Byooviz™ (ranibizumab-nuna) is the first biosimilar eye drug approved by the US Food and Drug Administration (FDA). Byooviz is approved to treat:1-3
- Neovascular (wet) age-related macular degeneration (nAMD)
- Macular edema after retinal vein occlusion (RVO)
- Myopic choroidal neovascularization (mCNV, a complication of myopia that can cause vision loss)
Byooviz is a biosimilar to Lucentis® (ranibizumab). Lucentis is one of the most commonly prescribed drugs for age-related macular degeneration (AMD).
In the United States, anywhere from 2 to 11 million adults have AMD. Vision loss and blindness can occur in people with untreated wet AMD.1-3
Lucentis is a biologic. Biologics are drugs made from living cells. These cells can come from parts of the blood, proteins, virus, or tissue. The process of making biologics turns these cells into drugs that can prevent, treat, and cure disease. Drugs similar in structure to known biologic drugs are called biosimilars. Biosimilars must undergo clinical trials and approval by the FDA before doctors are able to prescribe them.
What are the ingredients in Byooviz?
The active ingredient in Byooviz is ranibizumab-nuna. It is a biosimilar drug to Lucentis.1-3
How does Byooviz work?
Byooviz is a type of drug known as an anti-VEGF. It is given as an injection into the eye by a retina specialist. Anti-VEGF drugs help improve or stabilize vision by reducing the number of leaking, abnormal blood vessels within and underneath the retina. The retina is the light sensing structure in the back of the eye.4
Vascular endothelial growth factor (VEGF) is a protein our bodies make to promote the growth of new blood vessels. However, some people with macular degeneration make too much VEGF. This causes abnormal blood vessels to grow in the eye. These blood vessels can cause damage, leak, or may even bleed, which can affect your vision, causing low vision or blindness.4
Byooviz blocks VEGF, which slows down blood vessel growth in the eye. This can slow or stop damage and vision loss. It may also improve vision in some cases.4
What are the possible side effects of Byooviz?
The most common side effects of Byooviz include:1-3
- Broken blood vessels on the surface of the eye
- Eye pain
- Temporary drifting black spots or floaters in the eye
- Increased fluid pressure of the eye (intraocular pressure)
Less common but serious side effects may include:1-3
- Infection inside the eye
- Retinal detachment
- Blood clots that increase the risk of stroke or heart attack
These are not all the possible side effects of Byooviz. Talk to your doctor about what to expect when receiving Byooviz. You also should call your doctor if you have vision loss or any other changes that concern you when taking Byooviz.
Things to know about Byooviz
Byooviz is not right for everyone. People with an infection in or around the eye should not use Byooviz. People who are allergic to Byooviz or any of its ingredients should not use this drug.3
Byooviz is injected into the eye once a month. Your doctor will monitor your intraocular pressure before and after your Byooviz injection.3
Eye injections carry a small risk of retinal detachment. If you notice new flashing lights, increasing new floaters (more than those noticed immediately after injection), or a shadow/dark curtain coming over your vision from any direction, you should notify your eye doctor immediately.
Retinal detachment is a medical emergency where the retina pulls away from the tissue that supports it.
Eye injections also carry a small risk of infection inside the eye. This is also a medical emergency. If an infection occurs, it is more likely to happen in the first 7 days after the injection. If your eye becomes red or painful, or you become sensitive to light or notice vision changes, notify your eye doctor right away.3
Before beginning treatment for macular degeneration, tell your doctor about all your health conditions and any other drugs, vitamins, or supplements you are taking. This includes over-the-counter drugs.
For more information, read the full prescribing information of Byooviz.
