Safilens, Italian leader in contact lenses, has landed on its feet overseas.

SAFILENS INNOVATION and TECHNOLOGY launch in the US with the DESEYNE BRAND

Safilens, Italian leader in contact lenses, has landed on its feet overseas.

After several years, the fusion 1day family of daily contact lenses has received approval from the FDA (Food and Drug Administration) – the United States federal agency responsible for regulating food and drug products – for sale in the US market. The daily lenses will be sold under the Deseyne brand.

“We are very proud of this achievement, achieved with perseverance and self-sacrifice. We would like to thank the American authorities and especially the Food and Drug Administration, which thoroughly evaluated our products and decided to approve them, firmly convinced of their technical and scientific value.  We are aware, however, that this is only the first step in a long adventure in the United States, the world’s leading contact lens market, which will require further dedication and maximum focus. “ Vincenzo Bruno – Sole Director Safilens.

The particularly complex classification and approval process, which lasted more than 6 years, was conducted by the American subsidiary Bruno Vision Care LCC and was further impacted by delays due to the pandemic.

The most burdensome aspects were the need to register with the US authorities a new hydrogel material, Vifilcon C (in Europe Filcon IV), developed by Safilens for its outstanding characteristics of comfort and perfect compatibility with the patented release technology, and the use of natural polysaccharides like TSP and hyaluronic acid, such as Lachryceuticals®, that the lenses release onto the eye during wear. All of the innovative features in these daily enriched hydrogel lenses required even closer examination and clinical evaluation by the US agency. Safilens is thus the first Italian company in the sector to have its own material registered in the US.

“This is a crucial achievement, especially for a manufacturer like Safilens that, while representing excellence in innovation in the contact lens market, must be considered a minor player when compared to the giant multinationals active in this industry. The American scenario opens new, exciting prospects. We must do our best to take advantage of this opportunity,” remarked Daniele Bazzocchi, Safilens General Manager.

“We are redefining this category with a new generation of contact lenses. I am forever grateful for the world-class experts in Optometry and Regulatory Compliance who helped our company shepherd this life-changing technology through the US regulatory process. It’s a once-in-a-generation opportunity to improve lives, and we remain dedicated to bringing it to the US market and beyond.” Eddie Catalfamo, CEO Bruno Vision Care LCC.

In the next few months, the Deseyne Daily Disposable product family for the American market will be completed with the addition of all the EDOF geometries for presbyopia and asthenopia.