Modulight laser gets FDA approval for photodynamic AMD treatment
The company will start launching the product in the US without delay – European Union authorization is expected this year.
The US Food and Drug Administration (FDA) has approved the biomedical laser company’s ML6710i photodynamic laser for equivalent use with global eye health company Bausch + Lomb’s Visudyne (verteporfin for injection) photodynamic therapy (PDT) for the treatment of patients with predominantly classic subfoveal choroidal neovascularization, or the creation of abnormal choroidal blood vessels, due to age-related macular degeneration (AMD). ML6710i is expected to be available for eye care professionals during the first half of 2023.
The ML6710i is a new type of medical laser device designed to treat various eye diseases. It is very easy to use and works with the iPad. All operating parameters and laser usage events are securely stored in the Modulight Cloud treatment log.
In 2018, Bausch + Lomb, the world's leading company focusing on the treatment of eye diseases, and Modulight signed an exclusive cooperation agreement for the development of laser devices that work with the company’s Visudyne drug, an injectable photosensitizer which is activated with the ML6710i laser.
“Modulight works closely with healthcare companies to tailor its wide range of laser technology solutions to meet their needs in particular. Our collaboration with Bausch + Lomb has continued for several years, and together we have succeeded in developing a top-class laser. Now that we have received approval in the US market, we will be able to bring this product on sale,” commented Modulight’s CEO Seppo Orsila.
“PDT continues to be an important treatment option for eye care professionals who are looking to treat patients with predominantly classic subfoveal choroidal neovascularization,” said Christina Ackermann, president, ophthalmic pharmaceuticals, Bausch + Lomb. “With the approval of ML6710i, eye care professionals now have a new state-of-the-art photodynamic laser that addresses a significant unmet need in PDT and is specifically designed to deliver Visudyne to patients who suffer from wet AMD with persistent fluid.”
Modulight has submitted the product’s marketing authorization application also in the European Union, where the authorization is expected this year.
