Sunrise Technologies International, Inc. (Fremont, CA) announced that senior Food and Drug Administration (FDA) officials informed the company that its Premarket Approval (PMA) application is tentatively scheduled for review at the July 22-23 meeting of the FDA. The panel will review the PMA for the Sunrise LTK System for the treatment of hyperopia (+.75 to +2.50 diopters).
The company stated that the FDA has asked for some minor reconfigurations of data tables that had previously been submitted in the company's PMA. Upon submission and confirmation of FDA's receipt of the data, which is expected later this month, the company anticipates review of the file at the July meeting of the Ophthalmic Devices Advisory Panel. The FDA usually posts its definitive schedule within 60 days of the panel meeting.
"We are enormously pleased to present our technology at the July Ophthalmic Devices Advisory Panel. We feel it is prudent to inform our shareholders at this time that it appears likely that our file will be reviewed in July. We believe that, if approved, the Sunrise LTK(TM) System has the potential to revolutionize how hyperopia is treated," said C. Russell Trenary III, Sunrise president and chief executive officer.
Sunrise, a refractive surgery company, believes that approximately 31% of Americans over 40 years old have hyperopia from +.75 to +2.50 diopters. The Sunrise office-based instrument is designed to treat hyperopia from +.75 to +2.50 diopters by applying two rings of laser energy to the mid-periphery of the cornea. Each ring 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 an instrument or any other apparatus. The Sunrise LTK procedure differs from excimer laser procedures (PRK and LASIK) and traditional incisional surgeries (Radial Keratotomy) because no corneal tissue is cut or removed.
The company announced last week that it has also received approval from the FDA to expand its U.S. clinical study for treatment of hyperopia from +2.75 to +4.0 diopters. The technique utilizes the same laser. For those patients, four rings of laser energy are applied to the mid-periphery of the cornea. The company estimates that the population of persons over 40 years old in the U.S. who have hyperopia up to four diopters represents 90% of all hyperopes in that age category.