Avedro Update: Company Completes U.S. Phase III Study of Microwave Treatment for Progressive Keratoconus and Ectasia after Refractive Surgery

I have been following the progress of Avedro since I first learned about the formation of the company back in May 2009 (The Rebirth of Thermal Keratoplasty). I then wrote about the company a second time in February 2010 (Avedro Keraflex: Microwaves for Reshaping the Cornea).

Now the company has announced completion of the one-year follow up visits of patients enrolled in its two multi-center Phase III clinical studies, although, not releasing the data as yet, which is undergoing timely analysis.

When the analysis is completed, I will bring you the results.

Multi-Center US Phase III Studies for the Treatment of Progressive Keratoconus and Ectasia Following Refractive Surgery

Avedro, Inc. announced the completion of all one-year follow-up visits for patients enrolled in its two multi-center Phase III studies evaluating the safety and efficacy of corneal collagen cross-linking for the treatment of progressive keratoconus and ectasia following refractive surgery.

Keratoconus is a degenerative disease of the eye and is the leading cause of corneal transplants in the US today. Ectasia following refractive surgery is a complication following various types of surgery, including LASIK. Outside the US, Cross-linking has been deemed safe and effective and is approved for use in treating keratoconus and ectasia post-refractive surgery.

For more information about both clinical trials please see:
for ecstasia - http://clinicaltrials.gov/ct2/show/NCT00674661
for progressive keratoconus - http://clinicaltrials.gov/ct2/show/NCT00647699

Dr. Peter Hersh, a leading refractive surgeon and Medical Monitor for Avedro's clinical trial stated, "Avedro's efforts to make this clinically important treatment available to US patients is applauded by all US ophthalmologists who today lack any approved therapeutic treatment to halt the progression of these sight threatening conditions."

"I am extremely pleased that we have reached this important stage in the US clinical trials and our team is working diligently to accomplish a timely analysis of data," said David Muller, CEO of Avedro. "Outside the US, cross-linking has become the standard of care for treating weak and ectactic corneas. It is our hope to bring this technology to the US in the near future."

The company is also the sponsor of another clinical trial using its Keraflex KXL technique, which  is expected to get underway in August 2011, Safety and Efficacy of the KXL System With Riboflavin 0.1% Ophthalmic Solution for Corneal Collagen Cross-Linking in Eyes With Keratoconus -  http://clinicaltrials.gov/ct2/show/NCT01344187
 

The purpose of this study is to compare the efficacy of two treatment regimens for corneal collagen cross-linking for the treatment of keratoconus. The treatment is designed to help improve or slow the progression of keratoconus. The study treatment involves using an eyedrop containing riboflavin, also known as vitamin B2. Riboflavin increases your eye's sensitivity to light. The riboflavin eyedrops are placed in your affected eye at two-minute intervals for 10 minutes and then your affected cornea is exposed to ultraviolet light (UVA) from the KXL System (the UV light machine) for another 2 or 3 minute period, depending upon which treatment group subjects are assigned to. Subjects will be followed for twelve months to evaluate the safety and efficacy of the treatment.