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Safety of intravitreal pegcetacoplan in geographic atrophy: results from the DERBY and OAKS trials
September 30, 2021 at 12:02 pm
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
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 .
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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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