TECLens and SERVImed Industrial Spa Announce a Partnership to Pursue U.S. FDA Approval for Trans-epithelial Corneal Cross-Linking
STAMFORD, Conn., Oct. 7, 2019,/PRNewswire/– TECLens, a medical device manufacturer and SERVimed Industrial Spa, an ophthalmic medical devices manufacturer and distributor today announced their partnership aimed at the development and FDA approval of a new combination product to treat keratoconus. The new product under development will combine TECLens’ CXLens® ‘on-eye’ cross-linking system for corneal remodeling with SERVImed’s trans-epithelial RIBOCROSS riboflavin drug formulation.
TECLens and SERVImed will pursue FDA approval for the combination product of CXLens® / RIBOCROSS to treat keratoconus that affects more than a million people in the US. Like Avedro, SERVImed’s RIBOCROSS holds an FDA orphan drug designation for its proprietary riboflavin formulation for the treatment of keratoconus in patients undergoing corneal cross-linking procedures.
“The combination of SERVImed’s proven RIBOCROSS and TECLens’ proven CXLens® will provide patients with a comfortable, non-invasive alternative to the treatment of ectatic disorders. Unlike any other cross-linking system, CXLens® can treat both eyes simultaneously. Our combination product with RIBOCROSS will significantly increase clinical efficiency and procedure margin for physicians practicing corneal cross-linking”, said TECLens CEO, David Acker.
“We are very excited about this partnership, and strongly convinced that the combination of TECLens’ technology and SERVImed’s expertise will provide patients and physicians with an innovative, more efficient and safer corneal cross-linking procedure”, said SERVImed CEO, Francesco Napolitano.
About TECLens (www.TECLens.com)
Based in Stamford, CT, TECLens is a clinical-stage medical device company developing an innovative, non-invasive corneal cross-linking procedure to treat keratoconus, low order myopia and eventually presbyopia. TECLens’ proprietary ‘on- eye’ CXL technology consists of a single-use disposable contact lens (CXLens®) and a small control system, which provide integrated real-time ultrasound feedback and patterned ultraviolet light delivery. TECLens believes on-eye cross-linking will become a safe, simple, and permanent alternative to LASIK, contact lenses, and eyeglasses for millions of people with vision errors.
About SERVImed Industrial Spa
Based in Rome, Italy, SERVImed Industrial is an R&D and manufacturing company focused on Ophthalmic Medical Devices. SERVImed’s portfolio includes patented solutions and devices for corneal cross-linking, eye drops and diagnostics. SERVImed’s patented cross-linking solutions are based on a unique formulation with riboflavin and vitamin E TPGS. They enhance corneal penetration while protecting the cornea, resulting in effective treatments, even in EPI-ON. SERVImed’s CXL solutions are currently used worldwide in different applications, including its own EPI-ON customized protocol with a 7-year published follow-up (Custom Fast CXL).