Safilens Secures FDA Approval for Deseyne Daily Contact Lenses
Key Insights
Safilens (search) has received FDA approval to market its fusion 1day daily contact lenses, branded as Deseyne (search), in the United States.
The approval marks a significant milestone for Safilens (search), making it the first Italian company in the sector to register its material, Vifilcon C, in the U.S.
Bruno Vision Care LCC (search), the American subsidiary, managed the classification and approval process, which spanned over six years.
Safilens (search) 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 (search).
The FDA approval marks a significant achievement for Safilens (search), 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 (search), the American subsidiary of Safilens.
"This is a crucial achievement, especially for a manufacturer like Safilens (search) 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 (search). This milestone makes Safilens the first Italian company in the sector to register its own material in the U.S.