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  5. Drug Trials Snapshots: IZERVAY
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Drug Trials Snapshots: IZERVAY

HOW TO USE THIS SNAPSHOT
The information provided in Snapshots highlights who participated in the key clinical trials that supported the original FDA approval of this drug, and whether there were differences among sex, race, age, and ethnic groups. The “MORE INFO” bar shows more detailed, technical content for each section. The Snapshot is intended as one tool for consumers to use when discussing the risks and benefits of the drugs.

LIMITATIONS OF THIS SNAPSHOT
Do not rely on Snapshots to make decisions regarding medical care. Always speak to your healthcare provider about the benefits and risks of a drug.

Some of the information in this Snapshot is for presentation purposes and does not represent the approved conditions of use of this drug. Refer to the IZERVAY Prescribing Information for all the approved conditions of use of this drug (e.g., indication(s), population(s), dosing regimen(s), safety information). Snapshots are limited to the information available at the time of the original approval of the drug and do not provide information on who participated in clinical trials that supported later approvals for additional uses of the drug (if applicable).

IZERVAY (avacincaptad pegol intravitreal solution
(ahy-zer-vey)
IVERIC bio, Inc.
Approval date: August 4, 2023

DRUG TRIALS SNAPSHOT SUMMARY:

What is the drug for?

IZERVAY is an RNA aptamer, a PEGylated oligonucleotide that is approved for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD).

How is this drug used?

IZERVAY is a sterile, aqueous solution for intravitreal injection that is administered to each affected eye once monthly (approximately every 28±7 days).

Who participated in the clinical trials?

The FDA approved IZERVAY based on evidence from two clinical trials (OPH2003 and (ISEE2008) of 625 patients with GA secondary to AMD. The trials were conducted at 268 sites in 18 countries including the United States, Argentina, Australia, Austria, Belgium, Brazil, Canada, Colombia, Czechia, Croatia, Germany, Spain, France, Hungary, Israel, Italy, Latvia, and Poland. Of the 625 subjects, 316 (50.6%) were from the United States.

How were the trials designed?

The two trials were randomized, multi-center, double-masked, sham-controlled studies. Patient ages ranged from 51 to 97 years with a mean of 77 years. In total, 292 patients with AMD were treated with IZERVAY 2 mg, and 332 patients with AMD received sham. In both studies, the primary efficacy endpoint was the mean rate of GA growth (slope) from baseline to Month 12, measured by fundus autofluorescence evaluated at three time points: baseline, Month 6, and Month 12.

DEMOGRAPHICS SNAPSHOT

Figure 1 summarizes how many male and female patients were enrolled in the combined clinical trials used to evaluate the efficacy of IZERVAY.

Figure 1. Baseline Demographics by Sex

Pie chart summarizing how many male and female patients were in the clinical trial. In total, 190 (30%) male patients and 434 (70%) female patients participated in the clinical trial.

Source: Adapted from FDA Review

Figure 2 summarizes how many patients by race were enrolled in the combined clinical trials used to evaluate the efficacy of IZERVAY.

Figure 2. Baseline Demographics by Race

Pie chart summarizing how many White, Black or African American, Asian or Pacific Islander, and other patients were in the clinical trial. In total, 542 (86.9%) White patients, 2 (0.3%) Black or African American patients, 2 (0.3%) Asian or Pacific Islander patients, and 78 (20%) other patients participated in the clinical trial.

Source: Adapted from FDA Review

Figure 3 summarizes how many patients by age were enrolled in the combined clinical trials used to evaluate the efficacy of IZERVAY.

Figure 3. Baseline Demographics by Age

Pie chart summarizing how many patients by age were in the clinical trial. In total, 55 (9%) patients younger than 65 years of age, 177 (28%) patients between 65 and 74 years of age, 253 (41%) patients between 75 and 84 years of age, and 139 (22%) patients 85 years of age or older participated in the clinical trial.

Source: Adapted from FDA Review

Figure 4 summarizes how many patients by ethnicity were enrolled in the combined clinical trials used to evaluate the efficacy of IZERVAY.

Figure 4. Baseline Demographics by Ethnicity

Pie chart summarizing how many Hispanic, not Hispanic, and other patients were in the clinical trial. In total, 53 (9%) Hispanic or Latino patients, 520 (83%) not Hispanic or Latino patients, and 51 (8%) other patients participated in the clinical trial.

Source: Adapted from FDA Review

What are the benefits of this drug?

The results of the primary efficacy analyses in the two studies demonstrated the efficacy of IZERVAY for the treatment of GA secondary to AMD in slowing the growth of GA lesion.

Were there any differences in how well the drug worked in clinical trials among sex, race, and age?

  • Sex: The observed effect of IZERVAY was larger for females than males. Because of limited data, this difference may be due to chance.
  • Race: The number of patients of races other than White was small; therefore, differences in how IZERVAY worked among races could not be determined.
  • Age: The observed effect of ZERVAY was larger for participants older than 85 years of age. Because of limited data, this difference may be due to chance.

What are the possible side effects?

The most common adverse reactions were conjunctival hemorrhage, increased intraocular pressure, blurred vision, and neovascular AMD.

Were there any differences in side effects among sex, race and age?

Overall, the study population had a mean age of 77 years, was majority female (69%) and White (82%), which is consistent with the disease population.

  • Sex: The occurrence of side effects was similar in males and females.
  • Race: Because 82% of the study population was White consistent with the disease population, no conclusion can be made regarding the occurrence of side effects by race.
  • Age: Because 91% of the study population was over age 65 years consistent with the disease population, no conclusion can be made regarding the occurrence of side effects based on age younger and older than 65 years of age.

GLOSSARY

CLINICAL TRIAL: Voluntary research studies conducted in people and designed to answer specific questions about the safety or effectiveness of drugs, vaccines, other therapies, or new ways of using existing treatments.
COMPARATOR: A previously available treatment or placebo used in clinical trials that is compared to the actual drug being tested.
EFFICACY: How well the drug achieves the desired response when it is taken as described in a controlled clinical setting, such as during a clinical trial.
PLACEBO: An inactive substance or “sugar pill” that looks the same as, and is given the same way as, an active drug or treatment being tested. The effects of the active drug or treatment are compared to the effects of the placebo.
SUBGROUP: A subset of the population studied in a clinical trial. Demographic subsets include sex, race, and age groups.

PRESCRIBING INFORMATION

 

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