Ondine Biopharma, a developer of photodisinfection-based products, has filed a premarket approval (PMA) submission with the FDA, seeking approval for marketing of the Periowave Photodisinfection System in the US. The system is intended for the treatment of chronic periodontitis in adults as an adjunct to standard methods of care.
Periowave is a non-antibiotic photodisinfection system developed by Ondine that utilizes a low-intensity diode laser and a wavelength-specific, light-activated photosensitive compound, which when used in conjunction with standard methods of dental care, reduces the symptoms of chronic periodontitis.
The photosensitizing solution is topically applied to the treatment site and preferentially stains pathogenic microbes present at the site.
Once activated by the Periowave laser, the sensitizer destroys the pathogens as well as pathogen-associated virulence factors, significantly improving clinical outcomes. The photodisinfection process is designed to avoid the development of antibiotic resistance.
The photodynamic disinfection technologies were developed by Professor Michael Wilson and colleagues at the Eastman Dental Institute, University College London.
Periowave is currently approved in Canada and the European Union for the treatment of a number of gum diseases, including periodontitis, peri-implantitis, and peri-mucositis. In June of 2009, Ondine sold its dental healthcare business to Periowave Dental Technologies (PDT).
Under the terms of the sale, the company is entitled to receive royalties and milestone payments based on sales of the Periowave Photodisinfection System by PDT, Ondine continues to be the manufacturer of the product and is responsible for obtaining regulatory clearance for marketing of the product in the US.