Apellis Announces 11 Oral Presentations at the Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting

Rhea-AI Summary

Apellis Pharmaceuticals, Inc. announced 11 oral presentations at the ARVO Annual Meeting, showcasing the efficacy and safety profile of SYFOVRE® for geographic atrophy secondary to AMD. The data presented highlight the potential of SYFOVRE to slow disease progression and preserve visual function over time.

Positive

• The 11 oral presentations at ARVO demonstrate ongoing excitement around SYFOVRE as the preferred GA treatment by retina specialists.

• Data presented confirm SYFOVRE's ability to slow disease progression and preserve visual function over time.

Negative

• Increased rates of neovascular AMD were associated with the use of SYFOVRE in clinical trials, indicating a potential risk of developing wet AMD.

• Safety concerns include endophthalmitis, retinal detachments, retinal vasculitis, retinal vascular occlusion, and intraocular inflammation when using SYFOVRE.

WALTHAM, Mass., May 01, 2024 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. (Nasdaq: APLS) today announced that 14 abstracts, 11 of which are oral presentations, will be presented at the Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting to be held May 5 - 9 in Seattle. The data continue to reinforce the robust efficacy and safety profile of SYFOVRE^® (pegcetacoplan injection) for geographic atrophy (GA) secondary to age-related macular degeneration (AMD).

“The 11 oral presentations at ARVO speak to the continued excitement surrounding SYFOVRE, which is the most chosen GA treatment by retina specialists,” said Caroline Baumal, M.D., chief medical officer, Apellis. “We are excited to share data that continue to highlight SYFOVRE’s ability to slow disease progression with increasing effects over time and its potential to preserve visual function longer.”

Oral presentations:

• Long-term efficacy and safety of pegcetacoplan over 36 months: results from 12 months of the GALE open-label extension study – Ashkan Abbey, M.D. – Sunday, May 5 – 1:45‑2:00 PM PDT (encore)
  
• Pegcetacoplan vs avacincaptad pegol in geographic atrophy: an anchored matching-adjusted indirect comparison of three phase 3 trials – Marco Zarbin, M.D., Ph.D. – Thursday, May 9 – 2:15‑2:30 PM PDT (encore)
  
• Pegcetacoplan delays time to loss of central macular sensitivity: a microperimetry analysis of the phase 3 OAKS study – Rishi Singh, M.D., FASRS – Thursday, May 9 – 3:30‑3:45 PM PDT (encore)
  
• The SD-OCT correlates of fundus autofluorescence in geographic atrophy: a comprehensive point-to-point analysis of fundus autofluorescence with SD-OCT using phase 3 trials DERBY and OAKS – Konstantinos Balaskas, M.D. – Sunday, May 5 – 2:15‑2:30 PM PDT
  
• Variability of perilesional FAF patterns associated with automated OCT-based PR/RPE loss ratios in GA progression in the phase 3 OAKS/DERBY trials – Julia Mai, M.D. – Sunday, May 5 – 4:45‑5:00 PM PDT
  
• Contrast sensitivity function using a prototype gaze tracking-based virtual reality headset in age-related macular degeneration (AMD) – Deepayan Kar, Ph.D., MS – Monday, May 6 – 8:30‑8:45 AM PDT
  
• A deep-learning approach to identifying quantitative OCT biomarkers predictive of visual deficit measured by microperimetry at 24 months in OAKS trial – Dun Jack Fu, Ph.D., BMBCh – Tuesday, May 7 – 9:30‑9:45 AM PDT
  
• AI-based qOCT analysis of phase 3 trials OAKS & DERBY data on the effect of pegcetacoplan on geographic atrophy – Pallavi Bagga, Ph.D. – Tuesday, May 7 – 2:15‑2:30 PM PDT
  
• Predictive value of the photoreceptor/RPE loss ratio on OCT in the management of geographic atrophy (GA) for patient selection and monitoring of therapeutic efficacy – Ursula Schmidt‑Erfurth, M.D. – Tuesday, May 7 – 2:30‑2:45 PM PDT
  
• Rate of response to treatment in eyes with geographic atrophy treated with Pegcetacoplan in a within-patient comparison using automated AI-based OCT biomarker quantifications in OAKS, DERBY and GALE – Gregor S. Reiter, M.D., Ph.D. – Thursday, May 9 – 2:30‑2:45 PM PDT
  
• IRIS^® Registry analysis of anti-VEGF treatment in patients with coexisting neovascular age-related macular degeneration and geographic atrophy – Theodore Leng, M.D., FACS – Thursday, May 9 – 3:15‑3:30 PM PDT
  

Poster presentations:

• Prevalence of outer retinal tubulation (ORT) and association with geographic atrophy (GA) growth among patients in the OAKS and DERBY trials – Kensington Hatcher, O.D., FAAO – Monday, May 6 – 3:00‑4:45 PM PDT
  
• Loss of independence in geographic atrophy (GA) - results from the MOSAIC study among patients and caregivers in Europe – Beverly Lui, PharmD – Thursday, May 9 – 8:00‑9:45 AM PDT
  
• Deep learning-based segmentation of geographic atrophy in fundus autofluorescence: external validation in imaging acquired in a clinical trial – Souvick Mukherjee, Ph.D. – Thursday, May 9 – 8:00‑9:45 AM PDT
  

About SYFOVRE^® (pegcetacoplan injection)
SYFOVRE^® (pegcetacoplan injection) is the first-ever 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.

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

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.
• Retinal Vasculitis and/or Retinal Vascular Occlusion
  • Retinal vasculitis and/or retinal vascular occlusion, typically in the presence of intraocular inflammation, have been reported with the use of SYFOVRE. Cases may occur with the first dose of SYFOVRE and may result in severe vision loss. Discontinue treatment with SYFOVRE in patients who develop these events. Patients should be instructed to report any change in vision without delay.
• 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-ever therapy for geographic atrophy, a leading cause of blindness around the world. We believe we have only begun to unlock the potential of targeting C3 across serious retinal, rare, and neurological 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 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 27, 2024 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 
media@apellis.com  
617.977.6764

Investor Contact: 
Meredith Kaya 
meredith.kaya@apellis.com
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.
³Lindblad AS, et al, and AREDS Research Group. Arch Ophthalmol. 2009;127(9):1168-1174.

FAQ

<p>What is the focus of the Apellis Pharmaceuticals PR?</p>

The PR highlights 11 oral presentations at the ARVO Annual Meeting regarding SYFOVRE®, a treatment for geographic atrophy secondary to AMD.

<p>What is the purpose of SYFOVRE?</p>

SYFOVRE is designed to provide comprehensive control of the complement cascade, targeting C3, and is the first-ever approved therapy for geographic atrophy.

<p>What are the safety concerns associated with SYFOVRE?</p>

Safety concerns include endophthalmitis, retinal detachments, retinal vasculitis, retinal vascular occlusion, and intraocular inflammation.

<p>What is geographic atrophy (GA)?</p>

GA is an advanced form of age-related macular degeneration, leading to vision loss due to retinal cell destruction.

<p>How many oral presentations will Apellis have at the ARVO Annual Meeting?</p>

Apellis will have 11 oral presentations at the ARVO Annual Meeting.