FDA approves expanded label for Izervay
Key takeaways:
- Izervay is now approved without limitation on duration of dosing.
- The approval is based on data from the phase 3 GATHER2 trial.
The FDA approved expanded prescribing information for Izervay for the treatment of geographic atrophy secondary to age-related macular degeneration, according to a press release from Astellas Pharma.
Izervay (avacincaptad pegol intravitreal solution) is now approved without a limitation on duration of dosing, which provides greater flexibility for patients and physicians, the release said.
The label update follows the company’s supplemental new drug application resubmission in December 2024, based on the results of the phase 3 GATHER2 trial, according to the release. The FDA approved Izervay in August 2023.
Through 2 years, the GATHER2 trial demonstrated that Izervay helped reduce the rate of GA lesion growth compared with sham. Patients in the treatment arm saw a benefit starting as early as 6 months, and the benefit increased through 2 years, according to the release.
There was one case each of nonserious intraocular inflammation and culture-positive endophthalmitis. There were no cases of ischemic neuropathy or serious intraocular inflammation, but the rate of choroidal neovascularization was higher in patients treated with Izervay (11.6%) vs. sham (9%) at 2 years.
“We are pleased with the FDA’s decision to extend the use of Izervay for longer-term administration — further solidifying Izervay’s status as a trusted choice for thousands of GA patients since its launch in 2023,” Marci English, senior vice president of biopharma and ophthalmology development at Astellas, said in the release. “To date, Izervay remains the only FDA-approved treatment to demonstrate a statistically significant slowing of GA across two pivotal studies.”