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
- Both studies were randomized, double-blind, vehicle-controlled clinical trials.
- The trials included 553 subjects aged 18 years and older with moderate or severe persistent facial erythema of rosacea.
- Patients were treated once daily for 4 weeks with either Mirvaso topical gel or vehicle.
- Overall, 99% of subjects were Caucasian and 76% were female.
- Baseline disease severity was graded using a 5-point Clinician's Erythema Assessment (CEA) scale and a 5-point Patient Self Assessment (PSA) scale, on which subjects scored either “moderate” or “severe” on both scales.
- The primary efficacy endpoint in both pivotal trials was 2-grade Composite Success, defined as the proportion of subjects with a 2-grade improvement on both CEA and PSA measured at hours 3, 6, 9, and 12 on Day 29.
- In addition to Day 29, efficacy was evaluated on Day 15 and Day 1.
Key efficacy findings are summarised in the table and figures below.
| Success* | Study 1 | Study 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.
| 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
- An open-label study of brimonidine topical gel when applied once daily for up to one year was conducted individuals with persistent (nontransient) facial erythema of rosacea.
- Patients were allowed to use other rosacea therapies.
- A total of 276 subjects applied brimonidine topical gel for at least one year.
- The most common adverse events reported were flushing (10%), erythema (8%), increased rosacea (5%), nasopharyngitis (5%), skin burning sensation (4%), increased intraocular pressure (4%), and headache (4%).
We suggest you refer to your national drug approval agency such as the Australian Therapeutic Goods Administration (TGA), US Food and Drug Administration (FDA), UK Medicines and Healthcare products regulatory agency (MHRA) / emc, and NZ Medsafe, or a national or state-approved formulary eg, the New Zealand Formulary (NZF) and New Zealand Formulary for Children (NZFC) and the British National Formulary (BNF) and British National Formulary for Children (BNFC).