The US Food and Drug Administration (FDA) has given its nod to Allergan’s JUVÉDERM® ULTRA XC for lip augmentation in adults over the age of 21.
JUVÉDERM® ULTRA XC instantly adds fullness to the lips and is the only dermal filler that has proven results lasting up to 1 year for lip augmentation.
In clinical trials of JUVÉDERM® ULTRA XC, the majority of subjects reported improvement in the softness, smoothness, and natural look and feel of their lips through 1 year. In clinical trials, 79% of subjects showed a meaningful improvement in lip fullness 3 months after treatment. Additionally, more than 78% of subjects reported an improvement in their overall satisfaction with the look and feel of their lips at 1 year after treatment.
Revance Therapeutics Inc is now dosing patients for a Phase 3 pivotal study to evaluate the safety and efficacy of its RT001 investigational topical drug product candidate for the treatment of crow’s feet.
The Phase 3 trial will evaluate the safety and efficacy of a single, bilateral administration of RT001 topical gel compared to placebo in 450 patients with moderate to severe crow’s feet.
The company plans to release interim results from this Phase 3 study in the first half of 2016. Stay tuned.
First, Do No Harm
Neothetics Inc is evaluating the safety of its lipo-dissolving injectable LIPO-202 in obese individuals. The “belly-busting shot” is being developed for reduction to subcutaneous fat in non-obese subjects.
“While we are seeking approval of LIPO-202 for use in non-obese subjects, we recognize the importance of confirming safety in special populations. Consistently, our data has shown that LIPO-202 has a safety profile equivalent to placebo,” says Lincoln Krochmal, MD, chief medical officer for Neothetics, in a news release.
Neothetics expects to submit the results of the supplemental safety study to the US Food and Drug Administration as part of the company’s New Drug Application (NDA) package for LIPO-202, which the company anticipates filing in the second half of 2016. Stay tuned.
Freezing Out the Competition
Move over, Kybella. Zeltiq’s CoolSculpting now has the US Food and Drug Administration (FDA)’s nod to go after double chins and other small pockets of fat.
The new expanded clearance paves the way for the introduction of the CoolMini™ applicator. The new applicator’s size, shape, and curvature is designed to fit these small, problem areas. Patients may see results in as early as 3 weeks, with the most dramatic results generally observed 1 to 3 months following treatment.
The submental region has become a hot target in recent months. CoolSculpting’s new applicator joins the recently approved Kybella as well as many energy-based therapies aimed at the double chin. These minimally invasive methods now compete against traditional liposuction and face or neck lifting for market share.
Interested? Learn more now: http://bit.ly/1Mdl3nG