People with a condition called wet age-related macular degeneration (AMD) often receive eye injections. These eye injections can help to improve vision and also stop the damage that causes vision to get worse. Many different eye injections have been approved to treat wet AMD. Most of these medicines are called anti-VEGF therapies because they block a substance in the eye called VEGF.
In 2022, Vabysmo became the first eye injection that could block two substances (VEGF and another substance called Ang-2) in people with wet AMD. This may allow people to receive their eye injections less often.
How Does Vabysmo Work for Wet AMD?
As a person ages, they may develop a condition that causes their vision to change. One of the most common eye conditions in older people is called age-related macular degeneration (AMD). This condition affects the retina, which is the layer of the eye that processes the images that you see. The center portion of the retina is called the macula. This portion processes the images in the center of your vision (right in front of you). In AMD, the macula becomes worn down and stops working as well.
When AMD develops, it may not cause any symptoms. Over time, though, it may cause blurry vision and change the appearance of colors. Some people may also develop dark areas in the center of their vision. In dry AMD, which is the most common type of AMD, vision slowly gets worse over time as the cells in the macula wear out and die off. This can eventually lead to blind spots in the center of your vision.
The most serious type of AMD is called wet AMD. In this form of AMD, small blood vessels begin to leak blood and fluid into the macula. The eye may begin to grow new blood vessels to replace the leaky blood vessels. These new blood vessels may also be unstable and leaky. This can cause a person’s vision to get worse very quickly. If wet AMD is not treated, a person can lose all of their central vision.
The key to treating wet AMD is to limit or stop the damage to the macula that is being caused by the leaky blood vessels. Stopping the damage can help to improve vision and may also help to stop vision problems from getting much worse.
There are many medicines that can help to stop the eye damage that occurs in wet AMD. All of these medicines are injected into the eye. They work by blocking a substance called VEGF, which plays an important part in forming new blood vessels in the eye. By blocking VEGF, these medicines can slow down the formation of new blood vessels in the eye.
The active ingredient in Vabysmo is a medicine called faricimab. Like many of the other medicines that are used to treat wet AMD, this medicine blocks VEGF. Unlike those other medicines, Vabysmo also blocks another substance called Ang-2. Having too much Ang-2 in the eye can make blood vessels unstable and leaky. By blocking both VEGF and Ang-2, Vabysmo can stop the eye from growing as many new blood vessels and also help to make the current blood vessels more stable. This can reduce the leakiness and buildup of fluid that causes vision issues.
How Was It Studied?
Two clinical studies were done to see if Vabysmo was safe and effective for the treatment of wet AMD. Everyone was at least 50 years old, with an average age of about 75. A little more than half of the people in the studies were female (60%). Most of the people in the studies were White (87%) and about 9% were Asian. About 10% of people identified as Hispanic or Latino. Less than 1% of people identified as Black or African American, and less than 1% identified as American Indian or Alaska native.
All of the people in these studies had wet AMD and had started to grow new blood vessels in their eyes. Most people (about 69%) were diagnosed with wet AMD less than 1 month before the study started.
Vabysmo was compared with a medicine called aflibercept (Eylea). Aflibercept blocks VEGF and is injected into the eye. The people in the studies did not know which medicine they were receiving. During the study, everyone received injections multiple times, but some people had injections more often than other people. Depending on the person and the medicine they were receiving, the injections could be given every 8 weeks, 12 weeks, or 16 weeks.
These studies measured effectiveness by testing each person’s best possible vision while wearing their glasses or contacts. This test was done before the study started and again after about 12 months. Since vision can change from day to day, everyone in the study completed the test multiple times to make sure that the test was accurate.
What Benefits Were Seen in These Studies?
Overall vision. After 1 year of treatment, people who used Vabysmo could see better than they could before the study started. People who used aflibercept could also see better than they could before the study started. These improvements in vision were similar for everyone in the study, no matter which medicine they were using.
Total number of injections needed. Everyone received an injection once every month when the study started, but then the injection schedule changed. The people who used aflibercept received an injection every 8 weeks. The people who used Vabysmo received an injection every 8 weeks, 12 weeks, or 16 weeks. This schedule was chosen after running tests on each person’s eyes.
About 75% of people needed an injection of Vabysmo every 12-16 weeks. A little less than half received Vabysmo every 16 weeks, and about one-third received Vabysmo every 12 weeks. These people had the same improvements in their vision as the people who received aflibercept every 8 weeks.
Does the Medicine Keep Working After the First Year?
Both of these studies were continued for 2 years. On average, the people in these studies could see better after 2 years than they had at the beginning of the study. Since people with wet AMD tend to lose their vision relatively quickly, their vision would usually be much worse after 2 years. This means that both of these medicines were helping to stop the damage to the eye.
After 2 years, more people were able to get their Vabysmo injections less often. Almost two-thirds of people only needed it every 16 weeks, and about 15% of people needed it every 12 weeks. The people who received Vabysmo every 12-16 weeks had similar improvements in their vision as the people who received aflibercept every 8 weeks. This means that many people who use Vabysmo may only need an injection every 3-4 months (once they have received their first four injections).
How Do I Use It?
Vabysmo is a liquid injected directly into the eye by a health care professional. This type of injection is called an intravitreal injection. When you start using Vabysmo, you will receive an injection every 4 weeks. After four doses, your health care professional will order tests to evaluate your eye function. After ordering these tests, you may continue to receive Vabysmo every 8 weeks, 12 weeks, or 16 weeks. Most people only need a dose every 12-16 weeks. Your health care professional will decide how often you should receive Vabysmo and for how long.
When it is time to receive your injection, your health care professional will set up a device that will hold your eye open. Then they will place some drops into your eye. These drops will help to numb your eye during the injection and prevent infections. Before giving the injection, they may also wash out your eye with a solution that kills bacteria.
The pressure in your eye might increase right after receiving the injection of Vabysmo. This increased pressure usually goes away within an hour after the injection. Your health care provider will monitor your eye and your symptoms after each injection. During that time, it is important for you to let someone know if you are experiencing any pain in the eye or major changes to your vision.
How Quickly Will Vabysmo Work for Wet AMD?
If Vabysmo is working, you will start to notice your vision improve within the first few weeks after your first injection. Over the first 3 months, you will receive an injection every 4 weeks and your vision may continue to get better during this time.
It is important that you go to every appointment and receive all of your scheduled injections. If you will not be able to make it to an appointment, call your health care provider right away to reschedule your injection.
How Can I Prevent or Manage Side Effects?
Your vision may become blurry for a little while after you receive your Vabysmo injection. This short-term blurry vision is a normal side effect. While you wait for your vision to return to normal, it is best not to drive or operate any machinery.
In rare cases, Vabysmo can cause other types of changes to your vision, such as seeing floating dark spots or lines, flashing lights, or the sense that a curtain has been drawn over parts of your eye. These vision changes may be a sign of a serious condition. If you experience any of these vision changes or have severe eye pain, call 911.
These are not all of the possible side effects of Vabysmo. Talk with your health care provider if you are having symptoms that bother you. If you experience anything that you think may be caused by Vabysmo, you can also report side effects to the FDA at 800-FDA-1088.
Are There Any Interactions With Other Medicines?
There are no known interactions between Vabysmo and other medicines. But it is still important for your health care provider to be aware of all the prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, or other supplements you take or have recently taken.
Is There a Coupon Card Available?
There is a savings coupon available from the manufacturer that may allow you to pay $0 for your prescription. Whether you are eligible depends on whether you have prescription insurance and what type of insurance you have. You can find out more at www.vabysmo.com/dme/financial-support/assistance-options.html.
