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Safety of Intravitreal Pegcetacoplan for Geographic Atrophy (GA): 18-Month Results from the DERBY and OAKS trials
July 14, 2022 at 05:14 pm
Safety of Intravitreal Pegcetacoplan for Geographic Atrophy (GA): 18-Month Results from the DERBY and OAKS trials
Caroline Baumal , Allen Ho, Jordi Mones, Preeti Joshi, Caleb Bliss, Ravi Metlapally, Jeffrey Heier
July 13-16, 2022
40th Annual Meeting of the American Society of Retina Specialists, NY, USA
Disclosures
Studies funded by Apellis Pharmaceuticals
Phase 2 FILLY trial: New-onset study eye eAMD
Proportion of patientsdeveloping
Investigator-diagnosed eAMD
50%
through Month 18
40%
30%
20.9%
20%
8.9%
10%
1.2%
0%
PM
PEOM
Sham
(18/86)
(7/79)
(1/81)
An unexpected, dose-dependent difference in Investigator-determined study eye eAMD
Associated with greater probability of eAMD development:
Fellow eye eAMD
DLS on SD-OCT
patients with clinical
fellow eye eAMD
Proportion of
history of
80%
69%
70%
Double-layer sign at baseline
60%
37%
50%
Overall
89
153
33%
40%
33%
No eAMD
70
146
30%
73%
20%
eAMD
19
7
10%
0%
20%
40%
60%
80%
100%
0%
Eyes with eAMD
Eyes with no eAMD
DLS present
DLS absent
(18/26)
(72/217)
AMD=age-related macular degeneration; DLS=double-layer sign; eAMD=exudative AMD; PEOM=pegcetacoplan every other month; PM=pegcetacoplan monthly;
SD-OCT=spectral domain optical coherence tomography. Wykoff CC et al. Ophthalmology 2021;128:1325-36.
FILLY post hoc analysis of CNV detected on FA at time of eAMD report
Fluorescein angiography:
Acquired in 17/26 (65%) eyes at the time of eAMD diagnosis
10 eyes had detectable CNV
All categorized as occult
7 eyes had no detectable CNV
Images graded by DARC.
CNV=choroidal neovascularization; DARC=Digital Angiography Reading Center; eAMD=exudative age-related macular degeneration; FA=fluorescein angiography. Wykoff CC et al. Ophthalmology 2021;128:1325-36.
eAMD findings from FILLY informed the design of the Phase 3 program
If eAMD is suspected, prespecified imaging (CFP, OCT, FA and OCTA [select sites]) is captured
Once eAMD is verified by masked reading center, patients remain on study treatment and should also be treated with on-labelanti-VEGF pharmacotherapy
Initiation of anti-VEGF therapy for eAMD is at the discretion of the Investigator and is not reading-center determined
Within the reporting from DERBY and OAKS
Reports of eAMD include all AEs reported by the Investigator falling within the preferred terms neovascular AMD or CNV
AE=adverse event; AMD=age-related macular degeneration; CFP=color fundus photography; CNV=choroidal neovascularization; eAMD=exudative AMD; FA=fluorescein angiography;
5
OCT=optical coherence tomography; OCTA=OCT angiography; VEGF=vascular endothelial growth factor.
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Apellis Pharmaceuticals Inc. published this content on 14 July 2022 and is solely responsible for the information contained therein. Distributed by Public , unedited and unaltered, on 14 July 2022 16:13:07 UTC .
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Apellis Pharmaceuticals, Inc. is a commercial-stage biopharmaceutical company. The Company is focused on the discovery, development and commercialization of novel therapeutic compounds to treat diseases with high unmet needs through the inhibition of the complement system. SYFOVRE (pegcetacoplan injection) is the Companyâs approved treatment for geographic atrophy secondary to age-related macular degeneration (GA). Its EMPAVELI (pegcetacoplan), is for the treatment of paroxysmal nocturnal hemoglobinuria (PNH). Its Aspaveli (pegcetacoplan) for the treatment of adults with PNH who are anemic after treatment with a C5 inhibitor for at least three months. Systemic pegcetacoplan has also been approved for the treatment of PNH in Japan, Saudi Arabia, Australia, the United Kingdom and other jurisdictions. Systemic pegcetacoplan is marketed under the trade name EMPAVELI in the United States, Saudi Arabia and Australia and Aspaveli in the European Union, Japan and United Kingdom.
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