See all news

STAAR Surgical Receives Conditional Approval to Initiate Clinical Investigation in the U.S. on the Toric Implantable Contact Lens (TICL(TM))

  • 2002-01-10
  • Press release
MONROVIA, Calif., Jan 10, 2002 /PRNewswire via COMTEX/ --

Only phakic lens able to reduce pre-existing astigmatism and provide patients with visual correction for myopia (nearsightedness)

STAAR Surgical Company (Nasdaq: STAA) announced today that the United States Food and Drug Administration has issued conditional approval for an investigational device exemption (IDE) for the Toric Implantable Contact Lens (TICL). The IDE allows the Company to begin clinical investigation on the TICL in the United States with patients having myopia in the range of -3.0 to -20.0 diopters and astigmatism in the range of 1.0 to 4.0 diopters.

The TICL is the only phakic intraocular lens able to both reduce pre- existing astigmatism and provide patients with visual correction for myopia. According to industry sources, approximately 20 percent of the population suffer from astigmatism, a corneal irregularity causing impairment of sight, with the percentage much higher among severe myopic patients, the TICL target market.

Stephen G. Slade, M.D., FACS, in private practice in Houston, Texas, National Medical Director for TLC Laser Eye Centers and clinical investigator for the TICL FDA trial said, "Until now, phakic IOL technology has been limited to spherical correction. The addition of the astigmatic component provides an opportunity for complete vision correction to a population of patients who would otherwise have no option." Slade concluded, "The clinical investigation will represent a milestone in technology as phakic implants take us beyond the limits of laser correction."

David Bailey, STAAR's CEO and President, views the conditional approval as an important step in exploiting phakic implant technology to provide patients with the best possible vision correction. "When I arrived at STAAR a year ago I knew we had the best phakic implant technology in the industry. I made it a personal priority to bring these products to market as quickly as possible. The FDA conditional approval to begin investigation of the TICL is a significant step toward this goal. I am personally delighted with this approval."

Bailey added, "Since announcing our intention to move forward with this IDE we have had multiple requests from major refractive surgeons to become involved in the study. As a result we are confident of rapid enrollment of the 125 patients needed to complete the trial."

Enrollment in the primary FDA clinical trial for the ICL for myopia has been completed. The study demonstrates excellent visual outcomes with low complication rates to date. In a cohort of 529 cases the incidence of lens opacities was reported to be 2.3% (12 eyes), with 8 of these opacities being non-progressive and showing no loss of best-corrected visual acuity.

Founded in 1982, STAAR Surgical Company develops, manufactures and globally distributes medical devices for use in refractive, cataract and glaucoma surgery. The Company's five product lines include silicone and Collamer(TM) foldable intraocular lenses and the Sonic WAVE(TM) phacoemulsification system, all of which are used during cataract surgery, the ICL(TM) (implantable contact lens) which is a refractive lens for the treatment of near- and far-sightedness and the AquaFlow(TM) Collagen Glaucoma Drainage Device. Regulatory approvals vary from market to market with all products except the Toric ICL(TM) and the 3-piece Collamer(TM) IOL available in Europe and all except the ICL(TM) in the United States.

For additional information, about STAAR Surgical, visit the Company's web site at or . You may wish to contact David Bailey, President, STAAR Surgical, or John Bily, Chief Financial Officer, STAAR Surgical, at (626) 303-7902. To contact Bill Roberts, President, CTC, Inc., or Wayne Buckhout, CTC Inc., please call (937) 434-2700.

                     MAKE YOUR OPINION COUNT - Click Here
SOURCE STAAR Surgical Company

CONTACT:          David Bailey, President, or John Bily, Chief Financial Officer,
                  of STAAR Surgical, +1-626-303-7902; or Bill Roberts, President, or Wayne
                  Buckhout of CTC Inc., +1-937-434-2700

Copyright (C) 2002 PR Newswire.  All rights reserved.