Lucentis

Lucentis is made from a human antibody fragment. It works by keeping new blood vessels from forming under the retina (a sensory membrane that lines the inside of the eye). In people with certain types of eye disorders, new blood vessels grow under the retina, where they leak blood and fluid.

Lucentis is used to treat the "wet form" of age-related macular degeneration (called neovascular AMD) and is also used to treat macular edema following retinal vein occlusion (RVO), diabetic macular edema (DME), diabetic retinopathy (DR), and myopic choroidal neovascularization (mCNV).

Lucentis first gained FDA approval on June 30, 2006. There are currently 4 interchangeable biosimilars for Lucentis:

• Byooviz (ranibizumab-nuna), an interchangeable biosimilar manufactured by Samsung Bioepis Co., Ltd., (FDA approval September 20, 2021)
• Cimerli (ranibizumab-eqrn), an interchangeable biosimilar manufactured by Sandoz Inc., (FDA approval August 2, 2022)
• Nufymco (ranibizumab-leyk), an interchangeable biosimilar manufactured by Formycon AG (FDA approval December 18, 2025)
• Ranluspec (ranibizumab-hkdz), an interchangeable biosimilar manufactured by Lupin Pharmaceuticals, Inc. (FDA approved June 2, 2026).

Susvimo (ranibizumab) is a refillable implant containing ranibizumab that is surgically inserted into the eye during a one-time, outpatient procedure. It is manufactured by Genentech, Inc., (FDA approval October 25, 2021).

Lucentis is given as an injection into your eye. Your doctor will use a medicine to numb your eye before giving you the injection. You will receive this injection in your doctor's office or other clinic setting.

For a short time after your injection, your eyes will be checked periodically to make sure the injection has not caused any side effects.

Lucentis is usually given once every month.

For people with macular degeneration: After you have received the first 3 or 4 injections, your doctor may change your injection schedule to once every 3 months.

Follow your doctor's dosing instructions very carefully. The timing of your monthly injections is very important for this medication to be effective.

To be sure Lucentis is helping your condition and is not causing harmful effects, your eyes will need to be checked on a regular basis. Do not miss any follow-up visits to your doctor.

You should not receive Lucentis if you are allergic to ranibizumab or if you have any type of infection in or around your eyes.

Before you receive Lucentis, tell your doctor if you have glaucoma or a history of blood clots or stroke.

Call your doctor at once if you have sudden vision problems, eye pain or irritation, discharge or bleeding from the eye, swelling around your eye, seeing flashes of light or "floaters" in your vision, sudden numbness or weakness in your body, sudden severe headache, or problems with speech or balance.

The timing of your monthly injections is very important for this medication to be effective. Call your doctor for instructions if you miss an appointment to receive your Lucentis injection.

Do not receive Lucentis if you have a known hypersensitivity to ranibizumab, Lucentis, or have an active infection in or around your eyes.

To make sure Lucentis is safe for you, tell your doctor if you have:

• glaucoma; or
• a history of blood clots or stroke.

It is not known whether Lucentis will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant. This medicine may affect your ability to have children.

It is not known whether ranibizumab passes into breast milk or if it could affect the nursing baby. Tell your doctor if you are breast-feeding.

Get emergency medical help if you have signs of an allergic reaction to Lucentis: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• eye pain or redness, swelling around your eyes;
• blurred vision, tunnel vision, eye pain, or seeing halos around lights;
• increased sensitivity to light;
• discharge or bleeding from the eye;
• seeing flashes of light or "floaters" in your vision;
• sudden numbness or weakness (especially on one side of the body); or
• sudden severe headache, problems with speech or balance.

Common Lucentis side effects may include:

• eye pain or irritation;
• feeling like something is in your eye;
• itchy or watery eyes;
• dry eyes, puffy eyelids;
• blurred vision;
• sinus pain, sore throat, cough; or
• nausea.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Usual Adult Dose for Macular Degeneration:

0.5 mg via intravitreal injection once a month (approximately 28 days)Use: Neovascular (wet) age-related macular degeneration (AMD)

Usual Adult Dose for Diabetic Retinopathy:

-DME and Diabetic Retinopathy:0.3 mg via intravitreal injection once a month (approximately 28 days)-Macular Edema following RVO:0.5 mg via intravitreal injection once a month (approximately 28 days)Uses: Diabetic macular edema (DME); diabetic retinopathy (DR); macular edema following retinal vein occlusion (RVO)

Usual Adult Dose for Macular Edema:

-DME and Diabetic Retinopathy:0.3 mg via intravitreal injection once a month (approximately 28 days)-Macular Edema following RVO:0.5 mg via intravitreal injection once a month (approximately 28 days)Uses: Diabetic macular edema (DME); diabetic retinopathy (DR); macular edema following retinal vein occlusion (RVO)

Usual Adult Dose for Myopic Choroidal Neovascularization:

0.5 mg via intravitreal injection once a month (approximately 28 days) for up to 3 months.Use: Myopic choroidal neovascularization (mCNV)

Call your doctor for instructions if you miss an appointment to receive your Lucentis injection.

Since this medicine is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

This medication may cause blurred vision. Be careful if you drive or do anything that requires you to be able to see clearly.

Other drugs may interact with ranibizumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Other drugs may interact with ranibizumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Biosimilar and interchangeable products are biological products that are highly similar to and have no clinically meaningful differences from the reference product.

Reference products

These are biological products that have already been approved by the FDA, against which biosimilar products are compared. There are 2 for Lucentis.

Lucentis (ranibizumab) - Genentech, Inc.

Susvimo (ranibizumab) - Genentech, Inc.

View Susvimo information in detail.

Lucentis interchangeable products

Interchangeable biosimilar products can be dispensed by a pharmacist without the intervention of the prescriber of the reference product.

Pharmacy laws for biosimilar prescribing may vary by state.

Byooviz (ranibizumab-nuna) - Samsung Bioepis Co., Ltd.

View Byooviz information in detail.

Cimerli (ranibizumab-eqrn) - Sandoz Inc.

View Cimerli information in detail.

Nufymco (ranibizumab-leyk) - Zydus Lifesciences Global FZE

View Nufymco information in detail.