Regeneron's BLA for fusion protein
March 9th 2011We may know within 6 to 10 months the results of the FDA?s review of Regeneron Pharmaceuticals? biologics license application (BLA) related to a fusion protein (VEGF Trap-Eye) for the treatment of neovascular age-related macular degeneration (AMD). If the review is favorable, use of the fusion protein ultimately could mean fewer injections per year for patients being treated for the disease.
ISTA asks FDA to prohibit generic BID bromfenac
March 9th 2011ISTA Pharmaceuticals has asked the FDA not to give tentative or final approval of any abbreviated new drug application for bromfenac sodium ophthalmic solution 0.09% that uses the labeling for the company?s discontinued twice-daily brand (Xibrom) or omits any portion of the label for its once-daily brand (Bromday) relating to the once-daily dosing.
Data positive for dual-optic lens
March 1st 2011While U.S. ophthalmologists continue to await FDA approval of the dual-optic accommodating IOL, accumulating data from a number of investigations are providing evidence about the long-term performance of this novel presbyopia-correcting implant technology.
Wavefront-guided, Wavefront-optimized LASIK: How much HOA?
March 1st 2011In young patients who present with low-to-moderate myopia, minimal astigmatism, and excellent optics, there is no doubt that wavefront-guided LASIK with femtosecond laser flap creation is the refractive surgery procedure of choice.