FDA Approves First Biosimilar to Treat Macular Degeneration Disease and Other Eye Conditions The U.S. Food and Drug Administration today approved Byooviz (ranibizumab-nuna) as the first biosimilar to Lucentis (ranibizumab injection) for the treatment of several eye diseases and conditions, including neovascular (wet) age-related macular degeneration (nAMD), a leading cause of vision loss and blindness for Americans aged 65 years and older. Byooviz is also approved to treat macular edema (fluid build-up) following retinal vein occlusion (blockage of veins in the retina) and myopic choroidal neovascularization, a vision-threatening complication of myopia (nearsightedness). Biological products are generally derived from a living organism and can come from many sources, including animals and microorganisms, such as bacteria or yeast. A biosimilar is a biological product that is approved based on data showing that it is highly similar to a biological product already approved by the FDA (reference product) and has no clinically meaningful differences in terms of safety, purity and potency (i.e., safety and effectiveness) from the reference product, in addition to meeting other criteria specified by law. Patients can expect the same safety and effectiveness from the biosimilar over the course of treatment as from the reference product. Byooviz is administered by intravitreal injection (delivered into the vitreous humor of the eye) once a month. Administration of Byooviz may cause serious side effects, including: endophthalmitis (infection inside the eye) and retinal detachments; increases in intraocular (inside the eye) pressure; and thromboembolic (obstruction of a blood vessel by a blood clot) events. The most common side effects of Byooviz include conjunctival hemorrhage (broken blood vessel), eye pain, vitreous floaters (black spots that drift across the eye) and increased intraocular fluid pressure. | 
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