Corneal Cross-linking gets second orphan drug status approval

By Jen Weigel on December 08, 2011

Dr. Holzman is gearing up to bring corneal cross-linking to Tysons Corner soon.  He will be one of the principal investigators in a clinical study for corneal cross-linking which means that we will be able to help patients with keratoconus or post-refractive surgery ectasia all over the Maryland - DC - Virginia region. 

"The use of UV-A irradiation combined with topical Riboflavin to increase collagen cross-linking (CXL) has shown great potential over this past decade in slowing or eliminating progression of keratoconus and post-LASIK ectasia," Dr. Holzman said.  Prior to cross-linking, we were pretty much limited to glasses, contacts, or a corneal transplant, but now we have a powerful treatment option for patients with these unique conditions.

In September 2011, a company called Avedro received FDA orphan drug status for its cross-linking system for the treatment of keratoconus.  Yesterday, it received a second orphan drug status for its same system for the treatment of post-refractive surgery ectasia. 

Basically, orphan drug status allows a company to develop drugs that are meant for a small target audience.  Often times with these specialized medications, the amount of effort for research and development is far greater than the potential profit margin.  In return for developing a medication or procedure that can help a small - but important - population, the FDA assists the company by offering certain incentives or tax breaks to make their investment more worthwhile.  On the flip side, when a company seeks to develop a medication that will help a ton of people (ex: a new cholesterol-lowering medication), the FDA does not provide orphan drug status assistance because future profits will more than make up for the initial research and development.

With so many positive changes in the development of this treatment option, cross-linking is sure to have a positive impact on the lives of many patients keratoconus or ectasia patients in the Maryland - DC - Virginia region.  We plan on beginning the enrollment process over the next few weeks.  If you have been diagnosed with keratoconus or have been deemed a non-candidate for LASIK or PRK because you were a keratoconus suspect, please contact our office at 703-556-9155 or send our Clinical Director an email at jen (dot) weigel (at) so that you can be added to our growing list of potential candidates.  - jw

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