Lytenava

Lytenava (bevacizumab-vikg) is an intravitreal (into the eye) injection used to treat neovascular age-related macular degeneration (wet AMD), that is administered by a healthcare provider experienced in eye injections once a month.

Lytenava (bevacizumab-vikg) is a vascular endothelial growth factor (VEGF) inhibitor administered by a qualified eye care professional or healthcare provider experienced in eye injections once a month.

Bevacizumab has been used in eye care for many years, but until now there had not been a version approved by the FDA specifically for use in the eye. Lytenava is the first bevacizumab formulation developed and approved for injection into the eye rather than adapted from a product made for infusion into a vein.

In wet AMD, abnormal blood vessels grow under the retina and leak fluid and blood, which damages central vision. VEGF is a protein that drives this abnormal vessel growth. Lytenava (bevacizumab) works by attaching to VEGF and blocking it from binding to its receptors on the surface of blood vessel cells. Lytenava binds to all forms of VEGF-A, which reduces the growth of new blood vessels and the leakiness of existing ones. Slowing this process helps protect vision.

Lytenava (bevacizumab) received FDA approval on July 24, 2026, and is manufactured by Outlook Therapeutics Inc. Lytenava has not been shown to be safe or effective in children.

Eye infection and retinal detachment

Injections into the eye have been linked with endophthalmitis, a serious infection inside the eye, and with retinal detachment. Tell your eye doctor straight away if your eye becomes red, painful, or sensitive to light, or if your vision changes in the days after an injection. Early treatment can make a difference, so do not wait for your next appointment.

Increased pressure inside the eye

Eye pressure can rise in the 60 minutes following an injection. Your doctor will measure your eye pressure before and after treatment and manage it if needed.

Risk of blood clots

Medicines that block VEGF carry a possible risk of arterial thromboembolic events, which include nonfatal stroke, nonfatal heart attack, and death from a blood vessel cause. These events were uncommon in the Lytenava clinical trials, but the risk cannot be ruled out.

Do not receive Lytenava if you have:

• an infection in or around the eye
• active inflammation inside the eye
• a known allergy to bevacizumab products or to any ingredient in Lytenava.

An allergic reaction to this medicine can show up as severe inflammation inside the eye.

Before receiving Lytenava, tell your healthcare provider about all your medical conditions, including if you:

• Are pregnant or planning a pregnancy
• Are breastfeeding or planning to breastfeed.

Pregnancy

Because of the way bevacizumab works, Lytenava may pose a risk to a developing baby. There are no adequate studies in pregnant women or in pregnant animals, and it is not known whether the medicine can harm a fetus. It should be used during pregnancy only if it is clearly needed. Tell your doctor if you are pregnant or planning a pregnancy.

If you can become pregnant, use effective contraception during treatment and for at least 3 months after your last dose.

Breastfeeding

It is not known whether bevacizumab-vikg passes into breast milk or how it might affect a breastfed baby or milk supply. Because many medicines do pass into breast milk, caution is advised. You and your doctor can weigh the benefits of breastfeeding against your need for treatment.

The most common side effects of Lytenava that affect the treated eye are:

• Bleeding on the surface of the eye (conjunctival hemorrhage)
• Eye pain
• Vitreous floaters.

Less common effects in the treated eye, reported in fewer than 1% of people, were corneal abrasion, dry eye, eye irritation, and increased pressure inside the eye.

These are not all of the possible side effects. To report suspected side effects, contact Outlook Therapeutics Inc. at 1-833-999-OTLK (6855) or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Lytenava is given as an injection into the vitreous, the jelly-like substance inside the eye. It must be given by a qualified doctor using sterile technique, so you will receive it in a clinic or eye center rather than at home.

• The recommended dose is 1.25 mg (0.05 mL) into the affected eye once a month, about every 28 days.
• Each vial is used once and for one eye only. If both eyes need treatment, your doctor will use a fresh vial and new equipment for the second eye.
• Before the injection, you will be given an anesthetic to numb the eye and an antiseptic to reduce the risk of infection. Your eye pressure will be checked before the injection and again about 30 minutes afterwards.

In the days after treatment, there is a risk of infection inside the eye, retinal detachment, and inflammation inside the eye. Get immediate care from an ophthalmologist if your eye becomes red, painful, or sensitive to light, or if your vision changes.

Your vision may be temporarily disturbed after an injection and after the eye examinations that go with it. Do not drive or use machinery until your vision has recovered enough.

FDA approval was based on clinical trials comparing Lytenava with ranibizumab, another anti-VEGF injection used for wet AMD.

• In NORSE TWO (NCT03834753), 41.7% of people given monthly Lytenava gained at least 15 letters of vision by month 11, versus 23.1% on ranibizumab.
• NORSE EIGHT (NCT06190093) did not meet its non-inferiority margin at week 8, with vision improving 3.3 letters on Lytenava and 4.5 letters on ranibizumab.

Active ingredient: bevacizumab-vikg

Inactive ingredients: dibasic sodium phosphate 0.06 mg, monobasic sodium phosphate 0.29 mg, polysorbate 20 0.02 mg, trehalose 2.71 mg, and water for injection. The solution has a pH of 6.1 and contains no antimicrobial preservative.

Lytenava is manufactured by Outlook Therapeutics, Inc., 111 S. Wood Ave, Unit #100, Iselin, NJ 08830 U.S.U.S. License No.: 2292.