Revakinagene Taroretcel Side Effects

Applies to revakinagene taroretcel: intravitreal implant.

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

Revakinagene taroretcel may cause some side effects following the procedure. Call your doctor at once if you have: worsening eye swelling, redness, severe discomfort, crusting, discharge, a cloudy or hazy appearance over your eye or in your vision, seeing halos around lights, seeing flashes of light, vision loss, bleeding inside your eye, increased sensitivity to light, irritation, or other surgical complications such as discomfort due to the implant moving out of place (implant extrusion).

Common side effects may include:

• eye pain, redness, discharge, dryness, itching or irritation;

• feeling like something is in your eye;

• trouble seeing in the dark;

• seeing "floaters" in your vision; or

• headache.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

See also:

For healthcare professionals

Applies to revakinagene taroretcel: intravitreal implant.

General adverse events

The most common adverse reactions were conjunctival hemorrhage, delayed dark adaptation, foreign body sensation, eye pain, suture related complications, miosis, conjunctival hyperemia, eye pruritus, ocular discomfort, vitreous hemorrhage, blurred vision, headache, dry eye, eye irritation, cataract progression or formation, vitreous floaters, severe vision loss, eye discharge, anterior chamber cell, and iridocyclitis.^[Ref]

Nervous system

• Common (1% to 10%): Headache^[Ref]

Ocular

• Very common (10% or more): Conjunctival hemorrhage (up to 31%), delayed dark adaptation (up to 23.1%), miosis (up to 15.4%), eye pain (up to 15%), foreign body sensation in eyes (up to 15%), conjunctival hyperemia (up to 11%)
• Common (1% to 10%): Anterior chamber cell, blurred vision, cumulative cataract incidence, dry eye, eye discharge, eye irritation, eye pruritus, iridocyclitis, ocular discomfort, severe visual loss (more than 15 letters), vitreous hemorrhage, vitreous floaters^[Ref]

Severe visual loss included one case of visual loss due to cataract formation.^[Ref]

Other

• Very common (10% or more): Suture related complication (up to 15.4%)^[Ref]

Suture related complications included exposed suture, foreign body sensation, conjunctival wound dehiscence, painful sutures, suture irritation, suture granuloma, scleral wound opening, and itchy suture.^[Ref]

Further information

Revakinagene taroretcel side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer