Evolved by Nature secures FDA clearance for atopic dermatitis treatment
The clearance marks the first time a product using a peptide from Evolved By Nature’s platform has completed the regulatory process required to reach patients in a regulated medical field.
USA – Evolved By Nature has announced the first FDA 510(k) clearance for a prescription therapy built on its programmable peptide platform.
The cleared product, New Day™ Skin Spray, is a topical emulsion spray for the management of dryness and atopic dermatitis, and is being developed and commercialized by Evolved Health, Inc.
New Day Skin Spray is now being introduced by prescription in select markets, with wider availability expected to follow. Evolved Health is commercializing the product in partnership with speciality pharmacy PHILRx.
Atopic dermatitis is associated with a weakened skin barrier, which can allow irritants, allergens and microbes to penetrate the skin and contribute to inflammation.
According to the company, the spray’s soluble silk fibroin peptide forms a flexible, breathable surface architecture after application.
This peptide matrix is intended to reinforce compromised skin and reduce the penetration of irritants and pathogens, including Staphylococcus aureus, a bacterium associated with more severe atopic dermatitis.
By reducing these external triggers, the product is intended to help interrupt the cycle that sustains flares. Evolved By Nature describes the therapy as a non-steroidal prescription option with no systemic exposure.
The technology behind the product is based on Evolved By Nature’s Activated Silk® biotechnology, which uses silk protein as the starting material for creating programmable peptide molecules.
According to the company, its proprietary NoviCulture process bioharvests peptides from silk cocoons, converts them into patented molecules and enables their design for specific performance requirements.
The platform is intended to produce peptide libraries that can be combined with other ingredients for applications across healthcare, biologics, personal care and other industries.
Evolved By Nature has developed the platform over more than a decade and currently manufactures it at a scale of 900 metric tons annually.
The initial launch remains limited to select markets, and the company has not disclosed details of a broader commercial rollout in the announcement.
The longer-term significance will depend on patient uptake, prescribing behavior, clinical-market evidence and the ability of Evolved By Nature and its partners to apply the platform to additional regulated therapies.
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