Avedro Announces Completion of 1st US Phase III Corneal Cross-linking Clinical Trials

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

WALTHAM, Mass.--(BUSINESS WIRE)--Avedro, Inc. today 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.

“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.”

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, a surgical procedure for correcting myopia (short sightedness) and hyperopia (far sightedness). Outside the US, Cross-linking has been deemed safe and effective and is approved for use in treating keratoconus and ectasia post-refractive surgery.

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.”

About Avedro, Inc.

Avedro, a privately held ophthalmic device and drug company based in Waltham, MA, developed the KXL System for performing Accelerated Cross-linking and Lasik Xtra. Avedro has also developed the Vedera System for performing Keraflex, a non‐invasive, incision‐less ophthalmic procedure for flattening the cornea. Because Keraflex thermally remodels the cornea without the removal of any tissue, the procedure offers the unique ability to induce refractive change without weakening the cornea’s biomechanical integrity, as happens with LASIK and other refractive correction procedures. Both devices and procedures are CE marked and commercially available outside of the United States.