Avedro at vanguard of corneal cross-linking research, development

Cross-linking, alone and in conjunction with LASIK, promises to make inroads in the global market.

David F. Muller

Avedro, a global leader in corneal biomechanics research, is poised to assume a significant portion of the fledgling corneal cross-linking market, a company official said.

The company also expects to create a lucrative new global market niche with its KXL accelerated cross-linking system, designed to allow cross-linking to be seamlessly integrated into the standard LASIK procedure, David F. Muller, PhD, president and CEO of Avedro, said at the Ophthalmology Innovation Summit in Orlando, Fla.

Avedro has a wide sales and marketing presence built on research and innovation, Dr. Muller said.

“We’re fully commercialized around the world,” he said. “We’re in 41 countries. We have the next generation products that incorporate a lot of [intellectual property], a lot of new technology. There’s really nobody that’s competitive with us in this basic market.”

The company has 22 ophthalmic device distributors in 41 countries and is selling its cross-linking system in Canada, Mexico, South America, Europe, the Middle East, China, Japan, Australia and New Zealand, Dr. Muller said.

Avedro’s proprietary cross-linking system comprises VibeX, an ophthalmic riboflavin formulation, and the high-energy KXL device that generates UV light.

Avedro has completed a phase 3 multicenter clinical trial and plans to submit a new drug application to the U.S. Food and Drug Administration in the first quarter of 2012, Dr. Muller said.

The clinical trials included one group of patients with keratoconus and another group with corneal ectasia.

In the keratoconus trial, 102 patients underwent cross-linking and 103 patients served as controls. In the ectasia trial, 91 patients underwent cross-linking and 88 patients served as controls.

Both active groups of treated patients saw a statistically significant difference in mean change in maximum corneal curvature, as measure by K-max, from baseline to 12 months as compared with the control group (both P < .0001).

“In the FDA study, what we were able to show was that the cross-linking procedure actually stabilized the cornea and prevented it from getting worse,” Dr. Muller said.

Subsequent clinical trials are in the planning phase.

In addition, Avedro is collaborating with the American College of Ophthalmic Surgeons on an expanded clinical trial to be conducted at 100 sites in the U.S., Dr. Muller said.

“The benefit for us, obviously, is more data, more safety data and certainly an added patient benefit that goes along with it,” he said.

Avedro’s Lasik Xtra procedure incorporates cross-linking into standard LASIK surgery.

After excimer laser ablation of the flap bed, riboflavin is applied to the flap bed for 60 seconds. The riboflavin is flushed from the bed with balanced saline solution, and the flap is repositioned. UV light is then shone onto the cornea for 75 seconds.

“We know it restores strength to the cornea,” Dr. Muller said.

The Shinagawa LASIK Center in Japan expects to perform more than 2,000 Lasik Xtra procedures in 2012. The center generates $2,500 per bilateral LASIK case and an additional $2,000 for each bilateral Lasik Xtra procedure, Dr. Muller said.

Additionally, cross-linking alone can be used to correct myopia and astigmatism, Dr. Muller said.

“This has ramifications of not only expanding the market … but as an obvious adjunct to cataract surgery, where most patients need a little tune-up at the end,” he said. “We’ve demonstrated 3 D of myopia correction and 2 D of astigmatism correction, all with simply putting eye drops on the eye and a little light. So, that’s going to be attractive to patients.”

Lasik Xtra may generate up to $1 billion annually, and myopia correction may be a several billion dollars a year opportunity, Dr. Muller said. – by Matt Hasson

• David F. Muller, PhD, can be reached at Avedro, 230 Third Ave., Waltham, MA 02451; 781-768-3400; email: david@avedro.com.
• Disclosure: Dr. Muller is president and CEO of Avedro.