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FDA Approves the First Eye-Specific Bevacizumab for Wet Macular Degeneration After Two Decades of Off-Label Use
['Dorothy Brooks']
Medical Daily
The FDA has approved the first ophthalmic formulation of bevacizumab for wet age-related macular degeneration, closing a gap that has defined retina care for twenty years.
For the roughly 1.5 million Americans living with wet AMD, the immediate clinical change is smaller than the announcement suggests.
In wet AMD, abnormal blood vessels grow beneath the retina and leak fluid and blood.
Sterility failures in compounded ophthalmic bevacizumab have caused clusters of endophthalmitis, a serious intraocular infection, on multiple occasions.
An approved ophthalmic product brings FDA-reviewed manufacturing, approved labeling written for intravitreal use, formal pharmacovigilance, and a defined quality system.