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IMPORTANT SAFETY
INFORMATION

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We Put MIRVASO Topical Gel to the Test

Facial redness of rosacea was significantly diminished in clinical studies

In clinical trials, subjects who used MIRVASO® (brimonidine) topical gel, 0.33%* saw their redness diminished for up to 12 hours. And for many, redness began to fade fast—often in as little as 30 minutes. As with any treatment, results can vary.

During clinical trials, 1210 participants were exposed to MIRVASO Topical Gel. A total of 833 participants were treated for persistent facial redness of rosacea; 330 of those were treated once daily for 29 days in vehicle-controlled trials.

These photos show actual results from the two 8-week, phase 3, multicenter, randomized, vehicle-controlled studies evaluating the efficacy and safety of MIRVASO Topical Gel. Primary endpoint†: Subjects and researchers were asked to grade the improvement they saw at hours 3, 6, 9, and 12 following application. On day 29 of the trials, 2-grade improvement was observed with MIRVASO Topical Gel vs vehicle gel at hour 3 (28% vs 10%), at hour 6 (28% vs 9%), at hour 9 (22% vs 10%), and at hour 12 (22% vs 9%). Secondary endpoint†: Redness was visibly reduced in as early as 30 minutes for 28% of study participants (vs 6% of subjects using vehicle gel).

MIRVASO Topical Gel continued to reduce redness, month after month‡

In a 1-year clinical trial, subjects who used MIRVASO Topical Gel daily for at least 12 months had consistent results—from day 1 through day 365.‡ The most common side effects were flushing (10%), erythema (8%), worsening of rosacea (5%), nasopharyngitis (5%), skin burning sensation (4%), increased intraocular pressure (4%), and headache (4%).

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Study Participant #8076-001
Baseline
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Study Participant #8076-003
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Study Participant #8139-010
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Study Participant #8076-005
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Study Participant #8057-024
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Actual results with MIRVASO Topical Gel from 4-week clinical studies. Individual results may vary.

The safety and efficacy of MIRVASO Topical Gel was evaluated in 2 identical, randomized, vehicle-controlled trials with 553 subjects aged 18 years and older. Study participants were randomized 1:1 to receive either MIRVASO Topical Gel or vehicle gel once daily for 4 weeks. The primary endpoint for both studies was 2-grade composite success at hours 3, 6, 9, and 12 on day 29. The secondary endpoint was 1-grade composite success at 30 minutes on day 1. Composite success was defined as improvement on both the Clinician Erythema Assessment and Patient Self-Assessment.

Important Safety Information
Indication:  MIRVASO® (brimonidine) topical gel, 0.33%* is an alpha adrenergic agonist indicated for the topical treatment of persistent (nontransient) facial erythema of rosacea in adults 18 years of age or older. Adverse Events:  In clinical trials, the most common adverse reactions (≥1%) included erythema, flushing, skin burning sensation and contact dermatitis. Warnings/Precautions:  MIRVASO Topical Gel should be used with caution in patients with depression, cerebral or coronary insufficiency, Raynaud's phenomenon, orthostatic hypotension, thromboangiitis obliterans, scleroderma, or Sjögren’s syndrome. Alpha-2 adrenergic agents can lower blood pressure. MIRVASO Topical Gel should be used with caution in patients with severe or unstable or uncontrolled cardiovascular disease. Serious adverse reactions following accidental ingestion of MIRVASO Topical Gel by children have been reported. Keep MIRVASO Topical Gel out of reach of children. Not for oral, ophthalmic, or intravaginal use.

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.

Submitted by insite on Wed, 01/02/2019 - 15:23

*Each gram of gel contains 5 mg of brimonidine tartrate, equivalent to 3.3 mg of brimonidine free base.

†The long-term safety and efficacy of MIRVASO Topical Gel was evaluated in a 1-year, open-label, non-comparative study in 276 subjects with moderate to severe facial redness of rosacea who used MIRVASO Topical Gel once daily for at least 12 months.

‡The safety and efficacy of MIRVASO Topical Gel was evaluated in 2 identical, randomized, vehicle-controlled trials with 553 patients aged 18 years and older. Study participants were randomized 1:1 to receive either MIRVASO Topical Gel or vehicle gel once daily for 4 weeks. The primary endpoint for both studies was 2-grade composite success at hours 3, 6, 9, and 12 on day 29. The secondary endpoint was 1-grade composite success at 30 minutes on day 1. Composite success was defined as improvement on both the Clinician Erythema Assessment and Patient Self-Assessment.
 

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To get your MIRVASO Gel Patient Savings Card, click OK below. You will be redirected to an external website that is independently operated and not managed by Galderma Laboratories, L.P. Galderma assumes no responsibility for the site you are about to visit. If you do not wish to leave Mirvaso.com, click CANCEL. Otherwise, click OK to continue.

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Study Designs

Two 4-week pivotal studies

The safety and efficacy of MIRVASO® (brimonidine) topical gel, 0.33%* was evaluated in 2 identical, randomized, vehicle-controlled trials with 553 patients aged 18 years and older. Study participants were randomized 1:1 to receive either MIRVASO or vehicle gel once daily for 4 weeks. The primary endpoint for both studies was 2-grade composite success at hours 3, 6, 9, and 12 on day 29. The secondary endpoint was 1-grade composite success at 30 minutes on day 1. Composite success was defined as improvement on both the Clinician Erythema Assessment and Patient Self-Assessment.1

Long-term, open-label study

The long-term safety and efficacy of MIRVASO was studied in a 52-week, multicenter, open-label, non-comparative study with 449 patients with moderate to severe facial erythema of rosacea. The primary objective of the study was to evaluate the long-term safety of MIRVASO applied once daily for up to 12 months. The secondary objective of the study was to evaluate the long-term efficacy of MIRVASO applied once daily for up to 12 months.2

*Each gram of gel contains 5 mg of brimonidine tartrate, equivalent to 3.3 mg of brimonidine free base.

PROGRAM DETAILS:

The Galderma® CareConnect Program is brought to you by Galderma Laboratories, L.P. The Patient Savings Card provides savings on out‑of‑pocket expenses for up to a 30‑day supply of included Galderma products, as described below. If you have valid prescriptions for more than one Galderma product, the copay expense and savings apply to each product. You may use the Patient Savings Card once every 30 days, depending on when you last received a 30‑day supply of each Galderma product. Use of the Patient Savings Card does not obligate you to use or to continue using any Galderma product. You may use the Patient Savings Card at any participating pharmacy located in the United States.

The Galderma CareConnect Program Patient Savings Card may not be combined with any savings, discount, free trial, or other similar offer for the same prescription. The Patient Savings Card is not transferable and is void if reproduced. The Patient Savings Card is not health insurance. Limit one (1) Patient Savings Card per patient. The Galderma CareConnect Program Patient Savings Card has no cash value and will not be accepted outside of participating pharmacies in the United States. Please visit Galderma’s website for our privacy practices. Galderma reserves the right to revoke or amend this offer without notice at any time and to deny payment for noncompliance with the terms of this offer. This offer expires December 31, 2016, unless this offer is earlier terminated by Galderma.

Use of this Patient Savings Card is subject to applicable state and federal law, and is void where prohibited by law, rule or regulation. In the event an AB rated generic equivalent product becomes available for one of the Galderma products covered by this Patient Savings Card, this offer will become void in Massachusetts with respect to that Galderma product.

You are encouraged to report negative side effects of prescription drugs to the FDA.

By using the Galderma CareConnect Program Patient Savings Card, you acknowledge that you currently meet the following eligibility criteria:

  • You have a valid prescription for the Galderma product your copay and the savings apply to;
  • You have no insurance or are subject to a private insurance copay requirement for your prescription;
  • You are not enrolled in Medicare Part D, Medicaid, Medigap, VA, DOD, Tricare, or any other government-run or government sponsored health care program with a pharmacy benefit;
  • You are at least 18 years old; and
  • You reside in the United States.

Visit www.fda.gov/medwatch or call 1-800-FDA-1088.