Medical Device Daily

Ophthalmic product maker Staar Surgical (Monrovia, California) said earlier this week that federal regulators are unlikely to approve its new implantable lens this year as the company had hoped.

After meeting with FDA officials last week to discuss its premarket approval (PMA) supplement, Staar learned that its Visian TICL (toric implantable collamer lens) would have to be reviewed by the Ophthalmic Devices Panel of the Center for Devices and Radiological Health because the device is the first toric phakic implantable lens to be reviewed.

The Visian TICL is designed to treat myopia and astigmatism. The company submitted the application last May (Medical Device Daily, May 4, 2006) as a supplement to the PMA application for its Myopic Visian ICL, which the FDA approved in December 2005 (MDD, Dec. 29, 2005) for the correction of myopia in adults.

Larry Haimovitch, president of Haimovitch Medical Technology Consultants (Mill Valley, California) told Medical Device Daily the delay is a setback for Staar because the TICL is a "unique product with killer data."

"The clinical results for the toric ICL are nothing short of spectacular . . . I'm blown away [by the data]," Haimovitch said. "It's a great product, it should be on the market and I think it'll do well once it gets approved."

David Bailey, president/CEO of Staar, said it is "highly unusual for a supplemental application to be submitted to the Panel for review," but acknowledged that "the TICL is a first-of-its-kind device and we look forward to providing all necessary support to substantiate its safety and effectiveness."

"We had hoped for faster review, but based on this feedback we believe that approval of the TICL will be unlikely in 2007, as previously anticipated," Bailey added.

The Visian TICL — which is already on the market in Europe and some Asian countries for the correction of astigmatism — is a refractive phakic implant intended for placement in the posterior chamber of the eye. Astigmatism, which is usually caused by uneven curvature of the surface of the eye, causes light rays to focus at different points inside the eye. A person with astigmatism will experience blurriness in part of the visual field in both near and distance vision. The supplemental filing supports an indication for the correction of myopia and astigmatism in adults with myopia ranging from -3.0 to less than or equal to -20.0 diopters with astigmatism ranging from 1 diopter to 4 diopters at the spectacle plane, with anterior chamber depth (ACD) 3.00 mm or greater, and a stable refractive history within 0.5 diopters for one year prior to implantation.

The device was approved in China last August (MDD, August 7, 2006). Soon after receiving approval there, Professor Yuangui Wang performed the first two bilateral surgeries on Aug. 9 at the WJ Army Hospital (Shenzhen, China). The first patient was a nearsighted 35-year-old male journalist with astigmatism, and the second was a severely nearsighted 19-year-old female student, also suffering from astigmatism. Staar said both had "significantly improved vision" after the procedure. The company also reported that after the Visian ICL was implanted, the first patient could see 20/15 with both eyes and the second patient improved to 20/20 the following day.

Made of Staar's highly biocompatible Collamer material, the ICL is the only minimally invasive foldable lens of its kind approved for the Chinese commercial market. As a result of the foldable design, the ICL procedure allows an incision up to 50% smaller than competing technology, Staar said, adding that its placement in the eye behind the iris "provides a more aesthetically pleasing outcome," (MDD, August 23, 2006).

Staar Surgical makes minimally invasive ophthalmic products, which include its Visian ICL, a tiny, flexible lens implanted to correct refractive errors, as well as products designed to improve patient outcomes for cataracts and glaucoma.