C3 inhibitor may prevent progression from nascent to manifest geographic atrophy
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A post hoc analysis of the phase 2 FILLY study demonstrated that patients who received multiple intravitreal injections of pegcetacoplan had a lower rate of progression from nascent geographic atrophy to GA as compared with sham.
“We were able to demonstrate that complement C3 inhibitor pegcetacoplan impacts the progression of nascent geographic atrophy, providing evidence to further explore the potential for an earlier intervention,” SriniVas Sadda, MD, said at the virtual Euretina congress.
Most therapeutic trials, such as FILLY, focus on the end stage of GA, trying to prevent further progression of atrophy after it is already present. This further analysis applied the OCT-based criteria of the Classification of Atrophy Meetings program to study the conversion from incomplete retinal pigment epithelium (RPE) and outer retinal atrophy (iRORA), or nascent GA, to complete RPE and outer retinal atrophy (cRORA), or GA, in patients treated with pegcetacoplan (APL-2, Apellis Pharmaceuticals) vs. sham in the FILLY trial. Previous studies have shown that in the natural history of the disease, iRORA lesions have a 90% probability to progress to cRORA by 24 months.
“We included subjects who received the monthly treatment through month 12 and did not develop exudative AMD and compared them to the sham patients. Masked readers at the reading center assessed the OCT outside a 500 µm perimeter from the GA border at baseline, 6 and 12 months. We specifically looked for two types of progression, from iRORA to cRORA and from large drusen to iRORA and/or cRORA,” Sadda said.
A significant 39% reduction of progression from iRORA to cRORA was observed in the pegcetacoplan-treated patients as compared with the sham group. Overall, the sham group was 1.64 times more likely to progress to cRORA.
“In addition, if you look at the progression from large drusen within 12 months, there were relatively fewer progression events overall. The trend suggested continued progression in the sham group after month 6 but not in the pegcetacoplan group,” Sadda said.
Further data to confirm these findings will be collected in the DERBY and OAK global phase 3 studies.
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Sadda S. Impact of pegcetacoplan on progression of nascent geographic atrophy in AMD. Presented at: Euretina congress; Oct. 2-4, 2020 (virtual meeting).
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