Iveric Bio, Inc., an Astellas Pharma Inc. company, has received FDA approval for IZERVAY (avacincaptad pegol intravitreal solution) for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD).
Remind me … Astellas owns Iveric?
Yup! The second-largest Japanese pharmaceutical company purchased Iveric in May 2023 for an estimated $5.9 billion, making Iveric a whole-subsidiary of Astellas.
Read our coverage here.
Now talk about IZERVAY.
Developed under the name ACP/Zimura, IZERVAY (pronounced EYE-ZER-VEY) is a complement C5 inhibitor.
Overactivity within the complement system and the C5 protein are thought to play key roles in the development and growth of scarring and vision loss linked with GA secondary to AMD.
How does it work?
By focusing on C5, IZERVAY could potentially decrease the complement system’s activity that could lead to retinal cell degeneration—thus possibly slowing GA progression.
What’s the recommended dosage?
Per the prescribing information, a 2 mg (0.1 mL of 20 mg/mL solution) is to be administered via intravitreal injection to each affected eye once a month for up to 12 months.
Gotcha. Any clinical data on it?
The approval is based on two phase 3 clinical trials: GATHER1 (NCT02686658) and GATHER2 (NCT04435366).
Both trials measured the safety and efficacy of 2 mg of then-ACP administered intravitreally on a monthly basis for 12 months in a combined 733 patients with GA secondary to AMD.
And its performance?
ACP met its primary endpoint in both trials. Primary efficacy endpoints were based on GA area measured by fundus autofluorescence (FAF) at three timepoints: baseline, 6 months, and 12 months.
The mean rate of growth in the GA area from baseline to month 12, based on data, was 35% in GATHER1 and 18% in GATHER2.
See here for additional data.
What else?
The formulation was also found to slow the loss of photoreceptors and GA progression as early as 6 months.
Any adverse events reported?
Between both trials, the most common adverse reactions included:
- Conjunctival hemorrhage (13%)
- Increased intraocular pressure (IOP) (9%)
- Blurred vision (8%)
- Neovascular AMD (nAMD) (7%)
What makes it unique?
Prior to approval, the formulation was the only investigational candidate for GA treatment that had achieved its primary efficacy endpoint as well as the only such therapy to receive the FDA’s Breakthrough Therapy designation.
To note, Iveric Bio submitted two parts to its new drug application for ACP/Zimura; the August 4, 2023, FDA approval is also ahead of the previously scheduled Prescription Drug User Fee Act (PDUFA) date of August 19, 2023.
Significance?
IZERVAY is now the only approved GA treatment with a statistically significant reduction in the rate of GA progression at the 12-month primary endpoint, according to Astellas Pharma.
When will it be available?
Per a company news release, IZERVAY is expected to be available across the United States within 2 to 4 weeks.