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

Luxturna is for use only in people with a specific gene mutation. Before you receive Luxturna, 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.

Luxturna may also be used for purposes not listed in this medication guide.

Voretigene neparvovec can cause changes in your retina that could lead to vision loss. Talk to your doctor about the risks and benefits of Luxturna.

Luxturna is given as a one-time injection into each eye. You will receive this injection in your doctor's office or other clinic setting.

You may be given a steroid medication to take by mouth, starting 3 days before your injection. Keep using the steroid for as long as your doctor has prescribed.

Voretigene neparvovec is usually given into each eye at separate times, at least 6 days apart.

Your doctor will use a medicine to numb your eye before giving you the voretigene neparvovec injection.

For at least 24 hours after each injection, you will need to rest lying down as much as possible.

Your eyes will be checked periodically to make sure the medicine has been effective and has not caused serious side effects.

You should not stop using the steroid medication suddenly. Follow your doctor's instructions about tapering your dose.

Small amounts of Luxturna will remain in your tears for a short period of time. For at least 7 days after each injection: place all used bandages, eye dressings, or used tissues into sealed bags and throw them away in the trash.

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.

Voretigene neparvovec is used as a single dose and does not have a daily dosing schedule.

Call your doctor if you miss a dose of your steroid medication. The timing of your steroid doses in relation to your voretigene neparvovec injection is very important in preventing certain side effects.

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

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.

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.

Luxturna may cause serious side effects. 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 of Luxturna 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.