Applies to voretigene neparvovec ophthalmic: intraocular suspension.

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.

For Healthcare Professionals

Applies to voretigene neparvovec ophthalmic: intraocular suspension.

General

The most commonly reported adverse reactions have included eye redness, cataract, increased intraocular pressure, and retinal tear.^[Ref]

Ocular

Very common (10% or more): Any ocular adverse reaction (up to 66%), conjunctival hyperemia/redness (up to 22%), cataract (up to 20%), increased intraocular pressure (up to 17%), retinal deposits (up to 10%), retinal tear (up to 10%)

Common (1% to 10%): Choroidal hemorrhage, conjunctival cyst, endophthalmitis, epiretinal membrane, eye disorder, eye inflammation/swelling, eye irritation, eye pain, foveal dehiscence (separation of the retinal layers in the center of the macula), foreign body sensation in the eye, foveal thinning, loss of foveal function, macular holes, macular pucker, maculopathy, retinal Haemorrhage, subretinal deposits, thinning of the corneal stroma (dellen)^[Ref]

Ocular adverse reactions were reported in 66% (27/41) of subjects (46 out of 81 injected eyes; 57%). Adverse reactions may have been due to this drug, the subretinal injection procedure, the concomitant use of corticosteroids, or a combination of the all three.^[Ref]