{"id":690634,"date":"2022-09-30T07:03:11","date_gmt":"2022-09-30T11:03:11","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/apellis-announces-four-oral-presentations-of-data-from-the-phase-3-derby-and-oaks-studies-of-pegcetacoplan-in-geographic-atrophy-ga-to-be-presented-at-the-american-academy-of-ophthalmology-annual-me\/"},"modified":"2022-09-30T07:03:11","modified_gmt":"2022-09-30T11:03:11","slug":"apellis-announces-four-oral-presentations-of-data-from-the-phase-3-derby-and-oaks-studies-of-pegcetacoplan-in-geographic-atrophy-ga-to-be-presented-at-the-american-academy-of-ophthalmology-annual-me","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/apellis-announces-four-oral-presentations-of-data-from-the-phase-3-derby-and-oaks-studies-of-pegcetacoplan-in-geographic-atrophy-ga-to-be-presented-at-the-american-academy-of-ophthalmology-annual-me\/","title":{"rendered":"Apellis Announces Four Oral Presentations of Data from the Phase 3 DERBY and OAKS Studies of Pegcetacoplan in Geographic Atrophy (GA) to be Presented at the American Academy of Ophthalmology Annual Meeting"},"content":{"rendered":"<div class=\"mw_release\">\n<p align=\"left\">WALTHAM, Mass., Sept.  30, 2022  (GLOBE NEWSWIRE) &#8212; Apellis Pharmaceuticals, Inc. (Nasdaq: APLS), a global biopharmaceutical company and leader in complement, today announced that four oral presentations of data from the Phase 3 DERBY and OAKS studies evaluating pegcetacoplan for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration will be presented at the American Academy of Ophthalmology (AAO) Annual Meeting on September 30 \u2013 October 3 in Chicago, Illinois. Data highlights include detailed 24-month results of safety and efficacy as well as exploratory analyses of lesion growth data and photoreceptor changes utilizing artificial intelligence guided image processing.<\/p>\n<p>\u201cOur scientific presence at AAO this year is a testament to our leadership in retina and the potential of pegcetacoplan to become the first treatment for GA, a devastating disease that leads to irreversible vision loss,\u201d said Federico Grossi, M.D., Ph.D., chief medical officer, Apellis. \u201cWe look forward to sharing these data with the ophthalmology community as we work toward bringing pegcetacoplan to patients with GA as quickly as possible.\u201d<\/p>\n<p>The U.S. marketing application for pegcetacoplan for GA is under Priority Review with a Prescription Drug User Fee Act (PDUFA) target action date of Nov. 26, 2022. Apellis plans to submit a marketing authorization application to the European Medicines Agency by the end of this year.<\/p>\n<p>Presentation details:<\/p>\n<ul>\n<li>Treatment of Geographic Atrophy Secondary to AMD With Pegcetacoplan: Two-Year Outcomes from the Randomized Phase 3 DERBY and OAKS Trials \u2013 <a href=\"https:\/\/aao.apprisor.org\/apsSession.cfm?id=RET10\" rel=\"nofollow noopener\" target=\"_blank\">RET10<\/a> \u2013 Friday, Sept. 30 \u2013 4:30 \u2013 4:36 p.m. CST<\/li>\n<li>The Role of AI-Guided OCT Imaging in Geographic Atrophy \u2013 <a href=\"https:\/\/aao.apprisor.org\/apsSession.cfm?id=RET19\" rel=\"nofollow noopener\" target=\"_blank\">RET19<\/a> \u2013 Saturday, Oct. 1 \u2013 3:13 \u2013 3:19 p.m. CST<\/li>\n<li>Efficacy of Intravitreal Pegcetacoplan in GA: 24-Month Results from the Phase 3 DERBY and OAKS Trials \u2013 <a href=\"https:\/\/aao.apprisor.org\/apsSession.cfm?id=PA024\" rel=\"nofollow noopener\" target=\"_blank\">PA024<\/a> \u2013 Sunday, Oct. 2, 8:12 \u2013 8:19 a.m. CST<\/li>\n<li>Safety of Intravitreal Pegcetacoplan in GA: 24-Month Results from the Phase 3 DERBY and OAKS Trials\u00a0\u2013 <a href=\"https:\/\/aao.apprisor.org\/apsSession.cfm?id=PA069\" rel=\"nofollow noopener\" target=\"_blank\">PA069<\/a> \u2013 Sunday, Oct. 2, 4:45 \u2013 4:52 p.m. CST<\/li>\n<\/ul>\n<p>e-Poster:<\/p>\n<ul>\n<li>Evaluation of Patients with GA Secondary to AMD: Analysis of the Academy IRIS<sup>\u00ae<\/sup> Registry\u00a0\u2013 <a href=\"https:\/\/aao.apprisor.org\/apsSession.cfm?id=PO427\" rel=\"nofollow noopener\" target=\"_blank\">PO427<\/a><\/li>\n<\/ul>\n<p>\n        <strong>About DERBY and OAKS<\/strong><br \/>\n        <br \/>DERBY (621 patients enrolled) and OAKS (637 patients enrolled) are Phase 3, multicenter, randomized, double-masked, sham-controlled studies comparing the efficacy and safety of intravitreal pegcetacoplan with sham injections in patients with geographic atrophy (GA) secondary to age-related macular degeneration (AMD). The primary objective of the studies is to evaluate the efficacy of pegcetacoplan in patients with GA assessed by change in the total area of GA lesions from baseline as measured by fundus autofluorescence (p-value less than .05) at 12 months. Patients in DERBY and OAKS received masked treatment for 24 months. All patients who completed the DERBY or OAKS studies were invited to participate in the GALE open-label extension study.<\/p>\n<p>\n        <strong>About Geographic Atrophy\u00a0(GA)<\/strong><br \/>\n        <br \/>Geographic atrophy (GA) is an advanced form of age-related macular degeneration (AMD) and a leading cause of blindness that impacts more than 5 million people worldwide, including one million people in the United States.<sup>1<\/sup><sup>,<\/sup><sup>2<\/sup> This progressive disease can severely impair visual function, independence, and quality of life as it takes on average 2.5 years for GA lesions to encroach the fovea, which is responsible for central vision.<sup>3<\/sup> GA is caused by destruction of retinal cells through irreversible lesion growth that is driven by excessive complement activation.<sup>4<\/sup>\u00a0C3 is the only target that can precisely control the complement cascade due to its central location. There are currently no\u00a0approved treatments for GA.<\/p>\n<p>\n        <strong>About Pegcetacoplan for Geographic Atrophy (GA)<\/strong><br \/>\n        <br \/>Pegcetacoplan is an investigational, targeted C3 therapy designed to regulate excessive activation of the complement cascade, part of the body\u2019s immune system, which can lead to the onset and progression of many serious diseases. Pegcetacoplan\u00a0was granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for\u00a0the treatment of geographic atrophy.<\/p>\n<p>\n        <strong>About Apellis<\/strong>\u00a0<br \/>Apellis Pharmaceuticals, Inc. is a global biopharmaceutical company that is committed to leveraging courageous science, creativity, and compassion to deliver life-changing therapies. Leaders in complement, we ushered in the first new class of complement medicine in 15 years with the approval of the first and only targeted C3 therapy. We are advancing this science to continually develop transformative medicines for people living with rare, retinal, and neurological diseases. For more information, please visit\u00a0<a href=\"https:\/\/www.globenewswire.com\/Tracker?data=Rz6i3s2xR-cAC86a9lGwm0jG0AYxDUPen2na2XPQUd2wkYpNCi1zeBY2uoL4G4Ztohdo9VxzSc8pl6wtN1xi4g==\" rel=\"nofollow noopener\" target=\"_blank\">http:\/\/apellis.com<\/a> or follow us on <a href=\"https:\/\/www.globenewswire.com\/Tracker?data=XWrLohY9awmft3Q6vtKifD12OewB_fKlXCxTUHtDJ-OtSrChqzpuRWy4kn9iTc1CK0Fnu1mlFCY2pWeWIeS35g==\" rel=\"nofollow noopener\" target=\"_blank\">Twitter<\/a> and <a href=\"https:\/\/www.globenewswire.com\/Tracker?data=EXxL7hp0HM2SheBYiJqMT60chXMD3Duc4TxwC0r2zTy9mUZcpCK6zx8oMeT-5hZvy6t4gOiFLLWrXSzd4-mzEsMOVAGg3AkxRlOmg48jgXo=\" rel=\"nofollow noopener\" target=\"_blank\">LinkedIn<\/a>.<\/p>\n<p>\n        <strong>Apellis Forward-Looking Statement<\/strong>\u00a0<br \/>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 \u201cforward-looking statements\u201d within the meaning of The Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements regarding timing of anticipated regulatory submissions. The words \u201canticipate,\u201d \u201cbelieve,\u201d \u201ccontinue,\u201d \u201ccould,\u201d \u201cestimate,\u201d \u201cexpect,\u201d \u201cintend,\u201d \u201cmay,\u201d \u201cplan,\u201d \u201cpotential,\u201d \u201cpredict,\u201d \u201cproject,\u201d \u201cshould,\u201d \u201ctarget,\u201d \u201cwill,\u201d \u201cwould\u201d 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 the results of the FILLY, DERBY and OAKS trials are sufficient to support regulatory submissions; whether a submission for approval of intravitreal pegcetacoplan for GA on the basis of the FILLY, DERBY and OAKS trials will be accepted by the FDA or foreign regulatory agencies; whether intravitreal pegcetacoplan will receive approval from the FDA or equivalent foreign regulatory agencies for GA when expected or at all; and other factors discussed in the \u201cRisk Factors\u201d section of Apellis\u2019 Annual Report on Form 10-K with the Securities and Exchange Commission on February 28, 2022 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.<\/p>\n<p>\n        <strong>Media\u00a0Contact:<\/strong>\u00a0<br \/>Lissa Pavluk<br \/><a href=\"https:\/\/www.globenewswire.com\/Tracker?data=SiU85IqBlSagb42iaOtl-WvSfH28pCFzG2sfMLdwuszCVSFTf0YBU03Vj7cl8oSriXn4wPaOHzJ947S_0g7vzg==\" rel=\"nofollow noopener\" target=\"_blank\">media@apellis.com<\/a><br \/>617.977.6764<\/p>\n<p>\n        <strong>Investor Contact:<\/strong>\u00a0<br \/>Meredith Kaya\u00a0<br \/><a href=\"https:\/\/www.globenewswire.com\/Tracker?data=C0DKmjVMeR3YlYo827FbAYuZNeBBcft9litr3dHMPHFGHVciCdnn7u4tFP69JBCM0tmOrYqN0anCMcbMbqTrKZTLHAVX5zN2u20QKWeQWE4=\" rel=\"nofollow noopener\" target=\"_blank\">meredith.kaya@apellis.com<\/a><a href=\"https:\/\/www.globenewswire.com\/Tracker?data=ayHwNO3gJ49o0Ehwe9HyHadJ_u0po5SEKSMxCN_gZCqDg5OEmas1KDvqkpf-7g1rrJRX89kHPXKDFVUnZxsOeQ==\" rel=\"nofollow noopener\" target=\"_blank\"><br \/><\/a>617.599.8178<\/p>\n<table style=\"border-collapse: collapse;width:100%;border-collapse:collapse\">\n<tr>\n<td>\n            <sub>1\u00a0Rudnicka 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.\u00a0Ophthalmology\u00a02012;119:571\u2013580.<\/sub><br \/>\n            <br \/>\n            <sub>2\u00a0Wong 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.\u00a0Lancet Glob Health\u00a02014;2:e106\u2013116.<\/sub><br \/>\n            <br \/>\n            <sub>3\u00a0Lindblad AS, et al, and AREDS Research Group. Arch Ophthalmol. 2009;127(9):1168-1174.<\/sub><br \/>\n            <br \/>\n            <sub>4\u00a0Seddon, JM, Rosner, B. Validated prediction models for macular degeneration progression and predictors of visual acuity loss identify high-risk individuals. Am J Ophthalmol 2019;198:223\u2013261.<\/sub>\n          <\/td>\n<\/tr>\n<\/table>\n<p>      <img decoding=\"async\" class=\"__GNW8366DE3E__IMG\" src=\"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=ODY1NjQwMiM1MTgwMDMzIzIwMjAwMjY=\" \/><br \/>\n      <br \/>\n      <img decoding=\"async\" src=\"https:\/\/ml.globenewswire.com\/media\/NTRiNDFkYmUtNmUxYi00ZDI2LWI1MDMtN2VlODQyN2ZhMzcxLTEwMzE1OTg=\/tiny\/Apellis-Pharmaceuticals-Inc-.png\" \/>\n    <\/div>\n<div class=\"mw_contactinfo\"><\/div>\n","protected":false},"excerpt":{"rendered":"<p>WALTHAM, Mass., Sept. 30, 2022 (GLOBE NEWSWIRE) &#8212; Apellis Pharmaceuticals, Inc. (Nasdaq: APLS), a global biopharmaceutical company and leader in complement, today announced that four oral presentations of data from the Phase 3 DERBY and OAKS studies evaluating pegcetacoplan for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration will be presented at the American Academy of Ophthalmology (AAO) Annual Meeting on September 30 \u2013 October 3 in Chicago, Illinois. Data highlights include detailed 24-month results of safety and efficacy as well as exploratory analyses of lesion growth data and photoreceptor changes utilizing artificial intelligence guided image processing. \u201cOur scientific presence at AAO this year is a testament to our leadership in retina and the potential of pegcetacoplan &hellip; <\/p>\n<p class=\"link-more\"><a href=\"https:\/\/www.marketnewsdesk.com\/index.php\/apellis-announces-four-oral-presentations-of-data-from-the-phase-3-derby-and-oaks-studies-of-pegcetacoplan-in-geographic-atrophy-ga-to-be-presented-at-the-american-academy-of-ophthalmology-annual-me\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;Apellis Announces Four Oral Presentations of Data from the Phase 3 DERBY and OAKS Studies of Pegcetacoplan in Geographic Atrophy (GA) to be Presented at the American Academy of Ophthalmology Annual Meeting&#8221;<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[],"tags":[],"class_list":["post-690634","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.5 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Apellis Announces Four Oral Presentations of Data from the Phase 3 DERBY and OAKS Studies of Pegcetacoplan in Geographic Atrophy (GA) to be Presented at the American Academy of Ophthalmology Annual Meeting - Market Newsdesk<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.marketnewsdesk.com\/index.php\/apellis-announces-four-oral-presentations-of-data-from-the-phase-3-derby-and-oaks-studies-of-pegcetacoplan-in-geographic-atrophy-ga-to-be-presented-at-the-american-academy-of-ophthalmology-annual-me\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Apellis Announces Four Oral Presentations of Data from the Phase 3 DERBY and OAKS Studies of Pegcetacoplan in Geographic Atrophy (GA) to be Presented at the American Academy of Ophthalmology Annual Meeting - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"WALTHAM, Mass., Sept. 30, 2022 (GLOBE NEWSWIRE) &#8212; Apellis Pharmaceuticals, Inc. (Nasdaq: APLS), a global biopharmaceutical company and leader in complement, today announced that four oral presentations of data from the Phase 3 DERBY and OAKS studies evaluating pegcetacoplan for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration will be presented at the American Academy of Ophthalmology (AAO) Annual Meeting on September 30 \u2013 October 3 in Chicago, Illinois. Data highlights include detailed 24-month results of safety and efficacy as well as exploratory analyses of lesion growth data and photoreceptor changes utilizing artificial intelligence guided image processing. \u201cOur scientific presence at AAO this year is a testament to our leadership in retina and the potential of pegcetacoplan &hellip; Continue reading &quot;Apellis Announces Four Oral Presentations of Data from the Phase 3 DERBY and OAKS Studies of Pegcetacoplan in Geographic Atrophy (GA) to be Presented at the American Academy of Ophthalmology Annual Meeting&quot;\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.marketnewsdesk.com\/index.php\/apellis-announces-four-oral-presentations-of-data-from-the-phase-3-derby-and-oaks-studies-of-pegcetacoplan-in-geographic-atrophy-ga-to-be-presented-at-the-american-academy-of-ophthalmology-annual-me\/\" \/>\n<meta property=\"og:site_name\" content=\"Market Newsdesk\" \/>\n<meta property=\"article:published_time\" content=\"2022-09-30T11:03:11+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=ODY1NjQwMiM1MTgwMDMzIzIwMjAwMjY=\" \/>\n<meta name=\"author\" content=\"Newsdesk\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Newsdesk\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"5 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/apellis-announces-four-oral-presentations-of-data-from-the-phase-3-derby-and-oaks-studies-of-pegcetacoplan-in-geographic-atrophy-ga-to-be-presented-at-the-american-academy-of-ophthalmology-annual-me\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/apellis-announces-four-oral-presentations-of-data-from-the-phase-3-derby-and-oaks-studies-of-pegcetacoplan-in-geographic-atrophy-ga-to-be-presented-at-the-american-academy-of-ophthalmology-annual-me\\\/\"},\"author\":{\"name\":\"Newsdesk\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/#\\\/schema\\\/person\\\/482f27a394d4fda80ecb5499e519d979\"},\"headline\":\"Apellis Announces Four Oral Presentations of Data from the Phase 3 DERBY and OAKS Studies of Pegcetacoplan in Geographic Atrophy (GA) to be Presented at the American Academy of Ophthalmology Annual Meeting\",\"datePublished\":\"2022-09-30T11:03:11+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/apellis-announces-four-oral-presentations-of-data-from-the-phase-3-derby-and-oaks-studies-of-pegcetacoplan-in-geographic-atrophy-ga-to-be-presented-at-the-american-academy-of-ophthalmology-annual-me\\\/\"},\"wordCount\":1072,\"image\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/apellis-announces-four-oral-presentations-of-data-from-the-phase-3-derby-and-oaks-studies-of-pegcetacoplan-in-geographic-atrophy-ga-to-be-presented-at-the-american-academy-of-ophthalmology-annual-me\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/www.globenewswire.com\\\/newsroom\\\/ti?nf=ODY1NjQwMiM1MTgwMDMzIzIwMjAwMjY=\",\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/apellis-announces-four-oral-presentations-of-data-from-the-phase-3-derby-and-oaks-studies-of-pegcetacoplan-in-geographic-atrophy-ga-to-be-presented-at-the-american-academy-of-ophthalmology-annual-me\\\/\",\"url\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/apellis-announces-four-oral-presentations-of-data-from-the-phase-3-derby-and-oaks-studies-of-pegcetacoplan-in-geographic-atrophy-ga-to-be-presented-at-the-american-academy-of-ophthalmology-annual-me\\\/\",\"name\":\"Apellis Announces Four Oral Presentations of Data from the Phase 3 DERBY and OAKS Studies of Pegcetacoplan in Geographic Atrophy (GA) to be Presented at the American Academy of Ophthalmology Annual Meeting - 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(Nasdaq: APLS), a global biopharmaceutical company and leader in complement, today announced that four oral presentations of data from the Phase 3 DERBY and OAKS studies evaluating pegcetacoplan for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration will be presented at the American Academy of Ophthalmology (AAO) Annual Meeting on September 30 \u2013 October 3 in Chicago, Illinois. 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