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TDD Industry News and Views: Weekly Updates on Comings, Goings, and Other Happenings in Dermatology in the U.S. and Abroad

PCA SKIN Rolls Out Two New Professional Acne Peels 

PCA SKIN is introducing the Acne Peel and Acne Peel Plus.

Both professional peels can help treat all severities of acne, from mild to severe, and inflamed to non-inflamed conditions.

Acne Peel: A professional peel that exfoliates, unclogs pores, helps balance oil and treats mild persistent breakouts. Ideal for mild acne and congested skin. Clinically proven to deliver a 40 percent reduction in whiteheads and a 36% decrease in breakouts based on a 12-week case study after three peeling sessions.

Acne Peel Plus: A professional peel specifically designed for moderate to severe acne, helping to improve active acne and future occurrence in just one session. Ideal for moderate to severe, inflamed acne. Acne Peel Plus is clinically proven to decrease the appearance of pustules by 28% and papules by 48% based on a 12-week case study.

Ewelina Lesniak, Director of Skin Health Production Development, CP Skin Health Group. “Alongside a powerful combination of AHA/BHA, we have incorporated an ingredient, often referred to as a third-generation retinoid, which has been shown to target microcomedones in the skin to help prevent and reduce breakouts,” says Ewelina Lesniak, Director of Skin Health Production Development, CP Skin Health Group, in a news release.

Obagi Introduces Two New Elastiderm Products

Obagi Medical is launching Elastiderm Lift Up & Sculpt Facial Moisturizer and Elastiderm  Advanced Filler Concentrate.

The Elastiderm  Lift Up & Sculpt Facial Moisturizer comprises Obagi’s patented Bi-Mineral Contour Complex, which combines zinc, copper, and malonate to help support skin elasticity and target the signs of skin aging. It incorporates Polyglutamic Acid (PGA), a peptide known for its hydrating properties

The non-injectable Elastiderm Advanced Filler Concentrate is formulated with Acetyl Hexapeptide-1, to smooth wrinkles and add volume.

“These formulations enhance overall skin texture, underscoring our commitment to integrating cutting-edge scientific research and ingredients into practical, effective skincare solutions,” says Eman Kadhim, Head of Scientific Communications & Upstream Innovation at Waldencast, in a news release.

 

Daxxify Approved in China

The National Medical Products Administration has accepted the Biologics License Application (“BLA”) for Sisram Medical’s Daxxify for the temporary improvement in the appearance of moderate to severe glabellar lines caused by movements associated with corrugator and/or procures muscle activity in adult patients. The toxin is made with and Revances’s proprietary Peptide Exchange Technology (PXT).

Alongside a license agreement granting exclusive rights to import, sell, and commercialize Daxxify in Mainland China, Hong Kong SAR, and Macao SAR, the Company’s injectables portfolio includes partnerships with IBSA for the dermal biostimulator Profhilo in other APAC markets, and with Prollenium for its dermal filler collection, approved Revanesse brand fillers, in several markets including Germany, Austria, Switzerland, Australia, New Zealand, and Japan, with potential expansion into other regions.

“China has always been a strategic market for Sisram, and the approval of Daxxify serves as a key milestone for bringing Sisram’s high-end injectables portfolio to Mainland China,” says Mr. Liu Yi, Sisram Chairman and Executive Director, in a news release. “From a business perspective, this achievement enhances the competitiveness of the Company’s products, expanding its diversified offerings and delivering an innovative experience for beauty-seeking patients.”

 FDA Grants Orphan Drug Designation for AISA-021 for Systemic Sclerosis

The U.S. Food and Drug Administration (FDA) has granted orphan drug designation to Aisa Pharma, Inc.’s AISA-021(cilnidipine), a fourth-generation calcium channel antagonist under development for the treatment of Systemic Sclerosis (SSc).

“To our knowledge, this is the first time the FDA has granted orphan drug designation to a calcium channel antagonist for an autoimmune illness,” saysAndrew Sternlicht, MD, CEO and Founder of Aisa Pharma, in a news release. “We hope this designation will accelerate our development program for AISA-021, which is designed to provide a once-daily, well-tolerated, and economical treatment that we hope can improve the lives of patients with SSc. We are actively seeking a development partner and investors to support bringing this much-needed treatment to patients.”

Aisa submitted information from the ongoing Phase 2 study demonstrating improvement on several endpoints versus placebo, including SSc symptoms of overall disease severity, disease-related pain, gastrointestinal dysfunction, skin ulcers, disability, and breathing symptoms, as well as Raynaud’s symptoms. In a preliminary review by an independent data safety committee, the ongoing study of 60 patients demonstrated a much lower incidence and severity of side effects as well as improved efficacy for preventing Raynaud’s attacks, when compared to published reviews of current therapies.

The company also noted that a Pre- investigational new drug (IND)  meeting with the FDA for AISA-021 in the treatment of Systemic Sclerosis and Secondary Raynaud’s Phenomenon is scheduled for September 2024.