UK Keratoconus Self-Help and Support Association

From the NKCF September 2011 E-Update‏ (sorry, not obvious link to this from their website http://www.nkcf.org/en/newsletter.html ... I think you have to register to get it). Here's the text:

Corneal Crosslinking a Step Closer to FDA Approval

The U.S. Food and Drug Administration (FDA) has granted orphan-drug designation to Avedro, Inc. for VibeX (0.1% riboflavin ophthalmic solution) for use with its CXL System (UVA irradiation) for corneal crosslinking to treat keratoconus. Orphan-drug designation is granted by the FDA Office of Orphan Products Development to promote the development of new therapies for rare diseases and disorders affecting fewer than 200,000 individuals in the United States. Orphan-drug designation may entitle Avedro to seven years of U.S. marketing exclusivity upon regulatory approval.

“The orphan-drug status for riboflavin granted to Avedro from the FDA Office of Orphan Products Development is just a step in the approval of crosslinking for keratoconus. It is a specific designation of the drug, not actual FDA approval of the procedure. The results of the Phase III multicenter clinical trial of crosslinking for keratoconus are very encouraging and continue to be assessed, so progress is steadily continuing” said Dr. Peter Hersh, "This orphan-drug designation, along with the encouraging clinical results from our Phase III keratoconus study, is another important step in bringing this technology to patients in the US,” said David Muller, CEO of Avedro. “We look forward to working with FDA as we progress towards an NDA submission in the very near future.”

This will definitely help with any insurance claims for the procedure (but will still be a bit of a battle )

Cheers

Chris

Makes the point that in many jurisdictions this treatment is still considered 'experimental' and its results 'speculative'.

Andrew MacLean wrote:Makes the point that in many jurisdictions this treatment is still considered 'experimental' and its results 'speculative'.

Hi

Certainly a valid point, and people should be cautious. However, it was developed in Germany in 1993 with the first patients treated in 1998. Hundreds of patients have been treated in Germany, US and more recently the UK since then allowing experts to gather data (not just speculative) over the years. So far, the results collated over the past 13 years have been very promising. Debate also seems to be going on as to whether epi on or off is best. Again, only time will tell.

I'm one of those that decided to have it done in both eyes as my vision had reached the stage where I couldn't tolerate lenses, glasses were of abslutely no benefit, and the condition was progressing fairly rapidly only leaving a couple of options. I've also had a wedge resection/auto lamellar keratoplasty. Weighing things up (prospect of transplant), I figured it was worth the risk. As with any procedure, there has to be a starting point ('guineapigs').