STAA receives CE Mark approval for Visian Implantable Collamer Lens V4 design

Apr 25 2011

STAAR Surgical Company (NASDAQ: STAA), the leading developer, manufacturer and marketer of minimally invasive ophthalmic lenses for refractive surgery, today announced CE Mark approval for its Visian® Implantable Collamer® Lens (ICL™) V4c design.  The V4c design incorporates a proprietary port in the center of the ICL optic of a size determined to optimize the flow of fluid within the eye, and eliminates the need for the surgeon to perform a YAG peripheral iridotomy procedure days before the ICL implant.  The result is more comfort for the patient and a more convenient, efficient ICL experience for both the patient and the surgeon.  Both myopic and myopic toric models of the ICL will feature the new design.  The Company has two issued patents on the technology to enhance flow within the eye and is pursuing additional claims to further broaden its intellectual property position.

The clinical research on the technology was performed by Dr. Kimiya Shimizu, Professor and Chair of the Department of Ophthalmology at the Kitasato University in Tokyo, Japan.  Dr. Shimizu performed the first phase of the trials in 2008 when he implanted six patients with the current ICL in one eye and the new V4c design in the second eye.  Iridotomies were performed in the eyes with the current ICL, but not in the fellow eyes with the new V4c design.  Dr. Shimizu completed the second phase of the study in 2010 when he followed the same clinical protocol with 19 additional patients.  The clinical results showed that eyes with the V4c design had the same intraocular pressure (IOP) post operatively as the fellow eyes with the current ICL model.  Dr. Shimizu also evaluated other key outcomes including: visual acuity, contrast sensitivity, stability of refraction, predictability of outcomes and visual disturbances which proved to provide the same excellent results documented with the Visian ICL technology.  Dr. Shimizu has continued to use the technology in additional patients since completing his study.

"We appreciate very much the clinical work and advice of Dr. Shimizu and other leading Visian ICL surgeons, who were instrumental in bringing this very significant improvement to the market," said STAAR Surgical CEO Barry G.  Caldwell.  "This technology marks another key advancement from our product pipeline of planned new features designed to provide continuous enhancements to the Visian ICL technology.  Late last year we launched the V4b ICL model in CE Mark countries, which expanded the range of approved treatment zones on the myopic, hyperopic and Toric models of the ICL.  This added range of treatment has already resulted in increased usage of the product in those markets."

"We are off to a good start in 2011 with strong sales of the ICL products outside the U.S.," continued Mr. Caldwell.  "This CE Mark approval positions us to build further on this momentum this year.  In addition, the V5 model is currently underway with our Research and Development team and the concept designs for the V6 model are in the feasibility phase.  I would also like to thank and congratulate our R&D and Regulatory teams, which worked together to bring the V4c technology to market earlier than originally anticipated."

The V4c model has been approved in the -0.5 diopter to -18.0 diopters myopic range and +0.5 cylinder power to +6.0 for the Toric ICL models.  The Company plans to first engage a pre-market release of the product in four sites and 100 eyes before a full launch to the markets that accept CE Mark Approvals.  In some of the key Asia Pacific markets that have not yet launched the V4b model, the Company plans to seek approval of the V4c and move directly to this new model.

SOURCE STAAR Surgical Company