle glaucoma. Presented at the 13th Biennial Meeting of the European Glaucoma Society, March 2018. 3. McLaren NC, Moroi SE. Clinical implications of pharmacogenetics for glaucoma therapeutics. Pharmacogenetics J. 2003;3:197-210. 4. Wang SK, Chang RT. An emerging treatment option for glaucoma: rho kinase inhibitors. Clin Ophthalmol. 2014;8:883-890. 5. 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. 6. Data on File, Aerie Pharmaceuticals, Inc. 7. 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: Rho kinase elevated IOP treatment Trial 1 and 2 (ROCKET-1 and ROCKET-2). Am J Ophthalmol. 2018;186:116-127. 8. 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. pii: S0002-9394(19)30098-4. doi: 10.1016/j.ajo.2019.03.002. [Epub ahead of print] PubMed PMID: 30862500. 9. Brubaker J, Teymoorian S, Lewis R, et al. Once-daily fixed-dose combination of netarsudil 0.02% and latanoprost 0.005% in ocular hypertension/open angle glaucoma: 12-month data from MERCURY-1. Presented at the 28th Meeting of the American Glaucoma Society, March 2018. 10. Walters T, Ahmed I, Lewis R, et al. Once-daily fixed-dose combination of netarsudil 0.02% and latanoprost 0.005% in ocular hypertension or open-angle glaucoma, the MERCURY-2 study. Presented at the 28th Meeting of the American Glaucoma Society, March 2018.

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.