FDA Approves Byooviz for Treatment of Age-Related Macular Degeneration (AMD)

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.
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 equally 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.

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.

	Wet age-related mascular degeneration (AMD)	Retinal vein occlusion (RVO)	Myopic choroidal neovascularization (CNV)
What is it?	All three of these conditions are caused by damage in the back of the eye. The part of the eye that’s affected is called the macula, which is the part that allows for sharp vision and helps you see colors.
Who is most affected?	AMD is the leading cause of blindness in the U.S. It affects about 15 million people in the U.S., most often older adults (i.e., those over age 65).	RVO mostly occurs in older adults. It affects more than 16 million people worldwide.	Myopia (nearsightedness) affects more than 34 million U.S. adults older than 40 years. It’s thought that up to 11% of people with severe myopia may develop myopic CNV.
What happens in this condition?	People with AMD might have trouble seeing fine details because of damage to the macula. The damage is due to blood leaking into the macula.	In RVO, veins are blocked in the retina. This is the light-sensitive part in the back of the eye. These blocked veins leak blood and fluid into the macula, which leads to macular swelling. This leakage can cause vision loss or blurry vision.	In myopic CNV, leaky blood vessels cause macular damage. This can cause blurry vision, problems with vision in the center of your eye, and vision loss. Bleeding in the macula can also happen because of lesions (cuts) in Bruch’s membrane, which is a stretchy film that covers over half of the eye.

Wet age-related mascular degeneration (AMD)

Retinal vein occlusion (RVO)

Myopic choroidal neovascularization (CNV)

What is it?

All three of these conditions are caused by damage in the back of the eye. The part of the eye that’s affected is called the macula, which is the part that allows for sharp vision and helps you see colors.

Who is most affected?

AMD is the leading cause of blindness in the U.S. It affects about 15 million people in the U.S., most often older adults (i.e., those over age 65).

RVO mostly occurs in older adults. It affects more than 16 million people worldwide.

Myopia (nearsightedness) affects more than 34 million U.S. adults older than 40 years.

It’s thought that up to 11% of people with severe myopia may develop myopic CNV.

What happens in this condition?

People with AMD might have trouble seeing fine details because of damage to the macula. The damage is due to blood leaking into the macula.

In RVO, veins are blocked in the retina. This is the light-sensitive part in the back of the eye. These blocked veins leak blood and fluid into the macula, which leads to macular swelling. This leakage can cause vision loss or blurry vision.

In myopic CNV, leaky blood vessels cause macular damage. This can cause blurry vision, problems with vision in the center of your eye, and vision loss.

Bleeding in the macula can also happen because of lesions (cuts) in Bruch’s membrane, which is a stretchy film that covers over half of the eye.

How does Byooviz compare to Lucentis?

Byooviz is a biosimilar to Lucentis. When compared to Lucentis, Byooviz is similarly effective and safe.

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.

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Written by:

Ross Phan, PharmD, BCACP, BCGP, BCPS

Ross Phan is a board-certified clinical pharmacist. She has roughly two decades of healthcare experience — with most of her experience being pharmacy related.

Edited by:

Joshua Murdock, PharmD, BCBBS

Joshua Murdock, PharmD, BCBBS, is a licensed pharmacist in Arizona, Colorado, and Rhode Island. He has worked in the pharmacy industry for more than 10 years and currently serves as a pharmacy editor for GoodRx.

Reviewed by:

Christina Aungst, PharmD

Christina Aungst, PharmD, is a pharmacy editor for GoodRx. She began writing for GoodRx Health in 2019, transitioning from freelance writer to editor in 2021.

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