Excerpt From Ocular Surgery News - August 2005

Ocular Surgery News
August 1, 2005; Vol. 23, No. 15, Page 50.

Colored artificial iris implants show promise in clinical trials

Natural-looking iris implants may soon be available to patients with iridic defects or damage. The implants have been successful in recent clinical trials, surgeons say.

by Daniele Cruz, OSN Staff Writer

With congenital iris defects occurring infrequently, artificial iris implants may not be a lucrative investment for an ophthalmic company, but the impact they have on a patient’s quality of life can be priceless, said Francis W. Price, Jr., MD.

Dr. Price is director of the Cornea Research Foundation of America and lead researcher for Ophtec USA, a company that is conducting phase 3 U.S. Food and Drug Administration trials for its artificial iris implant. He estimates that he has performed 55 surgeries with the artificial implants for adults and children.

“It’s not like there are thousands of people out there who need this,” he said. “But the people who need, need it really bad.”

Primarily, the implants are used for trauma cases that also involve the central cornea, he said, but there are patients with congenital defects that could also benefit from iris implants.

“If you ever go to see a movie matinee and come out into the sunlight, that is the way these people are all the time,” Dr. Price said. “They can’t go outside without discomfort. With the implants, there is still some light sensitivity, but they make it a whole lot better.”

In a study by Scott E. Burk, MD, PhD, and colleagues, published in the November 2001 issue of the Journal of Cataract and Refractive Surgery, 25 patients were enrolled in an interventional prospective noncomparative case series to determine the efficacy and safety of prosthetic iris implants in patients with anatomic or functional deficiencies.

The study concluded that implantation of prosthetic iris devices improved postoperative outcomes by reducing glare disability in addition to correcting aphakia in some cases.

Seeking FDA Approval

The Ophtec FDA study began about 3 years ago with the model 311, a single-piece lens with 13.5-mm haptics that are sewn into the sclera. The lens has a central 4-mm opening, but the rest of the lens is opaque in brown, green or blue colors.

“It helps make people look normal and do a lot more things that they couldn’t do before,” Dr. Price said. “We’re really thankful that the FDA allowed us to carry this study out. It is hard for the company to justify the expense to get approval, but the people that need them, need them desperately.”

In the best-case scenario, the company will receive FDA approval for the colored iris implants within 2 years, Dr. Price said.

Ophtec President Rick McCarley said the company is performing clinical trials at 12 sites throughout the United States with up to 300 patients. He said the FDA study is the only clinical study currently under way for this type of product in the United States.

“This lens has been successfully used in Europe for over 15 years to treat patients on a custom basis, but no prospective clinical study was ever conducted. Based on the overwhelmingly positive outcomes from these cases, we decided to perform confirmatory studies in the United States to register the product,” Mr. McCarley said.

The purpose of the lens is to reduce the amount of undesirable, visually disturbing light entering the eye so that the patient can enjoy a more normal life. Restoring the iris color to the eye is secondary.

He added that the efficacy of the device depends on the condition of the eye.

“The lenses are all custom-made devices, even in Europe. Each is made on a patient-by-patient basis,” he said.

The implants are made of UV-blocking PMMA along with bound color pigments. They are surgically placed behind the iris in the ciliary sulcus. If the patient already has an IOL in place, the iris implants are available with no power.

“This is not just a standard FDA clinical investigation for an IOL,” Mr. McCarley said. “We also have to contend with a unique additional element, and that is an FDA color additive petition.”

Adding a material for the sole purpose of coloring a device involves an additional regulatory body within the FDA to oversee the approval process.

“Everyone looks at everyone’s eyes. These aren’t perfect, but they’re really good. People have just been tremendously happy with them,” Dr. Price said. “They go home and take the patch off because they want to see what makes a big difference for them.”

Patient Population

Currently, the Ophtec implants are available to patients in the U.S. FDA study or through an individual FDA compassionate use exemption, Mr. McCarley said.

“Because the causes of aniridia or serious iris damage are so diverse, this is an extremely unique population of patients,” he said. “Almost no two are the same.”

“We have used it for cosmetic uses in blind eyes,” Mr. McCarley said. “But the primary indication for the lens and purpose of the study is related to reducing or eliminating the visual disturbances caused by total or partial iris damage.”

Although he has successfully implanted artificial irises in children, Dr. Price said there is a limiting factor for young people.

“You don’t want to do this procedure on them unless they have a cataract or had a cataract removed,” he said. “Because, where the lens is going it’s going to cause a cataract. We just don’t do them unless they’ve had a cataract removed. We’re not doing this for cosmetic reasons. We want to make sure we’re making people better.” OSN

For Your Information

Francis W. Price, Jr., MD can be reached at 9002 N. Meridian Street, Suite 100, Indianapolis, IN 46260; tel: 317-844-5530; fax: 317-844-5590. Dr. Price has no financial interest in the products mentioned in this article, nor is he a paid consultant for any companies mentioned.

Rick McCarley, president and chief executive officer of Ophtec USA Inc., can be reached at 6421 Congress Ave., Suite 112, Boca Raton, FL 33487; tel: 561-989-8767; fax: 561-989-9744.

Reference: Burke SE, Da Mata AP, et al. Prosthetic iris implantation for congenital, traumatic, or functional iris deficiencies. J Cataract Refract Surg. 2001; 27:1732-1740.

Daniele Cruz is an OSN Staff Writer who covers all aspects of ophthalmology. This article includes reporting by OSN Staff Writer Jared Schultz.