SYFOVRE (Pegcetacoplan Injection) Preserved Visual Function at 36 Months in GALE Extension Study in Geographic Atrophy (GA)
SYFOVRE (Pegcetacoplan Injection) Preserved Visual Function at 36 Months in GALE Extension Study in Geographic Atrophy (GA)
-
SYFOVRE is the only approved GA treatment to demonstrate a visual function benefit in a prespecified endpoint
-
Data presented at the Clinical Trials at the Summit Meeting
-
SYFOVRE是唯一一種獲批的治療GA(視網膜色素變性的一種)的治療方法,已經在規定終點展現出視覺功能的改善。
-
在臨床試驗峯會上介紹的數據。
WALTHAM, Mass., June 10, 2024 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. (Nasdaq: APLS) today announced that SYFOVRE(pegcetacoplan injection) preserved visual function at 36 months in patients with geographic atrophy (GA) secondary to age-related macular degeneration (AMD). These positive data from the GALE long-term extension study were presented at the Clinical Trials at the Summit (CTS) Meeting on June 8 in Park City, Utah.
2024年6月10日,馬薩諸塞州沃爾瑟姆(WALTHAM),全球新聞發佈(GLOBE NEWSWIRE)--Apellis Pharmaceuticals,Inc.(納斯達克代碼:APLS)今天宣佈SYFOVRE。(pegcetacoplan注射)在年齡相關性黃斑變性(GA)次生的地理萎縮(GA)患者身上,在36個月內保持視網膜功能。這些來自GALE長期擴展研究的積極數據,隨後於6月8日在猶他州帕克市的CTS(Study on Clinical Trials)會議上呈現。
"SYFOVRE is the only approved GA treatment to show a benefit on visual function in a prespecified endpoint," said Dilsher Dhoot, M.D., presenting author, vitreoretinal surgeon, California Retina Consultants, Santa Barbara, CA. "The vision loss caused by GA is devastating for patients, taking away their ability to drive and read. These groundbreaking data clearly demonstrate SYFOVRE's potential to make a meaningful difference for patients."
“SYFOVRE是唯一一種獲批的GA治療方法,在指定的終點展現出視覺功能的好處,”加州視網膜顧問醫師、玻璃體視網膜外科醫師、主持作者Dilsher Dhoot醫生表示,“GA帶來的視力損失對患者來說是災難性的,剝奪了他們駕駛和閱讀的能力。這些開創性的數據明確證明SYFOVRE對患者有實際意義。”
In a prespecified microperimetry endpoint, patients developed fewer new scotomatous points with 36 months of both continuous monthly (p=0.0156) and every-other-month (p=0.1233) treatment compared to patients from the sham crossover group (all p-values nominal). Scotomatous points measure areas of the retina that have lost all light sensitivity and therefore are no longer functioning.
在預先規定的微視野端點外,36個月的連續月輸(p=0.0156)和隔月輸(p=0.1233)治療的患者比隨機交叉組的患者發展的新的暗點少。 暗點測量已失去所有光敏感性的視網膜區域,因此它們已經停止工作。
"These results further reinforce the importance of slowing GA lesion growth to preserve visual function, adding to the largest body of evidence for a GA treatment," said Caroline Baumal, M.D., chief medical officer, Apellis. "As leaders in GA, we are committed to advancing our understanding of the benefits of SYFOVRE on this progressive and long-term disease."
“這些結果進一步證明了減緩GA病竈增長對保持視功能的重要性,進一步證明了GA治療的最大體證據。”結構和血管專家、副教授,Apellis公司首席醫學官Caroline Baumal醫生說,“作爲GA領域的領導者,我們致力於推進我們對SYFOVRE在這種逐漸惡化的長期疾病上的好處的理解。”
About the GALE Long-Term Extension Study
GALE (n=792) is a Phase 3, multicenter, open-label, extension study to evaluate the long-term efficacy and safety 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. GALE also includes 10 patients who were previously enrolled in the Phase 1b study of pegcetacoplan for GA.
關於GALE長期擴展研究
GALE(n=792)是一項第3階段、多中心、開放標籤、擴展性研究,旨在評估SYFOVRE(pegcetacoplan注射)在依賴於年齡相關性黃斑變性(AMD)的地理萎縮(GA)患者中的長期療效和安全性。這項研究的目標是評估長期發生並持續存在的眼內和全身治療緊急不良事件的發生率和嚴重程度以及根據眼底自發熒光檢查(FAF)測量的GA病變總面積的改變。超過80%的參與OAKS和DERBY研究完成的患者進入GALE研究。GALE還包括之前在用於GA的pegcetacoplan的第1b期研究中註冊的10名患者。從第3階段OAKS研究開始,虛假轉換組的患者在0-24個月進行虛假治療,並從24-36個月接受SYFOVRE治療。顯微視野測量是僅在OAKS研究中進行的一個關鍵次要指標,因此,從OAKS研究接受交叉治療的患者被納入此分析。
Patients in the sham crossover group completed sham treatment from Months 0-24 in the Phase 3 OAKS study and received SYFOVRE from Months 24-36. Microperimetry was a key secondary endpoint measured only in the OAKS study, and therefore, patients who crossed over from the OAKS study were included in this analysis.
關於第3階段OAKS和DERBY研究
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.
OAKS(n=637)和DERBY(n=621)是第3階段、多中心、隨機、雙盲、虛假對照研究,旨在比較SYFOVRE (pegcetacoplan注射) 和虛假注射對年齡相關性黃斑變性(GA)患者總體面積改變的治療效果和安全性。這些研究通過眼底自發熒光測量評估GA患者的每月治療和隔月 治療的有效性。
在24個月的第3階段研究中,每兩個月和每月輸注的SYFOVRE均能減緩GA病變的增長,並隨着時間的推移呈現出越來越好的療效,並展示出良好的安全性。關於SYFOVRE
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.
SYFOVRE(pegcetacoplan注射)是首個獲批用於治療地理萎縮(GA)的療法。通過針對C3作用,SYFOVRE旨在提供對互補級聯的全面控制,而互補級聯是機體免疫系統的一部分。SYFOVRE已獲批用於美國治療由年齡相關性黃斑變性引起的GA。
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.
(pegcetacoplan注射)關於PEG測紋注射
PEG測紋注射(pegcetacoplan注射)是治療地理萎縮(GA)的首個獲批療法。通過針對C3作用,SYFOVRE旨在提供對互補級聯的全面控制,而互補級聯是機體免疫系統的一部分。SYFOVRE已獲得美國批准,用於治療由年齡相關性黃斑變性引起的GA。
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
關於地理萎縮症(GA)
地理萎縮症(GA)是老年性黃斑部病變的高級形式,全球主要致盲原因之一,影響100萬美國人和500萬全球患者。病變的增長破壞視網膜細胞,導致視力障礙。受GA引起的視力喪失,嚴重影響生活質量和獨立性,使日常活動變得困難。平均來說,只需要2.5年,GA病變就會開始影響負責中央視覺的黃斑區。1,2這是一種逐漸發展且不可逆轉的疾病,由病變的增長引起,破壞負責視覺的視網膜細胞。由GA引起的視力障礙嚴重影響獨立性和生活質量,使日常活動變得困難。平均只需要2.5年,GA病變就會開始影響負責中央視覺的黃斑區。3
U.S. Important Safety Information for SYFOVRE (pegcetacoplan injection)
CONTRAINDICATIONS
SYFOVRE的美國重要安全信息(pegcetacoplan注射)
禁忌症
- SYFOVRE is contraindicated in patients with ocular or periocular infections, and in patients with active intraocular inflammation
- SYFOVRE對患有眼部或眼周感染以及有活動性眼內炎症的患者具有禁忌症。
WARNINGS AND PRECAUTIONS
警告及注意事項
- 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.
- 眼內炎症和視網膜脫離
- 包括SYFOVRE的眼內注射可能與眼內炎症和視網膜脫離相關聯。在注射SYFOVRE時必須始終使用適當的無菌注射技術,以最小化眼內炎症的風險。應告知患者如有任何提示眼內炎症或視網膜脫離的症狀,應立即報告,並應適當處理。
- 視網膜血管炎和/或視網膜血管阻塞
- 使用SYFOVRE可能會出現視網膜血管炎和/或視網膜血管阻塞,通常伴隨眼內炎症發生,可能導致嚴重的視力損失。對於出現此類事件的患者,請停止使用SYFOVRE。患者應告知如有任何視力變化應立即報告。
- 新生血管性AMD
- 在臨床試驗中,使用SYFOVRE與新生血管性(wet)AMD或脈絡膜新生血管形成相關聯(每月一次給藥組爲12%,每兩個月一次給藥組爲7%,對照組爲3%)在24個月內。接受SYFOVRE治療的患者應監測新生血管性AMD的跡象。如果需要抗血管內皮生長因子(anti-VEGF)治療,應與SYFOVRE分開使用。
- 眼內炎症
- 在臨床試驗中,使用SYFOVRE與眼內炎症的發作相關聯,包括玻璃體混濁、玻璃體細胞、虹膜睫狀體炎、眼內炎症、前房混濁、虹膜炎和前房懸浮液混濁。眼內炎症消退後,患者可以繼續使用SYFOVRE進行治療。
- 眼內壓力升高
- 任何眼內注射,包括SYFOVRE,都可能在幾分鐘內導致急性眼內壓升高。注射後應監測視神經頭的灌注並進行必要的處理。
ADVERSE REACTIONS
不良反應
- Most common adverse reactions (incidence ≥5%) are ocular discomfort, neovascular age-related macular degeneration, vitreous floaters, conjunctival hemorrhage.
- 最常見的不良反應(發生率≥5%)包括眼不適、新生血管性年齡相關性黃斑部病變、玻璃體浮游物和結膜出血。
Please see accompanying full Prescribing Information for more information.
有關Teva:泰瓦製藥有限公司(紐約證券交易所和特拉維夫證券交易所:TEVA)是全球製藥領導者,擁有一系列類別界定性的產品組合,利用我們的常規產品專業知識並積極推動創新,不斷爲現代醫藥的發現、推廣和擴展發展勢頭增勢。一百二十多年來,Teva致力於改善健康。今天,該公司在58個市場擁有約37,000名員工構成的全球網絡,推動科學創新的發展邊界,併爲每天幫助改善數百萬患者的健康狀況提供優質藥品。獲取更多有關Teva如何致力於更好的健康的信息,請訪問。處方說明了解更多信息。
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.
關於Apellis
Apellis Pharmaceuticals, Inc.是一家全球性生物製藥公司,融合了勇氣科學和同情心,爲一些患者面臨的最具挑戰性的疾病開發改變生命的療法。我們引進了15年來的第一類新的互補醫學,並已經獲得兩個批准的藥物,針對C3。這些包括全球最主要致盲病因之一的地理性萎縮的第一個療法。我們認爲,我們只是開始解鎖針對C3治療嚴重的視網膜,罕見疾病和神經系統疾病的潛力。http://apellis.com或關注我們的推特和頁面。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
Apellis前瞻性聲明
本新聞稿中關於未來預期、計劃和前景的陳述以及有關非歷史事實的其他陳述,可能構成《1995年私人證券訴訟改革法案》規定下的"前瞻性陳述"。儘管並非所有前瞻性陳述都包含這些識別性詞語,但"預期"、"相信"、"持續"、"可能"、"估計"、"期望"、"打算"、"可能"、"計劃"、"潛在"、"預測"、"項目"、"應該"、"目標"、"將"、"將會"等類似表述的詞語,都是用於識別前瞻性陳述的。由於各種重要因素和其他因素的影響,《Apellis公司在2024年2月27日向證券交易委員會提交的10-K表格中的"風險因素"部分以及Apellis可能向證券交易委員會提交的其他文件中討論的風險,實際結果可能與此類前瞻性聲明所示結果有所不同。本新聞稿中包含的任何前瞻性陳述僅於發表日期作出,Apellis明確聲明不承擔更新任何前瞻性聲明的任何義務,無論是因爲新信息、未來事件還是其他原因。
媒體聯繫人:
Lissa Pavluk
media@apellis.com
617.977.6764
Investor Contact:
Meredith Kaya
meredith.kaya@apellis.com
617.599.8178
投資者聯繫:
Meredith Kaya
meredith.kaya@apellis.com617.599.8178
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.
1Rudnicka AR,Jarrar Z,Wormald R等。白種歐洲人口中年齡相關黃斑變性的患病率的年齡和性別變異:一項Meta分析。Ophthalmology 2012;119:571-580。
2Wong WL,Su X,Li X等。全球年齡相關黃斑變性的患病率及2020年和2040年的疾病負擔預測:一項系統評價和Meta分析。Lancet Glob Health 2014;2:e106-116。
3Lindblad AS等,以及AREDS研究小組。Arch Ophthalmol。2009年;127(9):1168-1174。
譯文內容由第三人軟體翻譯。