FDA Approval for Same Day SecondEye Treatment for Sunrise Technologies LTK Mid-hyperopia Study --+2.75 to +4.0 Diopters
July 13, 1999 07:04 AM
FREMONT, Calif.--(BW HealthWire)--July 13, 1999--Sunrise Technologies International, Inc. SNRS announced that it has received conditional approval from the U.S. Food and Drug Administration (FDA) to treat, in its ongoing U.S. clinical trials, the second eye on the same day as the first eye using the Sunrise laser thermal keratoplasty (LTK) treatment for mid-hyperopia from +2.75 to +4.0 diopters.
The approval allows for treatment of the second eye of the current subjects as well as treatment of both eyes of future subjects on the same day. On May 4, Sunrise announced it had received approval from the FDA to expand its study for the treatment of mid-hyperopia. The study was expanded to 80 patients at up to six clinical investigation sites in the United States. Twenty patients at two sites have already been treated under a study that began in April 1998. Sunrise LTK surgeons and patients reported that they were eager to have immediate treatment of the second eye after receiving initial treatment.
The Company estimates that the ability to treat up to 4 diopters of hyperopia represents nearly 90% of all hyperopes over the age of 40.
The technique for treating mid-hyperopia utilizes the same laser as that which is used in the Company's initial study for treatment of hyperopia from +.75 to +2.5 diopters. Two rings of sixteen spots of laser energy are applied to the mid periphery of the cornea at the six and seven millimeter zones. Similarly, the technique for the study for lower levels of hyperopia (+.75 to +2.5 diopters) undergoing PMA review applies two rings of eight spots of laser energy at the six millimeter and seven millimeter zones at the mid periphery of the cornea. Each ring of eight spots of energy is applied in 1.4 seconds and gently heats collagen in the cornea to change corneal shape. The application of energy is accomplished without physically contacting the cornea with instrumentation or any other apparatus. The patient sits upright opposite the ophthalmic surgeon and the total chair time, including focusing, is designed to be less than five minutes.
The conditional approval means that the FDA has requested the Company submit additional information to the agency within 15 days which the Company has agreed to do.
Founded in 1987, the Company produces and markets high technology products revolutionizing treatment methods in eye care. The Company develops Holmium laser-based systems, which utilize a patented process for shrinking collagen developed by Dr. Bruce Sand (the "Sand Process") in correcting ophthalmic conditions. These Systems(a) incorporate a non-contact simultaneous application for correction of hyperopia (farsightedness), presbyopia (loss of focus due to natural aging), and overcorrection resulting from PRK and LASIK treatments for myopia. The system is currently in use in Europe and the Americas, and is in clinical trials in the United States.
Except for historical information, this news release contains certain forward-looking statements that involve risk and uncertainties which may cause actual results to differ materially from the statements made, including market potential, regulatory clearances, business growth, and other risks listed from time to time in the Company's Securities and Exchange Commission (SEC) filings. These forward-looking statements represent the Company's judgement, as of the date of this release, and the Company disclaims any intent or obligation to update these forward-looking statements.
(a) Caution-Investigational Device: Federal law restricts this device to investigational use in the U.S.
Internet users can access Sunrise's World Wide Web site at sunrise-tech.com.
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