Safety of Intravitreal Pegcetacoplan for Geographic Atrophy (GA): 18-Month Results from the DERBY and OAKS trials

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

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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 allAEs 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.