Izervay slows geographic atrophy growth at 24 months
Click Here to Manage Email Alerts
Key takeaways:
- Izervay significantly slowed geographic atrophy growth compared with sham at 24 months.
- Safety results at 24 months were consistent with those reported at 12 months.
Izervay met its primary objective of slowing geographic atrophy growth compared with sham at 24 months in the phase 3 GATHER2 clinical trial, according to a press release from Astellas Pharma.
The topline results showed that Izervay (avacincaptad pegol intravitreal solution), a complement C5 inhibitor, significantly slowed geographic atrophy (GA) growth when delivered in a monthly dosing regimen compared with sham. It also showed a similar reduction when dosed every other month.
The safety profile was consistent with previously reported 12-month data, with one case of culture-positive endophthalmitis and one case of nonserious intraocular inflammation.
“There were no cases of occlusive or non-occlusive retinal vasculitis or ischemic neuropathy,” the release said. “The rate of choroidal neovascularization was 12% in patients treated with Izervay and 9% in those treated with sham.”
Izervay received FDA approval for the treatment of GA secondary to age-related macular degeneration in August, and it is currently under review by the European Medicines Agency.
Perspective
Back to Top
Izervay (avacincaptad pegol intravitreal solution, Iveric Bio), a complement C5 inhibitor, was approved by the FDA on Aug. 4 for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration. The approval was granted due to the notable reduction in GA growth observed in patients treated with Izervay at 12 months in both the GATHER1 and GATHER2 phase 3 trials, and it is presently undergoing evaluation by the European Medicines Agency.
The recent announcement from Astellas Pharma regarding the phase 3 GATHER2 clinical trial results for Izervay at 24 months is undoubtedly encouraging news for patients dealing with GA secondary to AMD and for the entire retina community.The fact that the monthly dosing regimen of Izervay successfully slowed GA growth compared with the sham group at the 24-month mark is a significant step forward in the battle against this debilitating condition. Equally promising is the observation that the every other month dosing regimen showed a similar positive impact.
When it comes to safety, the consistency in data over 24 months, with no new safety concerns emerging, is reassuring. However, we must remain vigilant and continue monitoring the long-term effects of Izervay.
These topline results are promising, and we eagerly anticipate more detailed data presentations and in-depth scientific discussion at forthcoming retina conferences. This ongoing and exciting journey toward finding effective treatments for GA now boasts two approved therapies, and these results represent a significant stride in the right direction.
Read more about
Click Here to Manage Email Alerts