Combining clinical trial data for corneal collagen cross linking to accelerate FDA process
September 22, 2010
Avedro and Emery University have entered into an agreement to combine clinical trial data for corneal collagen cross-linking.
Avedro and Emery University have entered into an agreement to combine clinical trial data for corneal collagen cross-linking. The organisations’ are both looking a the safety and efficacy of riboflavin and ultraviolet-A light for halting the progression of keratoconus and post-LASIK ectasia and the associated deterioration in patient’s decline as a result of these disorders.
Dr Peter Hersh, professor of ophthalmology at UMDNJ – New Jersey Medical School and director of Cornea and Laser Eye Institute – CLEI Centre for keratoconus said: The primary goal of collagen crosslinking is to strengthen and stiffen the corneal fibers in order to decrease the progression of keratoconus and post LASIK ectasia and to decrease the cone steepness in some patients. The safety ad efficacy of crosslinking, as demonstrated in the Avedro clinical studies is very encouraging.
Dr J. Bradley Randelman, Associate Professor of Ophthalmology Section of Cornea, External Disease and Refractive Surgery at Emory University stated: Our aim, in permitting Avedro to combine our clinical study results with its own, is to help Avedro expedite its NDA submission to the FDA. The more quickly the FDA can begin to review the results of this promising technology, the more quickly it can make a determination as to its safety and efficacy.