Safilens has announced that it has received approval from the Food and Drug Administration (FDA) to sell its fusion 1day family of daily contact lenses in the United States. These hydrogel lenses will be marketed under the brand name Deseyne.
The FDA approval marks a significant achievement for Safilens, particularly as an Italian company in a market dominated by multinational corporations. The approval process, which took over six years, was managed by Bruno Vision Care LCC, the American subsidiary of Safilens.
"This is a crucial achievement, especially for a manufacturer like Safilens that must be considered a minor player when compared to the giant multinationals active in this industry," remarked Daniele Bazzocchi, Safilens general manager.
The approved material, Vifilcon C (known as Filcon IV in Europe), is a new hydrogel material developed by Safilens. This milestone makes Safilens the first Italian company in the sector to register its own material in the U.S.
