FDA Approves Byooviz to Treat 3 Eye Conditions
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Key takeaways:
Byooviz (ranibizumab-nuna) is a biologic, meaning it’s a medication made from living organisms.
It’s the first biosimilar eye medication. A biosimilar is a biologic medication that’s very similar to another biologic. In this case, Byooviz is very similar to Lucentis, which means you can talk with your ophthalmologist about switching between the two medications.
An ophthalmologist can treat three eye conditions by injecting Byooviz into the back of your eye during an office visit.
As you get older, certain eye changes are normal. Older adults — people over 65 years of age — may need more time for their eyes to adjust to changes in light and brightness. These adults might also have a harder time seeing things up close or seeing a difference between certain colors.
But some people might have serious vision changes from certain eye conditions. These may include age-related macular degeneration (AMD), retinal vein occlusion (RVO), and myopic choroidal neovascularization (myopic CNV). These conditions can cause permanent vision loss, as they are not part of the natural process of getting older.
If you have a vision-threatening eye condition, like AMD or RVO, you might currently be receiving Lucentis (ranibizumab) injections. This is an expensive medication. Soon, you may have a lower-cost and effective option.
In mid-September 2021, the FDA approved Byooviz (ranibizumab-nuna). It's the first biosimilar eye product. Here, we’ll cover Byooviz — what it is and how it works — for three serious eye conditions.
What is Byooviz?
Byooviz is an FDA-approved injection given into the eye by an ophthalmologist. It can treat three different serious eye conditions. More on those conditions below.
Byooviz is a monoclonal antibody medication, which is a human-made protein that can bind to another protein. It attaches to — and stops — a protein called vascular endothelial growth factor (VEGF) in the back of the eye. VEGF helps the body make new blood vessels. By stopping VEGF, Byooviz can help control bleeding in the back of the eye.
Byooviz is made by Samsung Bioepis, a South Korean pharmaceutical company.
How is it dosed?
To receive Byooviz, you’ll need to see an ophthalmologist, who's a doctor that specializes in eye care. Initially, the doctor will likely give you one dose every month into the back of your eye.
After a few months, the dosing may begin to vary for each person.
Your ophthalmologist will want to regularly follow up with you while you’re receiving Byooviz. So try to keep these appointments to help your doctor make any necessary medication adjustments.
Which eye conditions does Byooviz treat?
Byooviz can treat wet AMD, RVO, and myopic CNV. Although these are different eye conditions, they can all cause vision problems. This includes vision loss from swelling and scarring caused by bleeding inside the eye.
Byooviz can help control this damage. These eye conditions are discussed more in detail in this table.
How does Byooviz compare to Lucentis?
Byooviz is an biosimilar with Lucentis. When compared to Lucentis, Byooviz is similarly effective and safe.
But what does “biosimilar” mean?
What is a biosimilar?
You may have heard of brand and generic medications. Brand and generic medications usually do the same job as each other, but they have different names. These terms apply to chemical-based medications.
But Lucentis and Byooviz are not chemical-based — they’re biologics, meaning they’re medications made from living things. Biologics are harder to make than chemical-based medications. They also aren’t labeled “brand” or “generic” medications.
When a biologic medication is made that’s very similar to a different biologic, it’s called a “reference,” or “biosimilar” medication. This is the same idea as a brand medication being similar to a generic medication.
In other words, Byooviz is a biosimilar. It’s not called a generic medication. Lucentis is a reference product. It’s not called a brand-name medication.
What are the potential side effects of Byooviz?
Like all medications, Byooviz has potential side effects. The following are common side effects of Byooviz:
Ruptured blood vessel in the eye
Eye pain
Floaters (specks) in field of vision
High eye pressure
Byooviz also has rare but potentially serious side effects. It’s recommended to seek medical attention if you experience any of the following:
Blood clots: Although rare, Byooviz can lead to blood clots, which could result in a heart attack or stroke. Symptoms of a heart attack include trouble breathing or pain in chest, back, or shoulders. Some symptoms of a stroke include trouble speaking and weakness of the face or on one side of the body.
Eye infections: After receiving Byooviz, there is a higher risk for an eye infection called endophthalmitis. This infection requires immediate medical attention. Symptoms include eye pain, light sensitivity, and changes in your vision.
High eye pressure: Although high eye pressure is a common side effect, it can be severe. Symptoms of high eye pressure may include eye pain, headache, and changes in vision.
Retinal detachment: Injections into the back of the eye increase the risk for retinal detachment. Symptoms of retinal detachment may include seeing a gray curtain in your field of vision, new floaters, or a shadow in your side vision.
When will Byooviz be available?
In the U.S., Byooviz has an anticipated availability of June 2022.
Byooviz probably won’t be available at standard community pharmacies. If you’re interested in trying Byooviz, speak to an ophthalmologist, who will be the one to inject the medication into the back of your eye. They can tell you if Byooviz is a viable option for you.
The bottom line
Byooviz is the first biosimilar eye product. It’s a biologic used to treat various serious eye conditions, including wet AMD, RVO, and myopic CNV. Although Byooviz received FDA approval, it won’t be available until June 2022. If you have any questions or concerns about Byooviz, please reach out to an ophthalmologist.
ABOUT THE AUTHOR:
Ross earned her doctorate in pharmacy (PharmD) at The University of Texas at Austin (UT Austin). Her years of experience practicing in various pharmacy settings also lead to multiple board certifications, including ambulatory care, geriatrics, and pharmacotherapy. She currently serves as the director of the PharmacyChecker international verification program.
Ross also founded Off Script Consults, a pharmacy consulting business. She strives to combine her passion for pharmacy, education, and writing to improve the quality of life and financial outcomes for people with chronic medical conditions, caregivers, and healthcare providers.
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