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Alcon Announces European Launch of Vivity, the Only Presbyopia-correcting Intraocular Lens With X-WAVETechnology

Alcon Announces European Launch of Vivity, the Only Presbyopia-correcting Intraocular Lens With X-WAVETechnology

愛爾康宣佈在歐洲推出 Vivity,這是唯一採用 X 波技術的老花矯正眼鏡
Business Wire ·  2020/03/12 06:00

Vivity complements Alcon’s existing IOL portfolio by providing an additional option for cataract patients to treat presbyopiaA first-of-its-kind, non-diffractive lens that offers a continuous extended range of vision while maintaining a low incidence of visual disturbances, like a monofocal IOLVivity launches in select European countries with additional markets coming throughout 2020

活力相輔相成阿爾康通過為白內障患者提供治療老花眼的另一種選擇,該公司現有的IOL產品組合是一款首創的無衍射鏡片,可提供連續的延長視力範圍,同時保持較低的視覺障礙發生率,如在選定的歐洲國家推出單焦點IOL Vitivity,並將於2020年推出更多市場

Alcon (SIX/NYSE:ALC), the global leader in eye care announced AcrySof® IQ Vivity®, a first-of-its-kind intraocular lens (IOL) is now commercially available in select European markets, with additional countries to follow throughout 2020.

全球眼科護理領先者愛爾康(SIX/紐約證券交易所股票代碼:ALC)宣佈,AcrySof®IQ Vivitity®是同類產品中第一款人工晶狀體現在在選定的歐洲市場上可以商業使用,在整個2020年還將有更多的國家效仿。

The latest innovation in Alcon’s portfolio of presbyopia-correcting IOLs (PC-IOLs), Vivity is the first-of-its-kind, extended range of vision IOL that uses non-diffractive design called X-WAVE™technology to reduce a cataract patient’s dependency on glasses. According to patient-reported outcomes, Vivity enables high-quality vision at far and intermediate ranges as well as functional up-close vision. Available in spherical and toric designs, Vivity is built on Alcon’s proven AcrySof IQ IOL platform that has been implanted in more than 120 million eyes globally.

作為愛爾康矯正老花眼人工晶狀體(PC-IOL)產品組合中的最新創新,VIERITY是同類產品中第一款使用稱為X-WAVE™技術的無衍射設計的擴大視力的人工晶狀體,以減少白內障患者對眼鏡的依賴。根據患者報告的結果,Vivity能夠實現遠、中距離的高質量視力以及功能性近距離視力。Vitivity有球形和環形兩種設計,它是建立在愛爾康久經考驗的AcrySof IQ IOL平臺上的,該平臺已經在全球超過1.2億隻眼睛植入。

“We are excited to introduce Vivity because it addresses some common concerns of surgeons and cataract patients alike when considering presbyopia-correcting IOLs (PC-IOLs),” said Michael Onuscheck, President, Global Business and Innovation at Alcon. “This novel non-diffractive lens option provides PC-IOL performance with the ease of monofocal patient management.”

愛爾康公司全球業務與創新部主任邁克爾·奧努斯切克表示:“我們很高興能推出Vivity,因為它解決了外科醫生和白內障患者在考慮植入矯正老花眼的人工晶狀體(PC-IOL)時共同關心的一些問題。”這種新的無衍射透鏡選項提供了PC-IOL性能,使單焦點患者的管理變得容易。“

Alcon’s proprietary non-diffractive technology uses two smooth surface transition elements on the anterior surface of the IOL that work simultaneously to create continuous, extended range of vision rather than separate focal points. Recent clinical trials found Vivity provides very good quality of vision at distance and intermediate ranges in bright and dim light. Without glasses, 94 percent of patients reported good or very good vision at distance, and 92 percent reported good or very good vision at arm’s length.1Additionally, patients using Vivity reported such low levels of starbursts, halos and glares that Vivity’s visual disturbance profile is comparable to a monofocal lens.2

愛爾康專有的無衍射技術在人工晶狀體前表面使用兩個光滑的表面過渡元素,它們同時工作,以創造連續的、擴大的視野範圍,而不是單獨的焦點。最近的臨牀試驗發現,在明亮和昏暗的光線下,Vivity在遠距離和中等距離都能提供非常好的視覺質量。在不戴眼鏡的情況下,94%的患者報告遠距離視力良好或非常好,92%的患者報告在手臂距離處視力良好或非常好。1此外,使用Viille的患者報告的星光爆發、光暈和眩光水平如此之低,以至於Vivity的視覺障礙輪廓與單焦點透鏡相當。2

Following FDA approval in February, Alcon will begin launching Vivity with select U.S. ophthalmologists over the coming months, with broader U.S. availability to be announced later this year.

在FDA於2月份批准後,愛爾康將在未來幾個月開始與精選的美國眼科醫生一起推出Vivite,並將於今年晚些時候宣佈在美國更廣泛的應用。

“As we continue to focus on the ongoing launch of PanOptix® in the U.S., we look forward to launching Vivity as a complementary lens in more markets throughout the year,” added Onuscheck.

奧努斯切克補充説:“隨着我們繼續專注於在美國推出Panoptix®,我們期待着全年在更多市場推出作為補充鏡頭的VERVITY。”

Alcon is the leading manufacturer of intraocular lenses. Of the 20 million cataract procedures conducted globally each year, only 4% of patients receive PC-IOLs. Now, with a lens that offers a visual disturbance profile comparable to the industry-leading AcrySof IQ monofocal lens, Vivity offers cataract surgeons another option to deliver better outcomes for their patients.

愛爾康是人工晶狀體的領先製造商。在全球每年進行的2000萬例白內障手術中,只有4%的患者接受了PC-IOL。現在,憑藉一款可提供與行業領先的AcrySof IQ單焦點鏡片相媲美的視力障礙輪廓的鏡片,Vivity為白內障外科醫生提供了另一種選擇,為他們的患者提供更好的結果。

About Cataracts

關於白內障

A cataract is a cloudy area in the natural lens of the eye that affects vision. As a cataract develops, the eye’s lens gradually becomes hard and cloudy allowing less light to pass through, which makes it more difficult to see. The vast majority of cataracts result from normal aging, but radiation exposure, taking steroids, diabetes and eye trauma can accelerate their development.3Cataracts are the most common age-related eye condition and the leading cause of preventable blindness.4Cataracts are treated by removing the eye’s cloudy natural lens and surgically replacing it with an intraocular lens or IOL. More than 98% of cataract surgeries are considered successful, and patients typically can return to their normal routines within 24 hours.5

白內障是眼睛自然晶狀體中的一個混濁區域,會影響視力。隨着白內障的發展,眼睛的晶狀體逐漸變得堅硬和混濁,允許較少的光線通過,這使得看東西變得更加困難。絕大多數白內障是由正常衰老引起的,但輻射暴露、服用類固醇、糖尿病和眼睛創傷會加速其發展。3白內障是最常見的與年齡相關的眼病,也是可預防失明的主要原因。4白內障的治療方法是摘除眼睛渾濁的自然晶狀體,然後用人工晶狀體或人工晶狀體取代它。超過98%的白內障手術被認為是成功的,患者通常可以在24小時內恢復正常

About Presbyopia

關於老花眼

Presbyopia is a common, age-related vision condition in which people have difficulty focusing on things up close. It involves the gradual loss of the eye’s ability to focus on close objects, such as smart phones, computers, books and menus.6Almost everyone will experience presbyopia to some degree as they age, with symptoms often first appearing as an individual enters their 40s and continues to worsen into their 60s.6The condition is not a disease, so it cannot be cured; however, there are safe and effective ways to correct presbyopia, including eye glasses, contact lenses or refractive surgery.

老花眼是一種常見的與年齡相關的視力狀況,人們很難近距離地關注事物。它涉及到眼睛的逐漸喪失能力專注於接近的物體,如智能手機、電腦、書籍和菜單。6幾乎每個人都會隨着年齡的增長而經歷不同程度的老花眼,症狀通常是在一個人進入40多歲並持續惡化到60多歲時出現的。6這種情況不是一種疾病,所以它無法治癒;然而,有一些安全矯正老花眼的有效方法,包括眼鏡、隱形眼鏡或屈光手術。

About Vivity

關於Vivity

The non-diffractive AcrySof™ IQ Vivity™ Extended Vision Posterior Chamber Intraocular Lens Model DFT015 (referred to as AcrySof™ IQ Vivity™ IOL) is an UV-absorbing and blue light filtering foldable intraocular lens (IOL). This IOL, compared to a monofocal IOL, provides an extended range of vision from distance to near without increasing the incidence of visual disturbances.

DFT015型無衍射型AcrySof™IQ Vivity™擴展視力後房型人工晶狀體(簡稱AcrySof™IQ Vivity™IOL)是一種可吸收紫外線和藍光過濾的摺疊式人工晶狀體。與單焦點人工晶狀體相比,這種人工晶狀體提供了從遠到近的更大的視野範圍,而不會增加視力障礙的發生率。

Potential side effects: As with any surgery, there is an implicit risk, whether or not the IOL is implanted. The complications of the IOL implantation surgery ranges from minor side effects (usually temporary) to serious complications. Patients with previous illnesses or disorders (such as chronic infections of the eye or eyelids, or diabetes) may present a higher risk of complications. Temporary surgical complications include, but are not limited to, reactions to medications such as irritation or mild allergic response, bleeding, redness, itching of the eye, sensitivity to light, swelling, Corneal edema (swelling of the cornea), problems with the iris, cell growth in the IOL, and an increase temporary eye pressure. There is a small risk of needing further surgical treatment (such as IOL replacement implanted by a different one or surgery to improve vision) after the implantation of the initial IOL.

潛在的副作用:與任何手術一樣,無論人工晶狀體是否植入,都存在隱性風險。人工晶狀體植入手術的併發症從輕微的副作用(通常是暫時的)到嚴重的併發症。既往有疾病或障礙(如眼部或眼皮的慢性感染,或糖尿病)的患者可能會出現更高的併發症風險。暫時性手術併發症包括但不限於對藥物的反應,如刺激或輕微過敏反應、出血、發紅、眼睛瘙癢、對光線敏感、腫脹、角膜浮腫(角膜腫脹)、虹膜問題、人工晶狀體內細胞生長以及暫時性眼壓升高。在植入初始人工晶狀體後,需要進一步手術治療的風險很小(例如,用不同的人工晶狀體植入人工晶狀體或手術改善視力)。

A toric IOL corrects astigmatism when it is placed in the correct position within the eye and remains in the intended position. If the IOL is not correctly positioned and does not remain in its intended position to correct astigmatism, you may experience visual distortions, where curved lines appear inclined or flat surfaces will appear curved. These visual distortions can make you dizzy.

環形人工晶狀體可以矯正散光,當它被放置在眼睛內的正確位置並保持在預期位置時。如果人工晶狀體的位置不正確,並且沒有保持在矯正散光的預期位置,您可能會遇到視覺扭曲,曲線看起來傾斜,或者平面看起來是彎曲的。這些視覺扭曲會讓你頭暈目眩。

Disclaimer

免責

This press release contains “forward-looking statements” within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as: “anticipate,” “intend,” “commitment,” “look forward,” “maintain,” “plan,” “goal,” “seek,” “believe,” “project,” “estimate,” “expect,” “strategy,” “future,” “likely,” “may,” “should,” “will” and similar references to future periods.

本新聞稿包含符合1995年美國私人證券訴訟改革法安全港條款的“前瞻性陳述”。前瞻性陳述可以通過以下詞語來識別:“預期”、“打算”、“承諾”、“展望”、“維持”、“計劃”、“目標”、“尋求”、“相信”、“項目”、“估計”、“預期”、“戰略”、“未來”、“可能”、“可能”、“應該”、“將”以及對未來時期的類似提法。

Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties and risks that are difficult to predict. Some of these factors are discussed in our filings with the United States Securities and Exchange Commission, including our Form 20-F. Should one or more of these uncertainties or risks materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those anticipated. Therefore, you should not rely on any of these forward-looking statements.

前瞻性陳述既不是歷史事實,也不是對未來業績的保證。相反,它們只基於我們目前對業務未來、未來計劃和戰略以及其他未來條件的信念、預期和假設。由於前瞻性陳述涉及未來,它們受到難以預測的內在不確定性和風險的影響。其中一些因素在我們提交給美國證券交易委員會的文件中進行了討論,包括我們的Form 20-F。如果這些不確定性或風險中的一個或多個成為現實,或者潛在的假設被證明是不正確的,實際結果可能與預期的結果大不相同。因此,您不應依賴這些前瞻性陳述中的任何一種。

Forward-looking statements in this press release speak only as of the date of its filing, and we assume no obligation to update forward-looking statements as a result of new information, future events or otherwise.

本新聞稿中的前瞻性陳述僅代表截止提交之日的情況,我們不承擔因新信息、未來事件或其他情況而更新前瞻性陳述的義務。

ReferencesAlcon Data on file, 2019.Alcon Data on file, 2019.National Institutes of Health (NIH), National Eye Institute (NEI), Causes of Cataract. Accessed March 5, 2020. Available at: https://www.nei.nih.gov/learn-about-eye-health/eye-conditions-and-diseases/cataracts/causes-cataract.Centers for Disease Control and Prevention, Vision Health Initiative. Accessed March 5, 2020. Available at: https://www.cdc.gov/visionhealth/basics/ced/index.htm .Cleveland Clinic, Cataracts. Accessed March 5, 2020. Available at: https://my.clevelandclinic.org/health/diseases/8589-cataracts .Mayo Clinic, Presbyopia. Accessed August 12, 2019. Available at: https://www.mayoclinic.org/diseases-conditions/presbyopia/symptoms-causes/syc-20363328 .

參考文獻Alcon數據備案,2019年Alcon數據備案,美國國立衞生研究院(NIH),全國眼科研究所(NEI),白內障的原因。訪問時間為2020年3月5日。可在:https://www.nei.nih.gov/learn-about-eye-health/eye-conditions-and-diseases/cataracts/causes-cataract.Centers疾病控制和預防,視覺健康倡議。訪問時間為2020年3月5日。可在:https://www.cdc.gov/visionhealth/basics/ced/index.htm。克利夫蘭診所購買,白內障。訪問時間為2020年3月5日。可在:https://my.clevelandclinic.org/health/diseases/8589-cataracts。梅奧診所,老花眼購買。訪問時間為2019年8月12日。詳情請登錄:https://www.mayoclinic.org/diseases-conditions/presbyopia/symptoms-causes/syc-20363328。

About Alcon

關於愛爾康

Alcon helps people see brilliantly. As the global leader in eye care with a heritage spanning more than seven decades, we offer the broadest portfolio of products to enhance sight and improve people’s lives. Our Surgical and Vision Care products touch the lives of more than 260 million people in over 140 countries each year living with conditions like cataracts, glaucoma, retinal diseases and refractive errors. Our more than 20,000 associates are enhancing the quality of life through innovative products, partnerships with eye care professionals and programs that advance access to quality eye care. Learn more at www.alcon.com .

愛爾康幫助人們看得很清楚。作為眼部護理領域的全球領導者,遺產跨越70多年,我們提供最廣泛的產品組合,以增強視力和改善人們的生活。我們的手術和視力護理產品每年接觸140多個國家和地區2.6億多患有白內障、青光眼、視網膜疾病和屈光不正等疾病的人的生活。我們的20,000多名員工正在通過創新的產品、與眼部護理專業人員的合作伙伴關係以及促進獲得高質量眼部護理的計劃來提高生活質量。欲瞭解更多信息,請訪問www.alcon.com。

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