Cutera's AviClear Scores FDA Nod as Long-Term Acne Treatment

Cutera’s AviClear initially received FDA clearance for treating acne in March 2022.

The U.S. Food and Drug Administration (FDA) has cleared AviClear as a long-term treatment for mild to severe inflammatory acne vulgaris. 

Cutera’s AviClear initially received FDA clearance for treating acne in March 2022. Now, the FDA has cleared the device  for the long-term treatment of acne. This is the first acne therapy to claim long term effectiveness for mild, moderate and severe acne, the Company states.

“It is incredibly impressive that AviClear is now the first and only acne therapy, of any kind, able to claim long term effectiveness for mild to severe acne,” Michael H. Gold, MD, Medical Director, Gold Skin Care Center, tells DermWire. “There is nothing else on the market, not drug or laser, that can make that claim. This is huge for patients who are considering all of the treatments on the market, because they can have confidence that treatment with AviClear will also them long-term clearance.”

The first 1726nm laser to be introduced to the market, AviClear selectively targets and suppresses the sebaceous glands, eliminating acne at the source, offering a durable and prescription free option for patients and providers. In three, 30-minute treatment sessions 90% of patients experienced visible improvement in their acne six months after their third session. According to 12-month clinical data, improvement increases to 92%, confirming long-term efficacy of acne clearance and skin quality over time.

“Those of us who have been using AviClear on our patients since the initial FDA Clearance recognized that the results of the treatment get progressively better with time,” says Emmy M. Graber, MD, MBA, the Founder of The Dermatology Institute of Boston, in a news release. “I am thrilled that the FDA has now acknowledged these long-lasting results, giving both patients and dermatology providers greater confidence in the efficacy and durability of AviClear results.”

“We are proud to receive such a significant and landmark designation. The success of AviClear is a testament to Cutera’s ingenuity and innovation as a pioneering force in results-driven technology,” adds Sheila A. Hopkins, Interim CEO at Cutera. “Throughout Cutera’s 25-year history, we have continued to develop devices that offer physicians and their patients breakthrough treatment options, and AviClear is a great example of our game changing technologies.”