AEON Biopharma Receives Positive Outcome From FDA in Botox Biosimilar Meeting
AEON Biopharma, Inc. and U.S. Food and Drug Administration (FDA) are aligned on the regulatory pathway for ABP-450 (prabotulinumtoxinA) injection as a biosimilar utilizing BOTOX (onabotulinumtoxinA) as the reference product.
The Company is actively planning comparative analytical studies, which are expected to commence in Q4 2024. A Biosimilar Biological Product Development (BPD) Type 2 meeting with FDA is planned for 2025 to discuss the outcome from these studies and determine the next steps in development, including a potential comparative clinical program.
“We are encouraged by the outcome from the recent FDA meeting and the opportunity to advance our development of prabotulinumtoxinA utilizing the 351(k) biosimilar regulatory pathway,” says Marc Forth, AEON’s President and Chief Executive Officer, in a news release. “We now have a clear path forward and plan to initiate analytical studies in Q4 2024. This biosimilar approach could potentially allow us to bring prabotulinumtoxinA to the U.S. market for all of BOTOX’s currently approved and future therapeutic indications under a single approval.”
As previously announced, the Company expects it will need to conduct, subject to securing funding, a Phase 3 program to compare ABP-450 (prabotulinumtoxinA) with BOTOX (onabotulinumtoxinA) as the reference product. Under the 351(k) regulatory framework, comparative clinical studies are only required when it is necessary to address any residual uncertainty regarding biosimilarity following a comparative analytical assessment (CAA). The necessity of any specific comparative clinical studies will be determined after the FDA has reviewed the results from the CAA, which AEON currently anticipates in 2025.
Cynosure Lutronic Launches Mosaic 3D
Cynosure Lutronic is launching Mosaic 3D, a 1550 nanometer Erbium Glass non-ablative fractional resurfacing laser, while marking the sixth month anniversary of its merger.
The Mosaic 3D platform is designed to improve tone and textural concerns for patients by generating superficial and mid-dermal coagulation. Mosaic 3D is a versatile stand-alone platform that allows providers to customize patient treatments while managing patient comfort and minimizing down time with integrated air cooling.
The Mosaic 3D’s metal rollers and smart IntelliTrak system enable rapid, uniform skin coverage, while cold compression sapphire tips reduce superficial energy absorption, allowing for deeper coagulation zones. Mosaic 3D is also enabled by 3D Controlled Chaos Technology, an algorithm that controls the space and depth of each pulse, helping to maximize energy delivery while minimizing the risk of bulk heating.
“The versatility of Mosaic 3D allows the targeting of both superficial and mid-dermal depths, and it can also be safely paired with other energy-based treatments in a single session for synergistic outcomes. The integrated air-cooling system with sapphire stamping tip is an added convenience, making treatment sessions more comfortable for patients,” says Jordan V. Wang, MD, MBE, MBA, Medical Research Director at Laser & Skin Surgery Center of New York, and Medical Director at Laser & Skin Surgery Center of Pennsylvania, in a news release.
Six-Month Merger Update
Cynosure Lutronic has fully unified its teams across North America.
In addition to completing its integration in North America, Cynosure Lutronic held the inaugural Cynosure Lutronic Academy, in Las Vegas. The Academy brought together customers, practitioners, sales professionals, and industry experts to discuss the latest trends in aesthetic medicine, clinical best practices, and product innovation.
Hydrafacial Launches New Hydralock HA Booster
HydraFacial is rolling out its new HydraFacial Hydralock HA Booster.
The Hydralock HA Booster was developed to help combat dehydrated, dull, and stressed skin. It features a proprietary blend of triple hyaluronic acid xomplex, Vitamin B5, and fruit Extracts, which work together to deliver moisture and glow, while also helping to plump and firm the skin and reduce the appearance of fine lines and wrinkles.
After one Hydrafacial treatment with the Hydralock HA Booster, corneometer measurements of participants’ skin revealed:
- A 455% increase in hydration and 57% reduction in the appearance of wrinklesimmediately following the treatment.
- Sustained results, with a 338% increase in hydration1and 63% reduction in the appearance of wrinklesafter 24 hours.
Additionally, 94% of participants reported their skin remained more hydrated, moisturized and brighter 48 hours after the treatment.
“We are introducing the first booster in the Hydrafacial portfolio with clinical claims to address dry, dull, dehydrated skin and the signs of aging, which are top skin concerns our providers come across in their treatment rooms,” says BeautyHealth Chief Executive Officer Marla Beck, in a news release. “The Hydralock HA Booster further expands our range of over 15 boosters, helping our providers to offer highly customized Hydrafacial treatments that effectively address a variety of skin concerns.”
The Hydrafacial Hydralock HA Booster is available now globally.
Philosophy Unveils “Rated R” Campaign With Sarah Michelle Gellar to Challenge the Fear Surrounding Retinol in Skincare
Philosophy is teaming up with actress Sarah Michelle Gellar for its new campaign designed to demystify retinol use and the launch of its new Ultimate Miracle Worker Face & Neck Cream.
Inspired by Gellar’s legacy in horror films, the campaign includes a short film that plays on the association with fear to address the unnecessary trepidation many consumers feel about incorporating retinol into their skincare routines. The film will be shared across philosophy’s and Sarah Michelle Gellar’s social media channels, with further amplification by additional content creators who will stitch their own horror renditions to the campaign on social media.
To further amplify the campaign, philosophy is giving away 1,000 Rated R Fandango promotional codes redeemable for a movie ticket throughout October for free.
The campaign will premiere on October 1st across social media. To learn more, visit the campaign microsite https://airbaton.net/philosophy.
