Safety and efficacy of photosensitizer Photolon (Fotolon) in photodynamic therapy

Photosensitizer Photolon, a complex of chlorin e6 and PVP, was originally developed by RUE “Belmedprepa, and registered in Belarus, Russian Federation, Kazakhstan and Ukraine. During the last 18 years Photolon was used clinically and proven to be effective in photodynamic diagnostics and treatment of different cancerous and benign conditions. Pre–marketing clinical trials of Photolon were conducted at 4 major oncology centers in Minsk, Obninsk, and Moscow and total of 112 patients were included. Open-label randomized non-comparative clinical trial confirmed safety and efficiency of PDT with Photolon for 154 patients with CIN grade I-III. Clinical trial of PDT with Photolon was carried out in 68 patients with disseminated skin melanoma. Clinical trial was conducted in 37 patients with central lung carcinoma. In 2006 we started an open-label randomized controlled clinical trial of Photolon applied intraoperatively in patients with primary and metastatic brain tumors, 102 patients were treated. In 2006 an open-label multicenter clinical trial of Photolon for treatment of choroidal neovascularization (CN) in age-related macular degeneration and myopic maculopathy was complete. 50 patients with CN were treated and positive therapeutic effect was maintained in 100% of patients within 1 year. Since 2001 more then 35 000 doses of Photolon were produced, and about 20 000 patients were treated. During this time there were no reports of adverse events or failed treatment with Photolon. Photolon was proven to be an extremely effective photosensitizer for PTD for multiple medical conditions and has minimal side effects.