- New 30-month data from the GALE long-term extension study of SYFOVRE® (pegcetacoplan injection) to be presented
WALTHAM, Mass., July 10, 2023 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. (Nasdaq: APLS) announced that seven abstracts will be presented as oral presentations at the American Society of Retina Specialists (ASRS) Annual Scientific Meeting to be held July 28 to August 1 in Seattle. The upcoming data further reinforces the efficacy and safety profile of SYFOVRE® (pegcetacoplan injection), the first and only treatment for geographic atrophy (GA) secondary to age-related macular degeneration (AMD).
“The breadth of SYFOVRE data at ASRS is a testament to the excitement surrounding the first and only FDA approved treatment for GA, which provides flexible dosing and slows GA lesion growth with increasing treatment effects over time,” said Caroline Baumal, MD, chief medical officer, Apellis. “Among our seven oral presentations this year, we are thrilled to present data for the first time from the GALE long-term extension study of SYFOVRE.”
Presentations include:
- Long-Term Efficacy of Pegcetacoplan in Patients with Geographic Atrophy – Nathan Steinle, MD – Dry AMD Symposium 2 – Sunday, July 30 – 9:06-9:12 a.m. PT
- Effect of Pegcetacoplan on Photoreceptor and Retinal Pigment Epithelium Integrity in Geographic Atrophy in the Phase 3 Trials and GALE Extension Study – Ursula Schmidt-Erfurth, MD – Dry AMD Symposium 2 – Sunday, July 30 – 9:12-9:18 a.m. PT
- Retinal Tissue Preservation with Intravitreal Pegcetacoplan in Patients with Geographic Atrophy – Sunir Garg, MD – Dry AMD Symposium 2 – Sunday, July 30 – 9:18-9:22 a.m. PT
- Pegcetacoplan vs Avacincaptad Pegol in Patients with Geographic Atrophy: An Anchored Matching-Adjusted Indirect Comparison of the Phase 3 Trials – Paul Hahn, MD – Dry AMD Symposium 2 – Sunday, July 30 – 9:42-9:46 a.m. PT
- The MOSAIC Study: A Clinical and Humanistic Burden of Illness Study of Patients with Geographic Atrophy and their Caregivers in the United States and Canada – Sophie J. Bakri, MD – Dry AMD Symposium 1 – Saturday, July 29 – 9:15-9:19 a.m. PT
- Utility of Outer Retinal Tubulation in Predicting Lesion Growth in Both Subfoveal and Nonsubfoveal Geographic Atrophy – Srinivas Kondapalli, MD – Imaging, Digital, Angiography Symposium – Saturday, July 29 – 2:57-3:01 p.m. PT
- Exudative Age-Related Macular Degeneration Events from the OAKS and DERBY Clinical Trials of Pegcetacoplan in Geographic Atrophy – Roger Goldberg, MD – Wet AMD Symposium 3 – Monday, July 31 – 1:05-1:09 p.m. PT
About GALE
GALE is a Phase 3, multicenter, open label, extension study to evaluate the long-term safety and efficacy of SYFOVRE® (pegcetacoplan injection) in patients with geographic atrophy (GA) secondary to age-related macular degeneration (AMD). The objectives of the study are to evaluate the long-term incidence and severity of ocular and systemic treatment emergent adverse events as well as change in the total area of GA lesions as measured by fundus autofluorescence. More than 80 percent of participants who completed the OAKS and DERBY studies entered the GALE study.
About the Phase 3 OAKS and DERBY Studies
OAKS (n=637) and DERBY (n=621) are Phase 3, multicenter, randomized, double-masked, sham-controlled studies comparing the efficacy and safety of SYFOVRE® (pegcetacoplan injection) with sham injections across a broad and heterogenous population of patients with geographic atrophy (GA) secondary to age-related macular degeneration (AMD). The studies evaluated the efficacy of monthly and every-other-month SYFOVRE in patients with GA assessed by change in the total area of GA lesions from baseline as measured by fundus autofluorescence. In Phase 3 studies at 24 months, both every-other-month and monthly SYFOVRE reduced GA lesion growth with increasing effects over time and showed a well-demonstrated safety profile.
About Geographic Atrophy (GA)
Geographic atrophy (GA) is an advanced form of age-related macular degeneration and a leading cause of blindness worldwide, impacting more than one million Americans and five million people worldwide.1,2 It is a progressive and irreversible disease caused by the growth of lesions, which destroy the retinal cells responsible for vision. The vision loss caused by GA severely impairs independence and quality of life by making it difficult to participate in daily activities. On average, it takes only 2.5 years for GA lesions to start impacting the fovea, which is responsible for central vision.3
About SYFOVRE® (pegcetacoplan injection)
SYFOVRE® (pegcetacoplan injection) is the first and only approved therapy for geographic atrophy (GA). By targeting C3, SYFOVRE is designed to provide comprehensive control of the complement cascade, part of the body’s immune system. SYFOVRE is approved in the United States for the treatment of GA secondary to age-related macular degeneration.
U.S. Important Safety Information for SYFOVRE® (pegcetacoplan injection)
CONTRAINDICATIONS
- SYFOVRE is contraindicated in patients with ocular or periocular infections, and in patients with active intraocular inflammation
WARNINGS AND PRECAUTIONS
- Endophthalmitis and Retinal Detachments
- Intravitreal injections, including those with SYFOVRE, may be associated with endophthalmitis and retinal detachments. Proper aseptic injection technique must always be used when administering SYFOVRE to minimize the risk of endophthalmitis. Patients should be instructed to report any symptoms suggestive of endophthalmitis or retinal detachment without delay and should be managed appropriately.
- Neovascular AMD
- In clinical trials, use of SYFOVRE was associated with increased rates of neovascular (wet) AMD or choroidal neovascularization (12% when administered monthly, 7% when administered every other month and 3% in the control group) by Month 24. Patients receiving SYFOVRE should be monitored for signs of neovascular AMD. In case anti-Vascular Endothelial Growth Factor (anti-VEGF) is required, it should be given separately from SYFOVRE administration.
- Intraocular Inflammation
- In clinical trials, use of SYFOVRE was associated with episodes of intraocular inflammation including: vitritis, vitreal cells, iridocyclitis, uveitis, anterior chamber cells, iritis, and anterior chamber flare. After inflammation resolves, patients may resume treatment with SYFOVRE.
- Increased Intraocular Pressure
- Acute increase in IOP may occur within minutes of any intravitreal injection, including with SYFOVRE. Perfusion of the optic nerve head should be monitored following the injection and managed as needed.
ADVERSE REACTIONS
- Most common adverse reactions (incidence ≥5%) are ocular discomfort, neovascular age-related macular degeneration, vitreous floaters, conjunctival hemorrhage.
Please see accompanying full Prescribing Information for more information.
About Apellis
Apellis Pharmaceuticals, Inc. is a global biopharmaceutical company that combines courageous science and compassion to develop life-changing therapies for some of the most challenging diseases patients face. We ushered in the first new class of complement medicine in 15 years and now have two approved medicines targeting C3. These include the first and only therapy for geographic atrophy, a leading cause of blindness around the world. With nearly a dozen clinical and pre-clinical programs underway, we believe we have only begun to unlock the potential of targeting C3 across many serious diseases. For more information, please visit http://apellis.com or follow us on Twitter and LinkedIn.
Apellis Forward-Looking Statement
Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements” within the meaning of The Private Securities Litigation Reform Act of 1995. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including whether clinical trials of SYFOVRE or the data analyses reported in this release indicate an apparent positive effect that is greater than the actual positive effect, and other factors discussed in the “Risk Factors” section of Apellis’ Annual Report on Form 10-K with the Securities and Exchange Commission on February 21, 2023 and the risks described in other filings that Apellis may make with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Apellis specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.
Media Contact:
Lissa Pavluk
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617.977.6764
Investor Contact:
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617.599.8178
1Rudnicka AR, Jarrar Z, Wormald R, et al. Age and gender variations in age-related macular degeneration prevalence in populations of European ancestry: a meta analysis. Ophthalmology 2012;119:571–580.
2Wong WL, Su X, Li X, et al. Global prevalence of age-related macular degeneration and disease burden projection for 2020 and 2040: a systematic review and meta-analysis. Lancet Glob Health 2014;2:e106–116.
3 Lindblad AS, et al, and AREDS Research Group. Arch Ophthalmol. 2009;127(9):1168-1174.
