Voretigene neparvovec ophthalmic (for use in the eyes) is used to treat diseases of the retina that can cause night blindness, light sensitivity, and progressive vision loss.

Voretigene neparvovec ophthalmic is for use only in people with a specific gene mutation. Before you receive this medicine, you will need a medical test to make sure you have this gene mutation.

Your doctor will also determine whether you have enough remaining cells in your retina to be safely treated with this medicine.

Voretigene neparvovec ophthalmic may also be used for purposes not listed in this medication guide.

Voretigene neparvovec is not approved for use by anyone younger than 12 months or older than 65 years.

Tell your doctor if you are pregnant or breast-feeding.

Use Voretigene Neparvovec Ophthalmic (Intraocular) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

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

Voretigene neparvovec can cause changes in your retina that could lead to vision loss, including:

• new or worsening cataract (clouding of the lens inside of the eye);
• thinning of the clear layer in front of your eye;
• deposits under your retina;
• separating layers or a developing hole in the center of your retina;
• thinning of the retina or loss of function;
• breaks or wrinkling on the surface of your retina;
• retinal detachment;
• bleeding in the retina; or
• permanent decline in the sharpness of your vision.

Talk to your doctor about the risks and benefits of this medicine.

Call your doctor at once if you have:

• new or worsening vision problems;
• eye pain;
• flashes of light or "floaters" in your vision, seeing halos around lights; or
• signs of eye infection--eye pain or swelling, headache, increased sensitivity to light, crusting or drainage, vision loss.

Common side effects may include:

• eye pain, swelling, or redness;
• cataract (cloudy appearance in the eye);
• swelling of the eyelids; or
• increased pressure inside the eye.

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.

An air bubble will form inside your eye after treatment with this medicine. Your doctor will tell you when this air bubble has disappeared. Until that time, avoid air travel or scuba diving. These activities can cause permanent vision loss if the air bubble is still present.