Avedro licenses Emory data on path to NDA submission

Waltham, MA-Avedro Inc. is licensing clinical trial data from Emory University, Atlanta, and combining it with data from its own multi-site clinical trials of corneal collagen crosslinking.

The agreement is an effort to “augment, support, and accelerate Avedro’s regulatory path for submission to the FDA” of a new drug application (NDA) for the treatment of keratoconus and post-LASIK ectasia, according to David Muller, PhD, president and chief executive officer of Avedro.

Both parties’ clinical trials are designed to assess the safety and efficacy of riboflavin and ultraviolet-A (UVA) light for halting the progression of keratoconus and post-LASIK ectasia and the accompanying decline in patient’s visual acuity from these two degenerative disorders.

“Keratoconus and post-LASIK ectasia are degenerative diseases [that], in the United States, lack any treatment option to halt their progression,” said J. Bradley Randleman, MD, associate professor of ophthalmology, section of cornea, external disease, and refractive surgery, at Emory University. “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. A positive determination would provide an important new treatment for patients suffering from these debilitating diseases.”

Corneal crosslinking combines the photosensitizer riboflavin with UVA light to increase corneal strength and stability by inducing new crosslinks between or within collagen fibers. In multiple international clinical trials, crosslinking has been shown to halt the progression of keratoconus and ectasia and to enhance the biomechanical stability of the cornea. Crosslinking is now approved for use internationally.

Avedro, a privately held medical device company, developed a non-invasive, incisionless refractive correction procedure (Keraflex KXL) from its thermobiomechanics and crosslinking platforms. The procedure is under clinical investigation in Europe for treating myopia and keratoconus.