Ophthalmic medical devices maker Avedro touted the launch of 2 new studies examining its light-based cross-linking, evaluating the therapy in treatment of patients post-Lasik surgery and patients with keratoconus, a degenerative eye disorder.
The Massachusetts company hopes to use the findings to support pursuit of regulatory approvals in the U.S. for Lasik with cross-linking, or Lasik Xtra, and for pulsed UVA light in treatment of keratoconus.
The Lasik Xtra study will examine cross-linking as a complement to Lasik surgery, evaluating whether cross-linking helps prevent refractive outcomes, improving vision in patients with hyperopia or hyperopic astigmatism, according to a company statement. The therapy is already available on the global market and has been used in treatment of more than 75,000 patients already, Avedro reported.
The ‘Pulsed Accelerated Cross-linking’ study will evaluate specialized UVA light therapy in treatment of keratoconus, a condition in which the front surface of the eye thins and begins deforming into a cone-like shape, causing blurred vision and light-sensitivity.
Both studies have already enrolled their 1st patients, Avedro said.
Cross-linking is a procedure that pairs ultraviolet light with riboflavin eye drops. The eye drops are placed on the cornea and exposed to the UV light , which spurs a molecular bond between collagen molecules. Avedro’s KXL Accelerated Cross-Linking system, that latest generation of which just won approval in the European Union, promises to perform the procedure "in minutes," rather than the hour-long operation usually performed.