Geographic Atrophy

Chief among a flurry of clinical advances in retina disease this year were the FDA approvals of complement inhibitors for GA and a higher-dose aflibercept for diabetic retinopathy. What comes next?

David Lally, MD, discusses biomarkers for the progression of geographic atrophy and the lack of previous treatment options for the disease.

Veeral Sheth, MD, MBA describes the presentation of geographic atrophy in patients and how they are first affected by the disease.

David Lally, MD describes the hallmark features of geographic atrophy and how the disease develops over time.

Phase 3 results from the GATHER2 trial show the treatment effect of avacincaptad pegol for geographic atrophy more than doubled over 2 years compared to year 1 of study.

Presented at AAO 2023, new 3-year data from the GALE extension study shows increasing treatment effects over time with pegcetacoplan injection for geographic atrophy.

ARCHER study demonstrated that the antibody ANX007 was time and dose dependent, robust, and not dependent on lesion growth.

Without treatment, lesions > 500 µm away from the fovea will take anywhere from 3.07 years to 12.9 years to reach it. With pegcetacoplan treatment, the lesion will reach the fovea anywhere between 3.56 years – 15 years for monthly treatment and 3.47-14.6 years for treatment every other month.

For people with geographic atrophy, taking pegcetacoplan every other month (the EOM treatment) is more cost-effective than taking the medication every month (the EM treatment).

12-month GATHER2 results show monthly avacincaptad pegol 2 mg was well tolerated and showed significantly slower geographic atrophy growth than sham treatment.

An update from Apellis reports 10 confirmed events of retinal vasculitis and 2 suspected events associated with pegcetacoplan injection for geographic atrophy.

In a recent case series, a substantial percentage of patients with GA experienced "floaters" from presumed intravitreal silicone oil droplets after pegcetacoplan injection.

Our ophthalmology month in review for September 2023 highlights our top stories in retina, the latest news from the FDA, and insights into the evolving specialty landscape.

The analysis reports clinical characteristics and the GA progression rate in an Asian population differ from those previously reported in White populations.

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Announced by Iveric Bio, topline results from the phase 3 GATHER2 clinical trial indicate monthly avacincaptad pegol significantly slowed GA growth compared to sham at 24 months.

A post hoc analysis of the PREVENT trial suggests quarterly ranibizumab did not appear to affect drusen volume, drusen area, or GA progression compared to sham.

The analysis found any metformin use decreased the odds of developing dry AMD, particularly cumulative 2-year doses of 1 to 270 g and 271 to 600 g.

Apellis Pharmaceuticals identified internal structural variations in the 19-gauge filter needle included in certain injection kits for pegcetacoplan injection, the first FDA-approved treatment for geographic atrophy.

Each month, our editorial staff compiles a recap of the top news in ophthalmology from the past month. Our July 2023 month-in-review features a recap of conference coverage from the ASRS 41st Annual Scientific Meeting.

Last week's FDA approval of avacincaptad pegol marked the second approved treatment for geographic atrophy in 2023. Here, 4 retina specialists discuss the complement inhibitor and what it could represent for patients with GA.

The approval is the second granted to a geographic atrophy drug that targets the complement pathway.

Presented at ASRS 2023, results from the GALE extension study showed crossover to pegcetacoplan treatment from sham stabilized photoreceptor degeneration over 6 months.

Reports of a half-dozen confirmed cases of the rare vision-threatening condition has spurred conversation around the first-in-class geographic atrophy drug.

Presented at ASRS 2023, pegcetacoplan injection showed increasing treatment effects over 30 months for patients with geographic atrophy, with a consistent safety profile to previous phase 3 data.

Low vision rehabilitation was associated with statistically significant increases in the overall composite score of a vision-related quality of life scale.

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At ARVO 2023, 24-month data suggests the change from baseline in GA lesion growth consistently favored pegcetacoplan vs. sham across subgroups in DERBY and OAKS trials.

In an interview at ARVO 2023, Danzig discusses the post-hoc analysis from the GATHER trials, showing that a reduced rate of vision loss in patients receiving avacincaptad pegol was correlated with reduced GA growth.