FDA Approves Lytenava Eye Injection for Wet Age-Related Macular Degeneration

Lytenava (bevacizumab) is now FDA approved to treat adults with neovascular age-related macular degeneration, which is also called wet AMD. Wet AMD is an eye disease that affects the center of your vision. It can cause rapid vision loss, especially in older adults. This happens when weak, abnormal blood vessels grow in the back of the eye and leak blood or fluid.

Lytenava works by targeting and blocking a protein in the body called VEGF. High levels of VEGF cause extra blood vessels to grow and leak in the eye. By blocking this protein, Lytenava stops new blood vessels from growing and reduces fluid leakage. This helps slow down vision loss.

Similar medicines have been used in the eye for many years. But Lytenava is the first version of bevacizumab made specifically for use as an eye injection.

Why Was Lytenava Approved?

The approval of Lytenava was based on a clinical study called NORSE TWO. The study included 228 adults with wet AMD. People in the study were placed into two treatment groups. One group received Lytenava injections once a month. The other group received ranibizumab, another eye injection that blocks VEGF, once a month for three months and then once every three months.

At 11 months, some people in both groups were able to read at least 15 more letters on an eye chart than they could when the study started. This happened more often in people who were treated with monthly Lytenava injections than in people who received ranibizumab every three months. But it isn’t clear whether Lytenava works better than ranibizumab. Other studies have shown that monthly injections of ranibizumab are better for improving vision than shots given only every three months.

In the study, Lytenava was well-tolerated. The most common side effect in the trial was minor bleeding on the surface of the eye. Other common findings included mild eye pain and seeing floaters.

What Do I Need to Know About Lytenava?

Lytenava is given as an injection directly into the eye by a qualified health care provider. Your health care provider will numb your eye before the shot. They will also check the pressure inside your eye before and after the shot to make sure it remains safe.

The most common side effects of Lytenava include eye pain, seeing floaters, and red spots caused by bleeding on the surface of the eye. Rare but serious side effects can also happen. These include eye infections, a detached retina, or a sudden increase in eye pressure. There is also a small risk of blood clots, heart attack, or stroke with medicines that block VEGF (like Lytenava).

Your vision may be temporarily blurry after receiving an eye injection or eye exam. Do not drive or operate machinery until your vision clears up completely. Tell your health care provider right away if your eye becomes red, painful, sensitive to light, or if you notice other changes in your sight after treatment.

If you are pregnant, planning to become pregnant, or breastfeeding, discuss this with your health care provider. Women who can get pregnant should use effective birth control while receiving Lytenava and for at least three months after their final injection.