Galderma Laboratories, LP, has announced the publication of the long-term efficacy and safety results of a 1-year, open-label, non-comparative study of Mirvaso® (brimonidine) Topical Gel, 0.33% in patients with moderate to severe facial erythema (redness) of rosacea.
The results of this study, in which 276 subjects applied Mirvaso for at least 1 year, demonstrate that Mirvaso is safe and effective when used once-daily for up to 12 months. The study results were published in the January issue of Journal of Drugs in Dermatology.
‘The positive results of this long-term study provide additional evidence of the efficacy and safety of Mirvaso for patients with the persistent facial redness of rosacea,’ said Humberto Antunes, President and CEO, Galderma Laboratories.
‘Since we launched Mirvaso commercially in the United States in September 2013, we have seen widespread adoption by dermatologists, underscoring the important need for an effective topical prescription treatment for this most common symptom of rosacea.’
In addition to the long-term study, the approval of Mirvaso was also based on results from two identical randomised, vehicle-controlled pivotal 8-week studies in a total of 553 subjects, 269 of those treated once daily with Mirvaso for 29 days followed by a 4-week follow-up period. These studies demonstrated that Mirvaso was safe and effective for the treatment of persistent, non-transient facial erythema of rosacea when applied once daily.
Mirvaso was approved by the US Food and Drug Administration in August 2013 as the first and only topical treatment indicated for the persistent facial erythema of rosacea in adults aged 18 years of age or older.
Long-term study design
The study was conducted at 27 centres in the United States. Subjects with moderate to severe erythema of rosacea were instructed to apply topical Mirvaso once daily for up to 12 months, during which the severity of erythema and adverse events were evaluated.
In this study, subjects were allowed to use other rosacea therapies (oral and topical) in addition to Mirvaso. A total of 449 subjects were enrolled and 276 subjects applied Mirvaso for at least 1 year.
Long-Term Study Results
With regard to efficacy, the results showed that Mirvaso was effective in reducing the persistent facial erythema of rosacea on day 1 of treatment and consistent results were observed throughout the 12-month study. In addition, no evidence of tachyphylaxis (a sudden decease in response after drug administration compared to prior usage) was reported.
With regard to safety, no new major safety findings were observed in this study as compared to the vehicle-controlled pivotal studies. The most common adverse events (≥4% of subjects) were flushing (10%), erythema (8%), worsening of rosacea (5%), nasopharyngitis (5%), skin burning sensation (4%), increased intraocular pressure (4%), and headache (4%).