Safety of intravitreal pegcetacoplan in geographic atrophy: results from the DERBY and OAKS trials

Charles Wykoff, Jeffrey Heier, Rishi Singh, Nathan Steinle, David Boyer, Jordi Monés, Giovanni Staurenghi, Frank G. Holz, Caleb Bliss, Pascal Deschatelets, Federico Grossi, Cedric Francois, Ramiro Ribeiro

30 September 2021

Retina Society 2021, Chicago, USA

Disclosures

  • Dr. Wykoff has the following Disclosures:
    • Consulting: AbbVie, Adverum, Aerie Pharmaceuticals, Allergan, Allgenesis, Alnylam, Annexon, Apellis, Arrowhead Pharmaceuticals, Bausch + Lomb, Bayer, Bionic Vision Technologies, Chengdu Kanghong Biotechnologies (KHB), Clearside Biomedical, EyePoint Pharmaceuticals, Genentech, Gyroscope, IVERIC Bio, Janssen, Kato Pharmaceuticals, Kodiak Sciences, Long Bridge Medical, NGM Biopharmaceuticals, Novartis, OccuRx, Ocular Therapeutix, ONL Therapeutics, Opthea Limited, Palatin, Perfuse Therapeutics, PolyPhotonix, RecensMedical, Regeneron, RegenXBio, Roche, Surrozen, Takeda, Valo, Verana Health, Vitranu
    • Research: Adverum, Aerie Pharmaceuticals, Aldeyra, Alimera Sciences, Alkahest, Allergan, Amgen, Annexon, Apellis, Asclepix, Bayer, Boehringer Ingelheim, Chengdu Kanghong Biotechnology, Clearside Biomedical, Gemini, Genentech, Graybug Vision, Gyroscope, IONIS Pharmaceutical, iRENIX, IVERIC bio, Kodiak Sciences, LMRI, Nanoscope, Neurotech Pharmaceuticals, NGM Biopharmaceuticals, Novartis, Ocular Therapeutix, Opthea, Oxurion, RecensMedical, Regeneron, RegenXBio, Roche, SamChunDang Pharm, Taiwan Liposome Company, Xbrane BioPharma
    • Ownership/Stock: ONL Therapeutics, PolyPhotonix, RecensMedical, Visgenx
  • Study funded by Apellis Pharmaceuticals

Outline

  • Patient Disposition and Drug Exposure
  • Overall AEs and SAEs
  • Cases of Intraocular Inflammation
  • Cases of Infectious Endophthalmitis
  • Cases of Exudative AMD

AMD=age-related macular degeneration; AE=adverse event; SAE=serious AE.

Patient Disposition

Patient disposition

OAKS

DERBY

PM

PEOM

Sham

PM

PEOM

Sham

Pooled

Pooled

(N=213)

(N=212)

(N=206)

(N=208)

(N=212)

(N=207)

Completed study through

184 (86.4%)

190 (89.6%)

191 (90.1%)

183 (88.8%)

188 (90.4%)

179 (86.5%)

Month 12, n (%)

Discontinued study prior

29

(13.6%)

22

(10.4%)

21 (9.9%)

23 (11.2%)

20 (9.6%)

28 (13.5%)

to Month 12, n (%)

Reason for discontinuation

Consent withdrawal

14 (6.6%)

11 (5.2%)

9 (4.2%)

15 (7.3%)

10 (4.8%)

15 (7.2%)

Death

7

(3.3%)

3

(1.4%)

4 (1.9%)

5 (2.4%)

0

3 (1.4%)

Adverse event

3 (1.4%)

5 (2.4%)

2 (0.9%)

1 (0.5%)

4 (1.9%)

5 (2.4%)

COVID-19 impact

3

(1.4%)

2

(0.9%)

5 (2.4%)

1 (0.5%)

6 (2.9%)

5 (2.4%)

Lost to follow-up

2

(0.9%)

1

(0.5%)

1 (0.5%)

1 (0.5%)

0

0

N=number of patients; PM=pegcetacoplan monthly; PEOM=pegcetacoplan every other month.

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Apellis Pharmaceuticals Inc. published this content on 30 September 2021 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 30 September 2021 16:01:02 UTC.