The FDA has given its approval for Advanced Medical Optics' (AMO) Tecnis foldable acrylic intraocular lens (IOL) for reduced spherical aberration and improved functional vision in cataract patients.
Success for foldable acrylic IOL
Offering the same benefits as the Tecnis silicone IOL, in a simulated night driving study, patients viewing a rural road through the Tecnis lens identified hazards significantly sooner than through a traditional spherical IOL, providing a 45-foot advantage in detection and identification distance.
Tecnis foldable IOLs are indicated for primary implantation for the visual correction of aphakia in adults in whom a cataractous lens has been removed by phacoemulsification.
The Tecnis foldable acrylic IOL is being rolled out in the US and Europe from September 2005.
Another FDA approval for AMO
Clinical studies demonstrated, at six months, patients receiving the CustomVue high myopia treatment were corrected to 20/40 or better and 84.3% were corrected to 20/20 or better, without the aid of spectacles or contact lenses.
CustomVue procedures for high myopia are now being rolled out across the US to certified VISX Technology doctors, following completion of training and certification process.
Macugen heads for Europe
Already approved for use in the US, Canada and Brazil for the same indication, an authorization decision regarding the marketing of Macugen across Europe is expected at the end of the year.
Macugen is the first and only approved ophthalmic medication which targets and inhibits vascular endothelial growth factor, a key mediator of choroidal neovascularization in AMD.
Eyetech has granted exclusive marketing rights to Pfizer for commercialization of the agent outside of the US.
Refocus Group gains FDA approval to proceed with final phase trials for its Scleral Spacing Procedure in presbyopia
The FDA has granted approval to the Dallas-based Refocus Group to initiate enrolment into the final clinical trial stages for the company's Scleral Spacing Procedure (SSP), based on positive data presented from Phase II surgeries earlier in 2005.