Biosimilar approved for the treatment of macular degeneration and other eye conditions

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The FDA has recently approved the first biosimilar for the treatment of neovascular (wet) age-related macular degeneration as well as other eye diseases and conditions.

Byooviz (ranibizumab-nuna), an intravitreal monthly injection biosimilar, can also be used in the treatment of macular edema after retinal vein occlusion and myopic choroidal neovascularization.

A recent press release from the FDA stated that approval was based on data review that included, “extensive structural and functional characterization, comparative clinical efficacy and safety evaluations, including potential immunogenicity that demonstrated Byooviz is biosimilar to Lucentis.”

Potential side effects caused by Byooviz include:

• Endophthalmitis
• Retinal detachments
• Increased intraocular pressure
• Thromboembolic events
• Conjunctival hemorrhage
• Eye pain
• Vitreous floaters
• Increased intraocular fluid pressure

According to Ankur Dave, Compliance Officer at SpecialtyRx, “Byooviz is one of over thirty FDA approved biosimilars. SpecialtyRx is keeping a close watch on these and other FDA approved treatments so that we can provide our clients with the best and broadest options available.”