Advanced Medical Optics, Inc. (AMO) (NYSE:EYE), the global leader in advanced refractive technologies for eye care professionals and patients, today announced the U.S. Food and Drug Administration (FDA) has granted premarket approval (PMA) of Healon D® viscoelastic, a clear dispersive ophthalmic viscosurgical device (OVD) for use as a surgical aid in cataract extraction, intraocular lens (IOL) implantation, corneal transplant, and glaucoma filtration surgery.
Healon D® OVD’s formula provides exceptional clarity in the surgical field and a high degree of protection of corneal endothelial cells. Due to its low molecular weight, Healon D® OVD coats the cornea and remains in place throughout the entire surgical process. Its lower viscosity provides ideal lubrication of IOL insertion systems. Like all members of the Healon® family, Healon D® OVD is latex free, which means a safer environment for patients and physicians.
“Whether I will be using it exclusively, or in combination with other Healon® OVDs, Healon D® viscoelastic will help me deliver optimal clinical outcomes for my patients,” said Dr. Roger Steinert, director, cornea, refractive and cataract surgery, and vice chair, clinical ophthalmology at the University of California, Irvine. “The Healon® family of OVDs provides me with the complete range of viscosurgical tools I need during every step of cataract surgery.”
The FDA’s approval of Healon D® OVD allows AMO to introduce for the first time, two new dual-pack ophthalmic viscosurgical systems (OVS) featuring Healon D® and Healon GV® OVDs as well as Healon D® and standard Healon® OVDs in convenient combination packs.
Healon GV® viscoelastic is a cohesive OVD that provides exceptional control for the surgeon during ophthalmic surgery. It has the highest molecular weight of any OVD on the market and its high viscosity allows for increased anterior chamber expansion and maintenance.
AMO plans to ship Healon D® OVD and the new dual-packs in the fourth quarter.
About the Healon® Family of OVDs
Healon® products are the standard in reliability in OVDs and have been used in over 40 million eyes during the last 28 years. The Healon® family of OVDs provides endothelial cell protection, space maintenance, and chamber stability during surgery. Surgeons have a choice of Healon®, Healon GV®, Healon5® and Healon D® OVDs to provide the protection and control they need to complement their surgical techniques and preferences.
About Advanced Medical Optics (AMO)
AMO is focused on providing the full range of advanced refractive technologies and support to help eye care professionals deliver optimal vision and lifestyle experiences to patients of all ages. Products in the cataract line include monofocal intraocular lenses (IOLs), phacoemulsification systems, viscoelastics, and related products used in ocular surgery. AMO owns or has the rights to such product brands as Tecnis®, Clariflex® and Sensar® IOLs; Sovereign®, Sovereign® Compact and WhiteStar Signature™ phacoemulsification systems with WhiteStar® technology; Healon® viscoelastics and the Baerveldt® glaucoma shunt. Products in the refractive line include wavefront diagnostic devices, femtosecond lasers and associated patient interface devices; excimer laser vision correction systems and treatment cards, and refractive implants. AMO brands in the refractive business include iDesign™, iFS™, Star S4 IR®, WaveScan Wavefront®, Advanced CustomVue™, IntraLase®, IntraLasik® and ReZoom®, Tecnis® Multifocal and Verisyse® IOLs. Products in the eye care line include disinfecting solutions, enzymatic cleaners, lens rewetting drops and artificial tears. Among the eye care product brands the company possesses are COMPLETE®, COMPLETE® Blink-N-Clean®, Consept®F, Consept® 1 Step, Oxysept® 1 Step, UltraCare®, Ultrazyme®, Total Care™ and blink® branded products. AMO is based in Santa Ana, California, and employs approximately 4,000 worldwide. The company has operations in 30 countries and markets products in approximately 60 countries.
For more information, visit the company’s Website at amo-inc.
This press release contains forward-looking statements about AMO, including statements by Dr. Steinert and statements relating to expected product performance and anticipated outcomes, as well as expected shipment dates. All forward-looking statements in this press release represent AMO’s judgment only as of the date of this press release. Actual results may differ from current expectations based on a number of factors. Therefore, the reader is cautioned not to rely on these forward-looking statements. AMO disclaims any intent or obligation to update these forward-looking statements. Additional information concerning these and other risk factors may be found in previous press releases issued by AMO and AMO’s public periodic filings with the Securities and Exchange Commission, including the discussion under the heading “Risk Factors” in AMO’s 2007 Form 10-K filed in March 2008. Copies of press releases and additional information about AMO are available at amo-inc.