NASHVILLE, Tenn.--(BUSINESS WIRE)--Harrow (Nasdaq: HROW), a leading U.S. eyecare pharmaceutical company, today announced that VEVYE® (cyclosporine ophthalmic solution) 0.1%, a patented, non‑preserved, twice-daily (BID) dosed prescription drug based on a “water‑free” semifluorinated alkane eyedrop technology, is now available in the U.S.

田纳西州纳什维尔（商业新闻短讯）--美国领先的眼保健制药公司哈罗（Nasdaq:HROW）今天宣布，VEVYE®（环孢素眼用溶液）0.1%，一种基于“无水”半氟化烷烃滴眼液技术的专利非保藏每日两次（BID）剂量处方药，现已在美国上市。

– and includes a 100% Money‑Back Guarantee program. VEVYE, uniquely dispensed in a 10 microliter drop, is the first and only cyclosporine‑based product indicated for treating both the signs and symptoms of dry eye disease (DED)..

–并包括100%退款担保计划。VEVYE以10微升的滴度独特配药，是第一款也是唯一一款基于环孢菌素的产品，用于治疗干眼症（DED）的体征和症状。。

In commenting on the announcement, Mark L. Baum, Chairman and Chief Executive Officer of Harrow, said, “We are thrilled to announce the availability of VEVYE for our customers and their patients. VEVYE is powered by the unique combination of the reliable and trusted active ingredient, cyclosporine, and a water-free semifluorinated alkane delivery vehicle, perfluorobutylpentane.

哈罗董事长兼首席执行官马克·鲍姆（Mark L.Baum）在评论这一宣布时表示：“我们很高兴宣布为我们的客户及其患者提供VEVYE。VEVYE的动力来自可靠可靠的活性成分环孢菌素和无水半氟化烷烃运载工具全氟丁基戊烷的独特组合。

We are excited to see VEVYE’s exceptional clinical trial data come to life as U.S. dry eye disease patients are now able to access and experience a highly tolerable product that provides rapid onset of relief and sustained improvement of both signs and symptoms of dry eye disease. Because of VEVYE’s unique combination of both a potent 0.1% cyclosporine solute and a pH- and osmolarity-free semifluorinated alkane, VEVYE is both evolutionary and revolutionary, solving an unmet need for eyecare professionals treating the tens of millions of American chronic dry eye disease sufferers.”.

随着美国干眼病患者现在能够获得并体验到一种高度耐受的产品，该产品可以快速缓解干眼病的症状，并持续改善其体征，我们很高兴看到VEVYE的出色临床试验数据得以实现。由于VEVYE独特地结合了有效的0.1%环孢菌素溶质和不含pH和渗透压的半氟化烷烃，VEVYE既具有进化性又具有革命性，解决了对治疗数千万美国慢性干眼症患者的眼科专业人员的未满足需求。”。

Dry eye disease (DED) is a common condition that occurs when the eyes do not produce enough tears or when the tears evaporate too quickly, and it is often associated with chronic inflammation. Untreated DED can lead to discomfort such as stinging, burning or blurry vision, and chronic DED can interfere with daily activities like reading and using a computer.

干眼症（DED）是一种常见病，当眼睛产生的眼泪不足或眼泪蒸发过快时就会发生，并且通常与慢性炎症有关。未经治疗的DED会导致不适，如刺痛，灼热或视力模糊，慢性DED会干扰阅读和使用电脑等日常活动。

More serious consequences include increased risk of eye infections and damage to the surface of the eye, which can potentially result in serious vision problems and even loss of sight. Causes of dry eye are varied and can include aging, certain medications, medical conditions, or environmental factors such as increased screen time and exposure to pollutants, all of which are contributing to a forecast of continued significant increase in DED.

更严重的后果包括眼部感染风险增加和眼表受损，这可能导致严重的视力问题甚至失明。干眼症的原因多种多样，可能包括衰老，某些药物，医疗条件或环境因素，如筛查时间增加和暴露于污染物，所有这些都有助于预测DED持续显着增加。

According to a 2020 report from Market Scope, DED affects more than 38 million Americans. In addition, 92% of this patient population remains un- or under-treated due to limited efficacy and poor tolerability of existing prescription and non-prescription choices.4.

根据Market Scope 2020年的一份报告，DED影响了3800多万美国人。此外，由于现有处方和非处方选择的疗效有限和耐受性差，92%的患者仍未接受治疗或治疗不足。

Comments from Ophthalmic KOLs (Key Opinion Leaders) on VEVYE

眼科KOL（关键意见领袖）对VEVYE的评论

“As an ophthalmologist and ocular surface specialist, I have served as principal investigator in over 120 clinical trials, half of which targeted dry eye disease. As participants in VEVYE’s clinical trials, our team found the results to be compelling. The data in both consecutive registration trials demonstrated impressive efficacy, safety and tolerability, with rapid clinical onset beginning as early as 15 days and continuous improvement for more than one year.

“作为一名眼科医生和眼表专家，我曾在120多项临床试验中担任首席研究员，其中一半针对干眼症。作为VEVYE临床试验的参与者，我们的团队发现结果令人信服。两项连续注册试验的数据均显示出令人印象深刻的疗效，安全性和耐受性，临床发病迅速最早15天，持续改进一年以上。

VEVYE represents not just an innovative treatment; it exemplifies the penultimate synthesis of outstanding vehicle with cyclosporine, the active pharmaceutical ingredient, boasting a superlative decades long track record. Tolerability and risk profile are impressive compared with most existing dry eye products, portending improved patient compliance.

VEVYE不仅代表了一种创新的治疗方法；它是活性药物成分环孢菌素（cyclosporine）倒数第二次合成杰出载体的例子，拥有长达数十年的最高记录。与大多数现有的干眼症产品相比，耐受性和风险状况令人印象深刻，预示着患者依从性的提高。

Indicated for both signs and symptoms, VEVYE should expand the market and fundamentally enhance dry eye disease treatment algorithms.”.

针对体征和症状，VEVYE应该扩大市场，并从根本上增强干眼症治疗算法。”。

— John D. Sheppard, M.D., M.M.Sc., F.A.C.S., corneal external disease fellowship trained ophthalmologist and founding senior partner of Virginia Eye Consultants, Norfolk, VA

-约翰·谢泼德（JohnD.Sheppard），医学博士，医学硕士，F.A.C.S.，角膜外部疾病研究金（corneal external disease fellowship）训练有素的眼科医生，弗吉尼亚州诺福克市弗吉尼亚眼科顾问公司（Virginia Eye Consultants）的创始高级合伙人

“When a patient presents with dry eye disease, it is often difficult to initially classify them into a specific category, such as aqueous deficient, evaporative, or a combination of the two. In addition, they often present with inflammation leading to many of their dry eye symptoms. That is why VEVYE, with cyclosporine in a semifluorinated alkane solution, provides us with a valuable tool to address the signs and symptoms of dry eye holistically, regardless of etiology.”.

“当患者出现干眼症时，通常很难最初将其分为特定类别，例如缺水，蒸发或两者的结合。此外，他们经常出现炎症，导致许多干眼症。这就是为什么VEVYE在半氟化烷烃溶液中使用环孢菌素为我们提供了一种有价值的工具来治疗无论病因如何，都要对干眼症的体征和症状进行全面的治疗。”。

— Paul Karpecki, OD, FAAO, Director, cornea and external disease, Kentucky Eye Institute, and associate professor, Kentucky College of Optometry UPIKE, Lexington, KY

-保罗·卡佩基（PaulKarpecki），OD，FAAO，肯塔基州眼科研究所角膜和外部疾病主任，肯塔基州列克星敦市肯塔基大学眼科学院副教授

“VEVYE continues the trend of advanced cyclosporine formulations coming to market that are designed to address key issues of onset of action and tolerability. As the first cyclosporine with an FDA indication for signs and symptoms and the first anti‑inflammatory drop in the new category of anhydrous or water-free formulations, VEVYE is well-positioned to add unique clinical value to the expanding market of excellent anti-inflammatory dry eye disease therapeutics.”.

“VEVYE延续了先进的环孢菌素制剂上市的趋势，旨在解决起效和耐受性的关键问题。作为第一种具有FDA指示体征和症状的环孢菌素，以及新型无水或无水制剂中第一种抗炎药，VEVYE处于有利地位，可以为expan增加独特的临床价值丁市场上优秀的抗炎干眼症治疗药物。”。

— Richard Adler, M.D., corneal, refractive, and external disease fellowship trained ophthalmologist at Belcara Health, Baltimore, MD

-医学博士理查德·阿德勒（Richard Adler），在马里兰州巴尔的摩的Belcara Health接受角膜，屈光和外部疾病研究金培训的眼科医生

“As a glaucoma specialist who treats advanced glaucoma, I’ve been looking forward to the availability of VEVYE, a two-hit treatment for ocular surface disease targeting longstanding inflammation and corneal damage in as quickly as 15 days. A large portion of patients with glaucoma also have dry eye disease with extensive cornea damage due to the use of topical glaucoma medications.

“作为一名治疗晚期青光眼的青光眼专家，我一直期待着VEVYE的上市，VEVYE是一种针对眼表疾病的两次治疗方法，可以在15天内针对长期炎症和角膜损伤。由于使用局部青光眼药物，大部分青光眼患者还患有干眼症，并伴有广泛的角膜损伤。

I look forward to the rapid relief my patients will receive from the addition of preservative-free VEVYE.”.

我期待着我的病人能从添加不含防腐剂的VEVYE中得到快速缓解。”。

— Courtney Bovee, M.D., cataract and glaucoma surgeon at The Macula Center and Blue Ocean Clinical Research Center, Tampa Bay, FL.

-佛罗里达州坦帕湾黄斑中心和蓝海临床研究中心白内障和青光眼外科医生CourtneyBovee医学博士。

“Clinicians have been waiting a long time for a dry eye treatment that combines the effectiveness of cyclosporine with the tolerability of this unique semifluorinated alkane vehicle. In VEVYE, the vehicle makes all the difference, allowing the product to spread evenly over the ocular surface with longer residual time and increased penetration of cyclosporine.”.

“临床医生一直在等待一种干眼症治疗，这种治疗将环孢菌素的有效性与这种独特的半氟化烷烃载体的耐受性结合起来。在VEVYE中，载体发挥了所有作用，使产品均匀分布在眼表，残留时间更长，环孢菌素的渗透性增加。”。

— John A. Hovanesian, M.D., cataract, corneal and laser eye surgeon and a principal at Harvard Eye Associates, Laguna Hills, CA

-约翰·霍瓦尼森（JohnA.Hovanesian），医学博士，白内障，角膜和激光眼科医生，加州拉古纳山哈佛眼科协会（HarvardEyeAssociates）校长

“As an eyecare professional, I recognize the critical need for a dry eye product that not only acts swiftly and effectively, but also is comfortable enough to encourage continued patient use. A dry eye product that is well tolerated, has no or mild discomfort or adverse effects, and can easily be incorporated into a patient’s daily routine is key to successful long-term management of dry eye syndrome.

“作为一名眼科护理专业人士，我认识到迫切需要一种干眼症产品，这种产品不仅作用迅速有效，而且足够舒适，可以鼓励患者继续使用。耐受性良好，没有或轻微不适或不良反应，并且可以很容易地纳入患者的日常生活中，是干眼症长期成功管理的关键综合征。

VEVYE’s twice‑daily dosing should also contribute to patient compliance, thus promoting overall effectiveness of the treatment. I am excited to see the positive changes that VEVYE can bring to patients suffering from dry eye disease.”.

VEVYE每天两次的剂量也应该有助于患者的依从性，从而提高治疗的整体有效性。我很高兴看到VEVYE可以为患有干眼症的患者带来积极的变化。”。

— William B. Trattler, M.D., cataract, refractive, and corneal surgeon and Director of Cornea at the Center for Excellence in Eye Care, Miami, FL

-William B.Trattler，医学博士，白内障，屈光和角膜外科医生，佛罗里达州迈阿密卓越眼科护理中心角膜主任

How to Order VEVYE

如何订购VEVYE

Eyecare professionals can send prescriptions for VEVYE, using their electronic medical record (EMR), directly to Harrow’s dedicated pharmacy partner, PhilRx. Prescriptions can also be sent to any retail pharmacy. VEVYE is fully stocked in the wholesale distribution channel and can be shipped to any retail pharmacy, generally within 24 hours of order placement..

眼科专业人员可以使用他们的电子病历（EMR）直接向哈罗专门的药房合作伙伴PhilRx发送VEVYE的处方。处方也可以发送到任何零售药店。VEVYE在批发分销渠道中库存充足，通常可以在下单后24小时内运送到任何零售药店。。

In addition, VEVYE is available directly through the wholesale distributors, including McKesson, Cardinal and Cencora (f/k/a AmerisourceBergen).

此外，VEVYE可直接通过批发分销商获得，包括McKesson、Cardinal和Cencora（f/k/a AmerisourceBergen）。

Interested patients should ask their trusted eyecare professional whether VEVYE is right for them.

感兴趣的患者应该询问他们信任的眼科专业人员VEVYE是否适合他们。

VEVYE Patient Access Program

VEVYE患者访问计划

Harrow has established a VEVYE Patient Access program, under which eligible patients may receive their first VEVYE prescription for as low as $0.5

哈罗已经建立了一个VEVYE患者访问计划，根据该计划，符合条件的患者可以以低至0.5美元的价格获得他们的第一个VEVYE处方

Harrow also offers a 100% money-back guarantee for eligible patients.3

哈罗还为符合条件的患者提供100%退款保证。3

More information on Harrow’s Patient Access program is available at getvevye.com.

有关哈罗病人访问计划的更多信息，请访问getvevye.com。

For more information about VEVYE, please visit vevye.com.

有关VEVYE的更多信息，请访问VEVYE.com。

About Harrow

关于哈罗

Harrow, Inc. (Nasdaq: HROW) is a leading eyecare pharmaceutical company engaged in the discovery, development, and commercialization of innovative ophthalmic pharmaceutical products for the U.S. market. Harrow helps U.S. eyecare professionals preserve the gift of sight by making its comprehensive portfolio of prescription and non-prescription pharmaceutical products accessible and affordable to millions of Americans each year.

哈罗公司（Nasdaq:HROW）是一家领先的眼科制药公司，致力于为美国市场发现、开发和商业化创新眼科药品。哈罗帮助美国眼科护理专业人员保护视力，每年让数百万美国人能够获得并负担得起其处方药和非处方药的综合产品组合。

For more information about Harrow, please visit harrow.com..

有关哈罗的更多信息，请访问哈罗网。。

Forward-Looking Statements

前瞻性声明

This press release contains “forward-looking statements” within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Any statements in this release that are not historical facts may be considered such “forward-looking statements.” Forward-looking statements are based on management's current expectations and are subject to risks and uncertainties which may cause results to differ materially and adversely from the statements contained herein.

本新闻稿包含1995年《美国私人证券诉讼改革法案》所指的“前瞻性声明”。本新闻稿中任何非历史事实的陈述均可被视为“前瞻性陈述”。前瞻性陈述基于管理层当前的预期，并存在风险和不确定性，可能导致结果与本文所载陈述产生重大不利影响。

Some of the potential risks and uncertainties that could cause actual results to differ from those predicted include, among others, risks related to: liquidity or results of operations; our ability to successfully implement our business plan, develop and commercialize our products, product candidates and proprietary formulations in a timely manner or at all, identify and acquire additional products, manage our pharmacy operations, service our debt, obtain financing necessary to operate our business, recruit and retain qualified personnel, manage any growth we may experience and successfully realize the benefits of our previous acquisitions and any other acquisitions and collaborative arrangements we may pursue; competition from pharmaceutical companies, outsourcing facilities and pharmacies; general economic and business conditions, including inflation and supply chain challenges; regulatory and legal risks and uncertainties related to our pharmacy operations and the pharmacy and pharmaceutical business in general; physician interest in and market acceptance of our current and any future formulations and compounding pharmacies generally.

可能导致实际结果与预测结果不同的一些潜在风险和不确定性包括与以下相关的风险：流动性或经营成果；我们能够成功实施我们的商业计划，及时或完全开发和商业化我们的产品、候选产品和专有配方，识别和获取其他产品，管理我们的药房运营，偿还债务，获得运营业务所需的融资，招聘和留住合格人员，管理我们可能经历的任何增长，并成功实现我们以前的收购以及我们可能追求的任何其他收购和合作安排的好处；来自制药公司、外包设施和药店的竞争；总体经济和商业状况，包括通货膨胀和供应链挑战；与我们的药房运营以及整个药房和制药业务相关的监管和法律风险以及不确定性；医生对我们目前和任何未来的配方和复合药房的兴趣和市场接受程度。

These and additional risks and uncertainties are more fully described in Harrow’s filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K an.

这些以及其他风险和不确定性在哈罗向美国证券交易委员会提交的文件中得到了更充分的描述，包括其10-K an表格的年度报告。

About VEVYE® (cyclosporine ophthalmic solution) 0.1%

关于VEVYE®（环孢素眼用溶液）0.1%

VEVYE (cyclosporine ophthalmic solution) 0.1%, non-preserved, for topical ophthalmic use. Approved by the U.S. Food and Drug Administration (FDA) in June 2023, VEVYE combines a semifluorinated alkane eyedrop technology (perfluorobutylpentane) with cyclosporine 0.1% in solution. VEVYE is indicated to treat both the signs and symptoms of DED.

VEVYE（环孢素眼用溶液）0.1%，未保存，用于局部眼科使用。VEVYE于2023年6月获得美国食品和药物管理局（FDA）的批准，它将半氟化烷烃滴眼液技术（全氟丁基戊烷）与溶液中0.1%的环孢菌素结合在一起。VEVYE适用于治疗DED的体征和症状。

Clinical trials for VEVYE have demonstrated that it not only increases tear production, but it also has been shown to improve the cornea surface as evidenced by total corneal fluorescein staining (tCFS). Clinical trials also show that VEVYE’s clinical benefits begin as early as 15 days and show sustained improvement over 12 months – all while maintaining an excellent patient tolerability and low adverse event profile..

VEVYE的临床试验表明，它不仅可以增加泪液的产生，而且还可以改善角膜表面，如总角膜荧光素染色（tCFS）所证明的。临床试验还表明，VEVYE的临床益处最早从15天开始，并在12个月内持续改善，同时保持了良好的患者耐受性和较低的不良事件特征。。

INDICATIONS AND USAGE

适应症和用法

VEVYE is indicated for the treatment of the signs and symptoms of dry eye disease.

VEVYE适用于治疗干眼症的体征和症状。

CONTRAINDICATIONS

禁忌症

None.

没有。

WARNINGS AND PRECAUTIONS

警告和注意事项

Potential for Eye Injury and Contamination. To avoid the potential for eye injury and/or contamination, patients should not touch the bottle tip to the eye or other surfaces.

眼睛受伤和污染的可能性。为了避免眼睛受伤和/或污染的可能性，患者不应将瓶尖接触眼睛或其他表面。

Use with Contact Lenses. VEVYE should not be administered while wearing contact lenses. If contact lenses are worn, they should be removed prior to administration of the solution. Lenses may be reinserted 15 minutes following administration of VEVYE ophthalmic solution.

与隐形眼镜一起使用。佩戴隐形眼镜时不应使用VEVYE。如果佩戴隐形眼镜，应在服用溶液之前将其取下。在服用VEVYE眼科溶液15分钟后，可以重新插入镜片。

ADVERSE REACTIONS

不良反应

Clinical Trials Experience. Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In clinical trials with 738 subjects receiving at least 1 dose of VEVYE, the most common adverse reactions were instillation site reactions (8%) and temporary decreases in visual acuity (3%)..

临床试验经验。由于临床试验是在差异很大的条件下进行的，因此在一种药物的临床试验中观察到的不良反应率不能直接与另一种药物的临床试验中的不良反应率进行比较，也可能无法反映实践中观察到的不良反应率。在738名受试者接受至少1剂VEVYE的临床试验中，最常见的不良反应是滴注部位反应（8%）和视力暂时下降（3%）。。

USE IN SPECIAL POPULATIONS

用于特殊人群

Pregnancy. There are no adequate and well-controlled studies of VEVYE administration in pregnant women to inform a drug-associated risk.

怀孕。目前还没有关于孕妇服用VEVYE的充分且对照良好的研究来告知与药物相关的风险。

Lactation. Caution should be exercised when VEVYE is administered to a nursing woman.

哺乳期。给哺乳期妇女服用VEVYE时应谨慎。

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

鼓励您向FDA报告处方药的负面副作用。访问www.fda.gov/medwatch，或致电1-800-fda-1088。

For additional information about VEVYE, please see the Full Prescribing Information.

有关VEVYE的更多信息，请参阅完整的处方信息。

1 Pooled study data.

1汇总研究数据。

2 An open-label, single-arm, extension study.

2开放标签，单臂，扩展研究。

3 This offer is available on one fill only, and is valid only for eligible patients paying cash who do not have commercial or government insurance. This offer is not valid for patients with government insurance, including, but not limited to, Medicaid or Medicare. Contact Harrow at 833-442-7769 for information on how to apply for your money-back guarantee.

3此优惠仅适用于一次填写，仅适用于支付现金且没有商业或政府保险的合格患者。此优惠对拥有政府保险（包括但不限于医疗补助或医疗保险）的患者无效。有关如何申请退款担保的信息，请致电833-442-7769与哈罗联系。

Additional terms and conditions apply. This offer is available through any participating retail pharmacy..

其他条款和条件适用。此优惠可通过任何参与的零售药店获得。。

4 Source: Ophthalmology Innovation Source (OIS) Dry Eye Conference (March 2021)

4来源：眼科创新资源（OIS）干眼症会议（2021年3月）

5 By participating in the program, patients acknowledge that they currently meet the eligibility criteria. This program is only available for eligible commercially insured patients who are dispensed VEVYE by PhilRx or another participating pharmacy. This offer is not valid for patients with government insurance, including, but not limited to, Medicaid or Medicare.

5通过参与该计划，患者承认他们目前符合资格标准。该计划仅适用于PhilRx或其他参与药房配发VEVYE的符合条件的商业保险患者。此优惠对拥有政府保险（包括但不限于医疗补助或医疗保险）的患者无效。

A patient’s out‑of‑pocket cost may be greater based on patient’s plan benefit design. Additional terms and conditions apply. All patients, including uninsured, commercially insured, and government-insured, may be eligible for manufacturer cash discount pricing subject to program terms and conditions for opt out..

根据患者的计划福利设计，患者的自付费用可能会更高。其他条款和条件适用。所有患者，包括未保险、商业保险和政府保险的患者，都有资格根据计划条款和条件选择退出，享受制造商现金折扣定价。。