Byooviz

Byoovizis a prescription eye injection is used to treat types of macular degeneration, macular edema and myopic choroidal neovascularization. Byooviz is vascular endothelial growth factor (VEGF) inhibitor that works by keeping new blood vessels from forming under the retina (a sensory membrane that lines the inside of the eye). Byooviz (ranibizumab-nuna) is from the class of medicines called anti-angiogenic ophthalmic medications.

Byooviz is an injection delivered into the vitreous humor of the eye (intravitreal) and is usually given once a month.

Byooviz is an interchangeable biosimilar to Lucentis (ranibizumab injection) that was originally approved by the FDA on September 20, 2021, and became an interchangeable medicine on October 3, 2023.

Byooviz is FDA approved to treat:

• neovascular (wet) age-related macular degeneration (nAMD) a leading cause of vision loss and blindness for people aged 65 years and older
• macular edema following retinal vein occlusion (RVO), this is fluid build-up due to blockage of veins in the retina.
• myopic choroidal neovascularization (mCNV), a vision-threatening complication of nearsightedness.

Byooviz is given as an injection into your eye.

Your doctor will use a medicine to numb your eye before giving you the injection.

You will receive this injection in your doctor's office or other clinic setting.

For a short time after your injection, your eyes will be checked periodically to make sure the injection has not caused any side effects.

Byooviz is usually given once every month.

Length of treatment and dosing schedules depend on the condition being treated.

Follow your doctor's dosing instructions very carefully. The timing of your monthly injections is very important for this medication to be effective.

To be sure Byooviz is helping your condition and is not causing harmful effects, your eyes will need to be checked on a regular basis. Do not miss any follow-up visits to your doctor.

Call your doctor at once if you have sudden vision problems, eye pain or redness, or if your eyes are more sensitive to light.

The timing of your monthly injections is very important for this medication to be effective.

You should not receive Byooviz if you are allergic to ranibizumab or if you have any type of infection in or around your eyes. To make sure this medicine is safe for you, tell your doctor if you have ever had:

• glaucoma; or
• a history of blood clots or stroke.

Pregnancy

It is not known if Byooviz will harm an unborn baby, but it may pose a risk to fetal development and fertility. Tell your doctor if you are pregnant or plan to become pregnant.

Breastfeeding

It is not known whether Byooviz passes into breast milk or if it could affect the nursing baby. Tell your doctor if you are breast-feeding.

Common Byooviz side effects may include:

• eye pain or irritation;
• feeling like something is in your eye;
• itchy or watery eyes;
• dry eyes, puffy eyelids;
• blurred vision;
• sinus pain, sore throat, cough; or
• nausea.

Byooviz may cause serious side effects.

Get emergency medical help if you have signs of an allergic reaction to Byooviz including hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• eye pain or redness, swelling around your eyes;
• blurred vision, tunnel vision, eye pain, or seeing halos around lights;
• increased sensitivity to light;
• discharge or bleeding from the eye;
• seeing flashes of light or "floaters" in your vision;
• sudden numbness or weakness (especially on one side of the body); or
• sudden severe headache, problems with speech or balance.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Usual Byooviz dosing information

Neovascular (Wet) Age-Related Macular Degeneration (AMD): 0.5 mg by intravitreal injection once a month (approximately 28 days). Comment:

• 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.

Macular Edema Following Retinal Vein Occlusion (RVO): 0.5 mg by intravitreal injection once a month (approximately 28 days).

Myopic Choroidal Neovascularization (mCNV): 0.5 mg by intravitreal injection initially once a month (approximately 28 days) for up to 3 months. Patients may be retreated if needed.

Call your doctor for instructions if you miss an appointment to receive your ranibizumab injection.

Since this medicine is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

Other drugs may interact with ranibizumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

This medication may cause blurred vision. Be careful if you drive or do anything that requires you to be able to see clearly.

• This medicine should be refrigerated at 2°C to 8°C (36°F to 46°F). DO NOT FREEZE.
• Protect vials from light and store in the original carton until time of use.
• Do not use beyond the date stamped on the label.

Active ingredient: ranibizumab-nuna

Inactive ingredients: histidine monohydrochloride, histadine, trehalose dihydrate, polysorbate 20, water.

Manufactured by:

Samsung Bioepis Co., Ltd., 76, Songdogyoyuk-ro, Yeonsu-gu, Incheon, 21987, Republic of Korea.

Manufactured for:

Biogen Inc., 225 Binney Street, Cambridge, MA, 02142.

Biosimilar and interchangeable products are biological products that are highly similar to and have no clinically meaningful differences from the reference product.

Reference products

These are biological products that have already been approved by the FDA, against which biosimilar products are compared. There are 2 for Byooviz.

Lucentis (ranibizumab) - Genentech, Inc.

View Lucentis information in detail.

Susvimo (ranibizumab) - Genentech, Inc.

View Susvimo information in detail.

Lucentis interchangeable products

Interchangeable biosimilar products can be dispensed by a pharmacist without the intervention of the prescriber of the reference product.

Pharmacy laws for biosimilar prescribing may vary by state.

Byooviz (ranibizumab-nuna) - Samsung Bioepis Co., Ltd.

Cimerli (ranibizumab-eqrn) - Sandoz Inc.

View Cimerli information in detail.

Nufymco (ranibizumab-leyk) - Zydus Lifesciences Global FZE

View Nufymco information in detail.