Byooviz is an injection delivered into the vitreous humor of the eye (intravitreal) and is usually given once a month. It works by keeping new blood vessels from forming under the retina (a sensory membrane that lines the inside of the eye). In people with certain types of eye disorders, new blood vessels grow under the retina where they leak blood and fluid. 

Byooviz eye injection is used to treat several eye diseases and conditions, including neovascular (wet) age-related macular degeneration (nAMD), which a leading cause of vision loss and blindness for people aged 65 years and older. It is also approved to treat macular edema (fluid build-up) following blockage of veins in the retina (RVO) and myopic choroidal neovascularization (mCNV), a vision-threatening complication of nearsightedness. 

Byooviz (ranibizumab-nuna) is the first biosimilar to Lucentis (ranibizumab injection) that has been approved by the FDA.

You should not receive Byooviz if you are allergic to ranibizumab, or if you have any type of infection in or around your eyes.

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.

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.

For people with macular degeneration: After you have received the first 3 or 4 injections, your doctor may change your injection schedule to once every 3 months.

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.

Neovascular (Wet) Age-Related Macular Degeneration (AMD)
Byooviz 0.5 mg (0.05 mL of 10 mg/mL solution) is recommended 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. In the 9 months after three initial monthly doses, less frequent dosing with 4-5 doses on average is expected to maintain visual acuity while monthly dosing may be expected to result in an additional average 1-2 letter gain. Patients should be assessed regularly.
Although not as effective, patients may also be treated with one dose every 3 months after 4 monthly doses. Compared with continued monthly dosing, dosing every 3 months over the next 9 months will lead to an approximate 5-letter (1-line) loss of visual acuity benefit, on average. Patients should be assessed regularly.

Macular Edema Following Retinal Vein Occlusion (RVO)
Byooviz 0.5 mg (0.05 mL of 10 mg/mL solution) is recommended to be administered by intravitreal injection once a month (approximately 28 days).
In Studies RVO-1 and RVO-2, patients received monthly injections of ranibizumab for 6 months. In spite of being guided by optical coherence tomography and visual acuity re-treatment criteria, patients who were then not treated at Month 6 experienced on average, a loss of visual acuity at Month 7, whereas patients who were treated at Month 6 did not. Patients should be treated monthly.

Myopic Choroidal Neovascularization (mCNV)
Byooviz 0.5 mg (0.05 mL of 10 mg/mL solution) is recommended to be initially administered by intravitreal injection once a month (approximately 28 days) for up to 3 months. Patients may be retreated if needed.

What happens if I miss a dose?

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

What happens if I overdose?

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

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.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.
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.

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

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

Byooviz may cause serious side effects. 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.
• Common Byooviz side effects of 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.

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.

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.