Modulight Corp. has received an approval from the US Food and Drug Administration FDA for its ML6710i laser device for the treatment of wet age-related macular degeneration (AMD) in the United States, which was already expected in 2021 and discussed in the listing prospectus.
The company started cooperating with Bausch + Lomb on the preparation of a marketing authorization application for the US Food and Drug Administration FDA already in 2018. Now the company has received information about the approval. The company will start launching the product in the US without delay.
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. VISUDYNE® is an injectable photosensitizer for the treatment of patients with choroidal neovascularization due to age-related macular degeneration (AMD) or other causes. The VISUDYNE® drug is activated with Modulight 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.
Modulight has submitted the product's marketing authorization application also in the European Union, where the authorization is expected this year.