said Tuesday that the Food and Drug Administration approved label extensions for its moderate to severe facial wrinkle and fold treatments Juvederm Ultra and Juvederm Ultra Plus based on new clinical data, making them the only hyaluronic acid dermal fillers approved to last up to a year.
The Irvine, Calif., specialty pharmaceutical and medical device company that makes Botox said the extensions for the Juvederm injections were the result of follow-up data evaluating the longevity of clinical improvement in patients up to 1.5 years after the original six-month pivotal study evaluating the safety and efficacy of the products.
After the initial trial, which involved 292 patients, 225 of those subjects returned for complimentary follow-up treatment and were evaluated. Allergan said the mean level of improvement remained statistically significant for 75% of the Juvederm Ultra subjects and 81% of the Juvederm Ultra Plus subjects after nine months.
The company said 48 more patients enrolled in a second study following subjects after repeat treatment, with 78% of Juvederm Ultra subjects and 90% of Juvederm Ultra Plus subjects maintaining improvement one year after repeat treatment.
Throughout the study, no subjects discontinued treatment due to lack of effectiveness or adverse events, and no serious treatment-related adverse events were reported, according to the company.
"Patients are looking for longer-lasting, science-based products that fill in lines, such as the parentheses around the mouth, as part of their overall anti-aging skin care regimen," said Robert Grant, president of Allergan Medical, a division of Allergan.
Allergen was up $1, or 1.7%, to $59 Tuesday morning.