Apellis Announces Late-Breaking Presentation of Largest Retrospective Database Study in Geographic Atrophy at AAO 2020 Virtual

Apellis Pharmaceuticals announced findings from a large retrospective database study in geographic atrophy (GA) secondary to age-related macular degeneration (AMD). The analysis of the American Academy of Ophthalmology IRIS (Intelligent Research in Sight) Registry was conducted in partnership with Verana Health. The study highlights the impact of GA progression on vision, underscoring the high unmet need for GA treatment in clinical practice. The data were presented today in a late-breaking oral session as part of the Retina Subspecialty Day at AAO 2020 Virtual.

The retrospective study included more than 69,000 patients diagnosed with GA and analyzed changes in visual acuity and disease progression for over 2 years, as well as the occurrence of concurrent wet AMD.

“There is no approved therapy for GA and with new agents under development, it is essential to have a detailed understanding of disease progression in real-world clinical practice,” Ehsan Rahimy, MD, lead study author and surgical and medical vitreoretinal specialist at the Palo Alto Medical Foundation, said in a company news release. “The data show that GA patients at their first encounter have useful vision that may be preserved if an effective treatment were available. The progressive loss of visual acuity observed in this study over a two-year period underscores the urgent need for a therapy to slow disease progression.” 

Key findings from the real-world clinical data show: 

• Progression from GA to new onset wet AMD was observed in 4.7% of patients with bilateral GA (GA in both eyes) and 13.3% of patients with wet AMD in the contralateral eye during the first 12 months. The rate at 24 months was 8.2% and 21.6% in bilateral GA and wet AMD in the contralateral eye, respectively.
• At the first study visit, patients presented with relatively preserved vision, especially in eyes with extrafoveal GA lesions (lesions outside the fovea, which is the central portion of the retina). However, patients with extrafoveal and foveal GA lesions progressively lost vision over time at a rate of approximately five letters per year. 
• A large proportion of GA patients did not return for a follow-up visit after 2 years. Of the GA patients potentially eligible for inclusion in the analysis, only 40% had a follow-up visit after two years and were ultimately included in the study.

“As we work to develop the first potential medicine for people with GA, we are committed to improving understanding of the disease. Our collaboration with Verana Health and the AAO IRIS Registry shows that wet AMD is not a rare occurrence in GA patients, and there is an opportunity to preserve vision if new treatments become available,” Federico Grossi, MD, PhD, chief medical officer of Apellis, said in a company news release. “These results highlight the significant unmet need in GA, and we are working urgently to advance pegcetacoplan, a targeted C3 therapy, in two ongoing Phase 3 GA studies.”