Mirvaso (Galderma Laboratories, galderma.com) has become the first topical drug to gain FDA approval for the treatment of the redness or flushing common with rosacea, a chronic disorder that affects 16 million individuals according to the National Rosacea Society (rosacea.org).
“Rosacea is a condition we see often and, until now, we have been without a prescription treatment option to specifically address the persistent redness. It’s exciting to have a solution for at least some of these patients,” says Mark Jackson, MD, clinical professor of medicine, University of Louisville, a dermatologist and principle investigator on the phase 3 clinical trials of Mirvaso gel.
Brimonidine, the primary active in Mirvaso gel, is a vasoconstrictor, which has been used in ophthalmic solutions to treat angle-closure glaucoma and ocular hypertension. The topical gel constricts superficial dilated blood vessels, decreasing the redness caused by rosacea.
During two month-long phase 3 trials with Mirvaso both subjects with rosacea (550) and their treating physicians independently graded the severity of facial redness using: 4 for severe redness, 3 for moderate redness, 2 for mild redness, 1 for slight redness and 0 for clear. Only subjects with grade 4 redness were included in the study. Evaluations were made 30 minutes after the first daily application and regularly for the next 12 hours, while the subjects remained in the clinic. The subjects then took the medication home and applied it daily for one month, coming in at day 15 and day 29 for additional evaluations.
“Our primary end-point was a two-grade decrease in redness as independently judged by both the patient and the physician, which is a high bar to evaluate the effectiveness of the treatment,” says Dr. Jackson. “We did not take pictures of the patients before treatment, and so we were dependent on the subjects’ memory of their condition before treatment. Physicians recorded a higher percentage of subjects with a two-grade improvement, compared to subjects’ reported percentages, and 60% of both subjects and physicians recorded at least a one-grade improvement.
“The level of response was variable,” adds Dr. Jackson. “The responder rate with Mirvaso was significantly greater than with the placebo. And there was no loss of response over time; early responders continued to respond at the same level throughout the month-long trial.”
What about safety? In a long-term study of 276 subjects, Mirvaso was found to be safe and efficacious when used daily over the one-year duration of the study. Only 4% of the subjects reported adverse effects, according to literature from Galderma Laboratories.
“A few subjects experienced burning and stinging, which is not unusual for patients with rosacea, and a small percentage saw some worsening of their redness,” says Dr. Jackson, “but, overall, Mirvaso was safe and tolerable.”
Current treatments for rosacea differ depending on the patient’s symptoms. Until now physicians have had to rely on low-dose oral antibiotics, skin creams containing topical antibiotics and azelaic acid or clonidine, a blood pressure medication, all of which have shown some general ability to reduce redness. Treatments with intense pulsed light or vascular lasers offer good results but are too expensive for many patients.
As with many medications, repeat dosing is necessary. At this time Mirvaso is not covered by any insurance plans. Galderma plans to meet with managed care companies to discuss patient access to this first-in-class therapeutic option. The decision to cover any prescription drug is at the discretion of the managed care company. If patients get results, though, many will certainly be willing to pay out of pocket.
“Mirvaso finally gives us an option for those patients who continually ask for some treatment for the redness caused by rosacea,” concludes Dr. Jackson.
Linda W. Lewis is a contributing editor of MedEsthetics.
PHOTO COURTESY OF Galderma