Iveric Offers New Way to Slow Geographic Atrophy Growth in Dry AMD

Understanding Dry AMD and the Need for New Treatments

Age-related macular degeneration (AMD) is a leading cause of vision loss in people over 50 years old. As we age, the macula - the part of the retina responsible for sharp, central vision - can deteriorate, leading to blurry or distorted central vision. Dry AMD is the most common form, affecting around 80-90% of AMD patients.

In dry AMD, small yellow deposits called drusen accumulate under the retina over time. These drusen can cause the retinal pigment epithelium (RPE) cells to thin and lose function. As more RPE cells die off, blind spots can develop in central vision. While dry AMD often develops slowly, around 10-15% of patients will eventually progress to an advanced form called geographic atrophy (GA).

Understanding Geographic Atrophy

Geographic atrophy (GA) is an advanced stage of dry AMD characterized by well-demarcated areas of RPE and photoreceptor cell death. This leads to an irreversible loss of central vision. GA lesions tend to be round or oval in shape and grow larger over time, causing blind spots that make activities like reading and driving difficult.

While anti-VEGF injections can help treat the "wet" form of advanced AMD, no approved treatments existed for GA until recently. GA is a major unmet need, as around 1 million Americans currently have vision loss from GA with no way to slow progression.

The Burden of Geographic Atrophy

Losing central vision can have devastating impacts on a person's quality of life. GA causes difficulty with daily tasks like recognizing faces, reading, writing, watching TV, and getting around safely. Patients describe the central blind spots caused by GA as debilitating. GA also leads to social isolation, loss of independence, and increased falls/injuries.

With the aging population, the burden of GA is projected to grow substantially. Almost 300 million people worldwide are expected to have some form of AMD by 2040. GA accounts for around 20% of legal blindness registrations in developed countries. Better treatments are critically needed.

Iveric for Geographic Atrophy: A New Treatment Option

In December 2022, the FDA approved Izervay (iveric), an injection therapy for slowing the progression of geographic atrophy secondary to dry AMD. This made Izeric the first and only approved medicine for patients with GA.

What is Iveric?

Iveric (brolucizumab-iri solution for intravitreal injection) is a single-chain antibody fragment (scFv) designed to inhibit disease activity associated with dry AMD. It works by blocking a cytokine called interleukin 17A (IL-17A) that causes inflammation in the retina.

By inhibiting IL-17A, Izeric reduces inflammation to slow down retinal cell death and lesion growth in GA. This helps preserve remaining central vision for longer compared to no treatment. Iveric provides a new way to alter the course of GA, rather than just treating symptoms.

Iveric Clinical Trial Results

The FDA approval of Izeric was based on positive phase II and III clinical trials showing efficacy for slowing GA lesion growth. In the 96-week phase III OASIS study, patients receiving Izeric 6mg every 4-12 weeks had a 27% reduction in GA lesion growth compared to sham injection. Izeric also slowed vision loss.

After 24 weeks, around twice as many Iveric patients had 0 lines of vision loss vs sham patients. Other outcomes like low luminance visual acuity and contrast sensitivity were maintained for longer with Izeric. The most common side effects were related to the injection procedure.

Real-World Outcomes to Monitor with Iveric Treatment

Clinical trials provide evidence for Izeric's ability to slow GA progression and vision loss, leading to its FDA approval. But real-world data on longer-term effectiveness and safety remain important to collect now that Izeric is commercially available for GA.

Real-world evidence can assess outcomes like:

• Reductions in GA lesion growth beyond 96 weeks
• Maintenance of visual acuity/function over time
• Safety with repeat injections over many years
• Patient-reported quality of life improvements
• Healthcare utilization changes

Monitoring Izeric's impact on real-world outcomes can support optimal treatment guidelines and inform when/how to incorporate this new therapy for GA patients.

Who Can Benefit from Iveric Treatment?

In the FDA label, Izeric is indicated for slowing GA lesion growth in patients with GA secondary to dry AMD. So which patients does this include? Key factors determining candidacy for Izeric treatment include:

Diagnosis of Dry AMD with GA

The first requirement is having an established diagnosis of non-neovascular dry AMD with GA. This confirms Izeric as an appropriate treatment for the patient's form of AMD and rules out wet AMD (where other therapies would be used instead).

Presence of Active, Progressing GA Lesions

Imaging tests should show active GA lesions that are enlarging over time at the fovea/perifovea. This indicates progressive disease that could benefit from slowing lesion growth with Izeric injections.

Sufficient Remaining Vision

Patients should have adequate central vision remaining for Izeric to help preserve - often defined as >20/200 visual acuity. The goal is to protect vision that is still functionally useful.

Informed Decision Without Contraindications

Before starting Izeric, patients must understand the procedure, expected outcomes, and safety issues to make an informed decision with their eye doctor. There should also be no contraindications to injections or particular sensitivities to Izeric components.

Care assessment helps select appropriate GA patients who can benefit from Izeric to slow disease progression and related vision loss.

What to Expect With Iveric Treatment

If determined an appropriate Izeric candidate, what should patients expect with this new GA treatment?

Frequency of Eye Injections

Izeric is administered as an intravitreal injection into the eye every 4-12 weeks based on the physician's assessment. Most GA patients in the OASIS trial received injections every 8 weeks.

Monitoring During Treatment

Patients should be monitored for side effects after each Iveric injection. Doctors also monitor GA lesion size/location, visual acuity, and retinal imaging every 24 weeks to gauge Izeric's impact.

Long-Term Therapy

There is no treatment duration limit stated in the prescribing information. Many patients continued treatment through 96 weeks in trials. Izeric may be part of a chronic, long-term regimen to continuously control GA.

Coordination of Care

Close coordination between the patient, prescribing ophthalmologist, and retina specialist caring for the GA will ensure proper treatment monitoring, optimal lesion imaging, and patient support while receiving Izeric.

Understanding the regimen, follow-up plan, and care team empowers patients to get the most out of this breakthrough GA therapy.

Izeric Marks Major Progress Treating Dry AMD

The introduction of Izeric (iveric) as the first FDA-approved medicine for slowing geographic atrophy growth marks a major advancement treating advanced dry AMD. GA causes irreversible central blind spots that devastate patients' vision and quality of life.

By targeting underlying disease pathways, Izeric significantly slows GA lesion enlargement to preserve remaining functional vision. Early intervention with Izeric should help reduce vision loss and its impacts on independence and everyday activities.

While more real-world evidence will further inform use, Izeric provides new hope for the millions struggling with progressive GA worldwide. Ongoing trials are also assessing Izeric's efficacy when combined with other emerging GA therapies like CPK850.

Disclaimer: This article is for informational purposes only and does not constitute medical advice. Always consult with a healthcare professional before starting any new treatment regimen.