CLINICAL Study results
IZERVAY slowed GA progression in just one year

Slowing GA progression may help to preserve vision longer.

IZERVAY was evaluated in 2 clinical trials of over 700 people with GA. In both trials, GA progression was slower for people receiving IZERVAY compared to those that were not treated.

In just one year, compared to those that did not receive treatment,
IZERVAY slowed GA progression by:

Trial 1

(N=177)

GA Progression
35%

Slower Progression

in just one year of treatment

Trial 2

(N=447)

GA Progression
18%

Slower Progression

in just one year of treatment

How IZERVAY works
Only IZERVAY directly targets C5, a key source of retinal cell death and loss of photoreceptors
GA Immune System
GA is related to immune system overactivity
In people with GA, a part of the immune system becomes overactive.
C5 signals an attack response
C5 signals an attack response
A protein called C5 signals other proteins to start attacking retinal cells.
How Izervay Works
IZERVAY
blocks C5
IZERVAY blocks the C5 protein to help protect healthy retinal cells and photoreceptors.
How GA Impacts Vision
Side effects
IZERVAY was studied in 2 clinical trials

Less than 2% of people stopped treatment due to side effects.

The most common side effects experienced at 12 months were:

Treated with
IZERVAY (n=292)
Not treated with
IZERVAY (n=332)
Blood in the white of the eye 13% 9%
Increased eye pressure 9% 1%
Blurred vision* 8% 5%
Wet AMD 7% 4%
Eye pain 4% 3%
Spots in vision 2% <1%
Eyelid inflammation 2% <1%
*Blurred vision includes visual impairment and/or loss of sharpness or detail in vision at a distance.
These are not all the possible side effects of IZERVAY. Talk to your doctor if you think you might be experiencing side effects.

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INDICATION AND IMPORTANT SAFETY INFORMATION

INDICATION AND IMPORTANT SAFETY INFORMATION

What is IZERVAY?

IZERVAY (avacincaptad pegol intravitreal solution) is a prescription eye injection, used to treat geographic atrophy (GA), the advanced form of dry age-related macular degeneration (AMD).

What is the most important information I should know about IZERVAY?
Do NOT receive IZERVAY if you:
  • Have an infection in or around your eye
  • Have active swelling in or around your eye that may include pain and redness
IZERVAY can cause serious side effects:
  • Eye injections like the one for IZERVAY can cause an eye infection (endophthalmitis) or separation of layers of the retina (retinal detachment).
  • Call your healthcare provider right away if you have redness of the eye, eye pain, increased discomfort, worsening eye redness, blurred or decreased vision, an increased number of small specks floating in your vision, flashes of light, or increased sensitivity to light.
  • There is a risk of developing wet AMD with IZERVAY. You should report any symptoms (visual distortions such as straight lines seeming bent, deterioration in vision, dark spots, loss of central vision) to your healthcare provider to monitor.
  • IZERVAY may cause a temporary increase in eye pressure within minutes after the injection. Your healthcare provider will monitor this after each injection.
Before receiving IZERVAY tell your healthcare provider about all of your medical conditions including if you:
  • Have a history of seeing flashes of light or small specks floating in your vision and if you have a sudden increase of size and number of these specks.
  • Have high pressure in the eye or if you have glaucoma.
  • Are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine.
  • Are taking any medications, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Tell your healthcare provider about any medicine you take.
What should I avoid while receiving IZERVAY?
  • Your vision may be impaired after receiving an eye injection or after an eye exam. Do not drive or use machinery until your vision has recovered sufficiently.
What are the most common side effects of IZERVAY?
  • Blood in the white of the eye
  • Increase in eye pressure
  • Blurred vision
  • Wet age-related macular degeneration

These are not all the possible side effects of IZERVAY. Tell your healthcare provider about any side effect that bothers you or that does not go away.

Call your healthcare provider for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. To request medical information or to report an adverse event or product complaint, please call 1-800-727-7003 or send an email to medinfo.americas@astellas.com.

Please see full Prescribing Information for more information.