FDA Approves First LED System for Treatment of Acne.

Business Editors

IRVINE, Calif.--(BUSINESS WIRE)--June 25, 2003

Alderm LLC and it's exclusive manufacturing partner Photo Therapeutics Limited of Manchester, U.K. have received marketing clearance from the U.S. Food and Drug Administration (FDA) for the OmniLux Blue Light Emitting Diode (LED) system used in the treatment of dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris.

According to James Kraushaar, president of Alderm, this marketing clearance represents "a breakthrough in terms of making this highly-efficacious and cost-effective LED technology available to medical dermatologists as an alternative treatment for acne which has no serious negative side effects. Once acne patients become aware of this new treatment, systemic drugs will certainly become less desirable options."

Omnilux Blue utilizes a panel of LEDs, encased within one of several interchangeable heads, driven by the OmniLux core technology platform. These LEDs deliver narrowband 415 nm visible light with high spectral purity, meaning that no UV, IR or inappropriate visible radiation is delivered. This increases both the precision and effectiveness of the treatment.

This system provides a non-invasive and non-thermal treatment targeting P. acnes, the causative organisms of inflammatory acne, and promoting natural cellular response and tissue regeneration. In addition to the singlet oxygen mechanism for effecting bacterial cell death, light absorption by target cells also induces changes in membrane permeability leading to proton influx and dissipation of pH gradients across the cell membrane. The combination of these resultant factors restores the correct homeostatic state to the pilosebaceous unit, resulting in the formation of a microenvironment unsuitable for P. acnes.

Omnilux Blue clinical studies conducted to GCP/ICH standards have been completed. Results at 12 and 16 weeks show a reduction in inflammatory lesion counts (papules and pustules) across the entire study group of greater than 70%, with over 86% of the group showing an average reduction of 74%. Over 90% of all subjects recorded treatment satisfaction as very good or excellent.

Alderm, the exclusive distributor of Photo Therapeutics light devices in the U.S., has well-established relationships with numerous leading clinical research sites for ongoing studies with OmniLux Blue. In addition, OmniLux Revive, designed for skin treatments using red light, is pending FDA clearance.

Founded in 1998, Photo Therapeutics is a well-funded, private company based in the U.K., with distribution partners throughout the world. Co-founded by one of the largest cancer research institutions in the world, this company manufactures a unique line of LED devices (OmniLux and Revive) which are specifically designed for photodynamic therapy (PDT) skin cancer treatment, general dermatology and cosmetic applications.