FDA Approves Byooviz (ranibizumab) for Neovascular AMD, Macular Edema Following RVO, and Myopic CNV

Byooviz is a vascular endothelial growth factor (VEGF) inhibitor.

BYOOVIZ is indicated for the treatment of patients with: Neovascular (Wet) Age-Related Macular Degeneration (AMD), Macular Edema Following Retinal Vein Occlusion (RVO), and Myopic Choroidal Neovascularization (mCNV).

For ophthalmic intravitreal injection only. The recommended dose is 0.5 mg (0.05 mL of a 10 mg/mL solution). For Neovascular (Wet) AMD: Administer by intravitreal injection once a month (approximately 28 days). Although not as effective, patients may be treated with 3 monthly doses followed by less frequent dosing with regular assessment. Although not as effective, patients may also be treated with one dose every 3 months after 4 monthly doses. Patients should be assessed regularly. For Macular Edema Following RVO: Administer by intravitreal injection once a month (approximately 28 days). The label states patients should be treated monthly, noting that in referenced studies, patients not treated at Month 6 after initial therapy experienced an average loss of visual acuity at Month 7. For Myopic Choroidal Neovascularization (mCNV): Initially administer by intravitreal injection once a month (approximately 28 days) for up to three months. Patients may be retreated if needed. Preparation requires specific, non-included medical devices: a 5-micron sterile filter needle (18-gauge × 1-1/2 inch or 19-gauge × 1-1/2 inch), a 1-mL Luer lock syringe, and a sterile 30-gauge × ½ inch injection needle. Administration must be carried out under controlled aseptic conditions.

Trial data not available in label. The label references Clinical Studies sections 14.1, 14.2, and 14.3 but does not provide the specific efficacy or safety data from those trials within the provided text.

Not reported in label.

Not reported in label.