Key clinical-trial evidence for brimonidine

Author: Anoma Ranaweera B.V.Sc; PhD (Clinical Biochemistry, University of Liverpool, UK), 2013.

Introduction

On August 26, 2013, the U. S. Food and Drug Administration (FDA) approved brimonidine (Mirvaso®) topical gel, 0.33%* (Galderma Laboratories, Texas, USA) for the topical treatment of persistent (non-transient) facial erythema (redness) of rosacea in adults 18 years of age or older.

It is the first and only FDA-approved topical treatment specifically developed and indicated for persistent facial erythema in rosacea.

Clinical trial evidence for brimonidine

The approval of brimonidine topical gel was based on data collected from more than 550 patients enrolled in two phase 3 clinical studies, each of one-month duration. The results from both studies showed that adults who used Mirvaso demonstrated significantly greater improvement in the facial redness of rosacea than vehicle gel. In addition, a long-term study in 276 subjects who used brimonidine topical gel for up to 12-months was also conducted.

Short-term studies 1 and 2

Key efficacy findings are summarised in the table and figures below.

Success*Study 1Study 2
  Mirvaso® topical gel (N=129) Vehicle gel (N=131) Mirvaso® topical gel (N=148) Vehicle gel (N=145)
Hour 3 31% 11% 25% 9%
Hour 6 30% 10% 25% 9%
Hour 9 26% 10% 18% 11%
Hour 12 23% 9% 22% 10%

*2-grade improvement on CEA and 2-grade improvement on PSA scale on day 29

Adverse reactions in studies 1 and 2

Adverse reactions reported in 330 individuals treated with topical brimonidine gel applied once daily for 29 days are summarised in the table below.

Adverse reactions reported in clinical trials by at least 1% of subjects treated for 29 days
Mirvaso® topical gel (N=330) No. patients (%)Vehicle gel (N=331) No. patients (%)
Erythema 12 (4%) 3 (1%)
Flushing 9 (3%) 0
Skin burning sensation 5 (2%) 2 (1%)
Dermatitis 3 (1%) 1 (<1%)
Paraesthesia (tingling/prickly) 2 (1%) 1 (<1%)
Acne 2 (1%) 1 (<1%)
Vision blurred 2 (1%) 0
Nasal congestion 2 (1%) 0

Open-label long-term study

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