Cross-linking undergoing intense study in U.S.
CHICAGO — Corneal collagen cross-linking, although not approved by the U.S. Food and Drug Administration, is undergoing rigorous study on several fronts, according to a speaker here.
“Since this was first presented virtually 2 decades ago, cross-linking has certainly become an accepted modality worldwide for the treatment of keratoconus,” Peter S. Hersh, MD, said during a keynote lecture at the Refractive Surgery Subspecialty Day preceding the American Academy of Ophthalmology meeting. “We as ophthalmologists and patients in the U.S. are looking forward to approval and complete adoption of this important treatment option.”
From its inception to the present day, cross-linking (CXL) has evolved from a simple ultraviolet light source into a more sophisticated surgical platform involving the manipulation of corneal biomechanics, according to Hersh.
“CXL in the U.S. is not FDA-approved. However, numerous procedures have been done and are being done under formal clinical trial protocols at over 100 clinical practices throughout the U.S.,” Hersh said.
Ongoing studies are looking at new ultraviolet light sources, new riboflavin formulations, trans-epithelial techniques, combined CXL/laser refractive techniques and topography-guided methods, according to Hersh.
For example, a multicenter, placebo-controlled clinical trial was launched in 2008 with a focus on keratoconus and keraectasia; 293 eyes had kertoconus and 219 eyes had ectasia.
Additionally, Avedro submitted a new drug application to the FDA for CXL in September. The company is sponsoring two multicenter studies in the U.S. with a total of 452 eyes.
A U.S. clinical trial on CXL combined with LASIK (LASIK Extra) for high myopia is also scheduled for launch in early 2015, Hersh said.
“Hopefully, this will shed a lot of light on the safety and efficacy of the LASIK Extra procedure,” he said.
There are also 10 independent physician studies that are ongoing, according to Hersh.Disclosure: Hersh is a consultant for Avedro and Synergeyes.