Sun Pharmaceutical Industries Ltd has announced that it has received approval from the US Food and Drug Administration (USFDA) for a next-generation medical device designed to treat actinic keratoses (AK), a skin condition often caused by prolonged sun exposure. According to the US National Center for Biotechnology Information (NCBI), actinic keratosis typically appears as red, scaly patches or plaques on sun-exposed areas such as the face, scalp, or arms, and can potentially progress to skin cancer if left untreated.
The newly approved device is an upgraded version of the BLU-U Blue Light Photodynamic Therapy (PDT) system and marks a significant advancement in the treatment of AK. Unlike its predecessor, which used fluorescent tubes to emit blue light, the updated model incorporates LED technology. This upgrade not only enhances the treatment's precision and reliability but also allows for a more compact and user-friendly design.
The treatment involves using the device in combination with LEVULAN® KERASTICK®, a topical solution containing aminolevulinic acid. When applied to affected areas, this substance helps target and eliminate minimally to moderately thick actinic keratoses lesions.
Sun Pharma emphasized that the FDA’s approval was granted through its Real-Time Review Program, highlighting the quality of the company’s submission and the strength of its collaboration with the regulatory agency.
Abhay Gandhi, CEO of Sun Pharma (North America), expressed confidence in the new product’s impact. “We are pleased to receive FDA approval for the LED BLU-U system. This innovation underscores our ongoing commitment to advancing patient care in dermatology,” he said. “We believe the new LED-based model will enhance treatment efficiency and provide consistent, reliable results while maintaining the safety standards healthcare professionals and patients expect from Sun Pharma.”