BYOOVIZ (ranibizumab-nuna) for Treatment of Retina

BYOOVIZ is a VEGF or vascular endothelial growth factor inhibitor and is indicated for the treatment of patients with:

• Neovascular (Wet) Age-Related Macular Degeneration (AMD)

• Macular Edema Following Retinal Vein Occlusion (RVO)

• Myopic Choroidal Neovascularization (mCNV)

• If you have ocular or periocular infections

• If you have hypersensitivity reactions to BYOOVIZ or any of the ingredients present in this medicine

• If you are pregnant or planning to become pregnant.

• If you are breastfeeding or planning to breastfeed.

For ophthalmic intravitreal (in the eyes) injection only

• BYOOVIZ 0.5 mg (0.05 mL) is the recommended dosage to be administered 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.

• BYOOVIZ 0.5 mg (0.05 mL) is the recommended dosage to be administered by intravitreal injection once a month (approximately 28 days).

BYOOVIZ 0.5 mg (0.05 mL) is the recommended dosage to be initially administered by intravitreal injection once a month (approximately 28 days) for up to three months. Patients may be retreated if needed.

The most common side effects are eye pain, vitreous floaters, conjunctival hemorrhage, and increased IOP.

• Endophthalmitis and retinal detachments: Endophthalmitis and retinal detachments may occur following intravitreal injections. Patients should be monitored following the injection.

• Increases in intraocular pressure (IOP): increases in intraocular pressure (IOP) have been noted in both pre-and post-intravitreal injection.

• Arterial thromboembolic events: there is a potential risk of arterial thromboembolic events following the intravitreal use of VEGF inhibitors.