NASHVILLE, Tenn.--(BUSINESS WIRE)--Harrow (Nasdaq: HROW), a leading North American eyecare pharmaceutical company, today announced that as of July 1, 2024, it has entered into an agreement with Apexus to make IHEEZO® (chloroprocaine hydrochloride ophthalmic gel) 3% and other Harrow products available through its 340B Prime Vendor Program.

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IHEEZO, indicated for ocular anesthesia, is a low-viscosity topical ocular anesthetic gel with reliable efficacy, a proven safety profile, and simple administration. Other Harrow products available through the program include VIGAMOX®, a topical eye drop for bacterial conjunctivitis, and ILEVRO®, an ocular nonsteroidal anti-inflammatory (NSAID) topical eye drop for pain and inflammation..

IHEEZO适用于眼部麻醉，是一种低粘度局部眼部麻醉凝胶，具有可靠的功效，经证实的安全性和简单的给药方式。该计划提供的其他哈罗产品包括用于治疗细菌性结膜炎的局部滴眼液VIGAMOX®，以及用于治疗疼痛和炎症的眼部非甾体抗炎（NSAID）局部滴眼液ILEVRO®。。

In commenting on the agreement, Mark L. Baum, Chairman and Chief Executive Officer of Harrow, said, “We believe the value this agreement provides to eligible participants will open access to IHEEZO for the U.S. hospital market. According to the U.S. Centers for Disease Control and Prevention, approximately 2.4 million annual emergency room visits in U.S.

哈罗董事长兼首席执行官马克·鲍姆（Mark L.Baum）在评论该协议时表示：“我们相信，该协议为符合条件的参与者提供的价值将为美国医院市场开放IHEEZO。根据美国疾病控制和预防中心的数据，美国每年约有240万急诊室就诊。

hospitals are due to eye-related problems, including the removal of foreign bodies and other acute conditions, many of which require anesthetizing the eye. Consistent with our commitment to ensure access and affordability to our products, with around 44% of U.S. hospitals participating in the Apexus 340B Prime Vendor Program, we are thrilled about the potential benefits we see from our new relationship, especially for vulnerable populations.”.

医院是由于眼部相关问题，包括异物取出和其他急性疾病，其中许多需要麻醉眼睛。与我们确保产品的可获得性和可负担性的承诺一致，约44%的美国医院参与了Apexus 340B主要供应商计划，我们对新关系带来的潜在好处感到兴奋，特别是对弱势人群。”。

The 340B Prime Vendor Program, managed by Apexus, is a contract awarded by the Health Resources and Services Administration (“HRSA”), an agency of the U.S. Department of Health and Human Services, which is responsible for administering the 340B Drug Pricing Program. As the Prime Vendor, Apexus contracts with manufacturers and distributors to help ensure access to discounted medications, provides 340B education to all stakeholders, and helps support program integrity through technical assistance..

由Apexus管理的340B主要供应商计划是由美国卫生与公众服务部的卫生资源与服务管理局（“HRSA”）授予的合同，该机构负责管理340B药物定价计划。作为主要供应商，Apexus与制造商和分销商签订合同，以帮助确保获得折扣药物，为所有利益相关者提供340B教育，并通过技术援助帮助支持项目的完整性。。

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 North American market. Harrow helps eyecare professionals preserve the gift of sight by making its portfolio of prescription and non-prescription pharmaceutical products accessible and affordable to millions of patients each year.

哈罗公司（纳斯达克股票代码：HROW）是一家领先的眼科制药公司，致力于北美市场创新眼科药物产品的发现、开发和商业化。哈罗帮助眼科护理专业人员保护视力，使其处方药和非处方药产品组合每年可供数百万患者使用并负担得起。

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

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都可能被视为“前瞻性陈述”。前瞻性陈述基于管理层当前的预期，并且存在风险和不确定性，可能导致结果与本文所载陈述存在重大不利差异。

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；我们有能力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，识别和收购其他产品，管理我们的制药业务，偿还债务，获得经营业务所需的融资，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利益；来自制药公司、外包设施和药店的竞争；；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.

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About IHEEZO® (chloroprocaine hydrochloride ophthalmic gel) 3%

关于IHEEZO®（盐酸氯普鲁卡因眼用凝胶）3%

IHEEZO is a sterile, single-patient‑use, physician‑administered, ophthalmic gel preparation, containing no preservatives, that is safe and effective for ocular surface anesthesia.

IHEEZO是一种无菌的，单次患者使用，医生管理的眼科凝胶制剂，不含防腐剂，对眼表麻醉安全有效。

IHEEZO was approved by the FDA on September 26, 2022.

IHEEZO于2022年9月26日获得FDA批准。

Clinical trials of IHEEZO demonstrated that patients treated with IHEEZO did not require any supplemental treatment to complete the intended surgical procedure.

IHEEZO的临床试验表明，接受IHEEZO治疗的患者不需要任何补充治疗即可完成预期的外科手术。

IHEEZO represents the first approved use in the U.S. ophthalmic market of chloroprocaine hydrochloride and the first branded ocular anesthetic approved for the U.S. ophthalmic market in nearly 14 years.

IHEEZO是近14年来在美国眼科市场上首次批准使用盐酸氯普鲁卡因的药品，也是美国眼科市场上首次批准使用的品牌眼用麻醉剂。

IHEEZO is protected by an Orange Book-listed patent that is valid until 2038.

IHEEZO受到橙皮书所列专利的保护，该专利有效期至2038年。

INDICATIONS AND USAGE

适应症和用法

IHEEZO™ is indicated for ocular surface anesthesia.

IHEEZO™适用于眼表麻醉。

CONTRAINDICATIONS

禁忌症

IHEEZO™ is contraindicated in patients with a history of hypersensitivity to any component of this preparation.

IHEEZO™禁用于对该制剂的任何成分有超敏反应史的患者。

WARNINGS AND PRECAUTIONS

警告和注意事项

IHEEZO™ should not be injected or intraocularly administered. Patients should not touch the eye for at least 10 to 20 minutes after using an anesthetic as accidental injuries can occur due to insensitivity of the eye. Prolonged use of a topical ocular anesthetic may produce permanent corneal opacification and ulceration with accompanying visual loss.

IHEEZO™不应注射或眼内给药。患者在使用麻醉剂后至少10至20分钟内不应触摸眼睛，因为眼睛不敏感可能会导致意外伤害。长期使用局部眼麻醉剂可能会产生永久性角膜混浊和溃疡，并伴有视力丧失。

Do not touch the dropper tip to any surface as this may contaminate the gel. IHEEZO™ is indicated for administration under the direct supervision of a healthcare provider. IHEEZO™ is not intended for patient self-administration..

不要将滴管尖端接触任何表面，因为这可能会污染凝胶。IHEEZO™适用于在医疗保健提供者的直接监督下进行管理。。。

ADVERSE REACTIONS

不良反应

The most common adverse reaction is mydriasis (approximately 25%).

最常见的不良反应是瞳孔散大（约25%）。

For complete product information about IHEEZO®, including important safety information, please visit: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ea3b2d2c-8b33-d199-e053-2995a90a699c.

有关IHEEZO®的完整产品信息，包括重要的安全信息，请访问：https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ea3b2d2c-8b33-d199-e053-2995a90a699c。

About VIGAMOX® (moxifloxacin hydrochloride ophthalmic solution) 0.5%:

关于VIGAMOX®（盐酸莫西沙星眼用溶液）0.5%：

INDICATIONS AND USAGE

适应症和用法

VIGAMOX® is a topical fluoroquinolone anti-infective indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms: Corynebacterium species*, Micrococcus luteus*, Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus haemolyticus, Staphylococcus hominis, Staphylococcus warneri*, Streptococcus pneumoniae, Streptococcus viridans group, Acinetobacter lwoffii*, Haemophilus influenzae, Haemophilus parainfluenzae*, and Chlamydia trachomatis..

VIGAMOX®是一种局部使用的氟喹诺酮类抗感染药物，用于治疗由以下生物的易感菌株引起的细菌性结膜炎：棒状杆菌*、黄体微球菌*、金黄色葡萄球菌、表皮葡萄球菌、溶血葡萄球菌、人葡萄球菌、华纳葡萄球菌*、肺炎链球菌、绿色链球菌群、lwoffii不动杆菌*、流感嗜血杆菌、副流感嗜血杆菌*和沙眼衣原体。。

*Efficacy for this organism was studied in fewer than 10 infections.

*在不到10次感染中研究了该生物体的功效。

IMPORTANT SAFETY INFORMATION

重要安全信息

Contraindications

禁忌症

VIGAMOX® is contraindicated in patients with a history of hypersensitivity to moxifloxacin, to other quinolones, or to any of the components in this medication.

VIGAMOX®禁用于对莫西沙星，其他喹诺酮类药物或该药物中任何成分过敏的患者。

Warnings and Precautions

警告和注意事项

Hypersensitivity Reactions – Hypersensitivity and anaphylaxis have been reported with systemic use of moxifloxacin.

超敏反应-据报道，全身使用莫西沙星会引起超敏反应和过敏反应。

Prolonged Use – May result in overgrowth of non-susceptible organisms, including fungi.

长期使用-可能导致非敏感生物（包括真菌）过度生长。

Avoid Contact Lens Wear – Patients should not wear contact lenses if they have signs or symptoms of bacterial conjunctivitis.

避免佩戴隐形眼镜-如果患者有细菌性结膜炎的体征或症状，则不应佩戴隐形眼镜。

Adverse Reactions

不良反应

The most frequently reported ocular adverse events were conjunctivitis, decreased visual acuity, dry eye, keratitis, ocular discomfort, ocular hyperemia, ocular pain, ocular pruritus, subconjunctival hemorrhage, and tearing. These events occurred in approximately 1%-6% of patients.

最常报告的眼部不良事件是结膜炎，视力下降，干眼症，角膜炎，眼部不适，眼部充血，眼部疼痛，眼部瘙痒，结膜下出血和撕裂。这些事件发生率约为1%〜6%。

Nonocular adverse events reported at a rate of 1%-4% were fever, increased cough, infection, otitis media, pharyngitis, rash, and rhinitis.

报告的非眼部不良事件发生率为1%〜4%，包括发烧，咳嗽增加，感染，中耳炎，咽炎，皮疹和鼻炎。

For complete product information about VIGAMOX®, including important safety information, please visit: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ad783689-2b59-448c-b0d6-e8b70cf8b062.

有关VIGAMOX®的完整产品信息，包括重要的安全信息，请访问：https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ad783689-2b59-448c-b0d6-e8b70cf8b062。

About ILEVRO® (nepafenac ophthalmic suspension) 0.3%

关于ILEVRO®（nepafenac眼用混悬液）0.3%

ILEVRO® (nepafenac ophthalmic suspension) 0.3%, a nonsteroidal, anti-inflammatory eye drop indicated for pain and inflammation associated with cataract surgery.

ILEVRO®（nepafenac眼用混悬液）0.3%，一种非甾体抗炎滴眼液，适用于白内障手术相关的疼痛和炎症。

INDICATIONS AND USAGE

适应症和用法

ILEVRO® 0.3% is indicated for the treatment of pain and inflammation associated with cataract surgery.

ILEVRO®0.3%用于治疗白内障手术相关的疼痛和炎症。

CONTRAINDICATIONS

禁忌症

ILEVRO® 0.3% is contraindicated in patients with previously demonstrated hypersensitivity to any of the ingredients in the formula or to other nonsteroidal anti-inflammatory drugs (NSAIDs).

ILEVRO®0.3%禁用于先前对配方中任何成分或其他非甾体类抗炎药（NSAIDs）过敏的患者。

WARNINGS AND PRECAUTIONS

警告和注意事项

Increased Bleeding Time. With some NSAIDs including ILEVRO® 0.3%, there exists the potential for increased bleeding time due to interference with thrombocyte aggregation. There have been reports that ocularly applied nonsteroidal anti-inflammatory drugs may cause increased bleeding of ocular tissues (including hyphema) in conjunction with ocular surgery.

出血时间延长。对于包括ILEVRO®0.3%在内的一些非甾体抗炎药，由于干扰血小板聚集，有可能增加出血时间。有报道称，眼部应用非甾体类抗炎药可能会导致眼部手术时眼组织（包括前房出血）出血增加。

It is recommended that ILEVRO® 0.3% be used with caution in patients with known bleeding tendencies or who are receiving other medications which may prolong bleeding time..

对于已知出血倾向或正在接受其他可能延长出血时间的药物治疗的患者，建议谨慎使用0.3%的ILEVRO®。。

Delayed Healing. Topical NSAIDs including ILEVRO® 0.3%, may slow or delay healing. Topical corticosteroids are also known to slow or delay healing. Concomitant use of topical NSAIDs and topical steroids may increase the potential for healing problems.

延迟愈合。局部NSAIDs（包括0.3%的ILEVRO®）可能会减缓或延迟愈合。外用皮质类固醇也可以减缓或延迟愈合。同时使用局部NSAIDs和局部类固醇可能会增加愈合问题的可能性。

Corneal Effects. Use of topical NSAIDs may result in keratitis. In some susceptible patients, continued use of topical NSAIDs may result in epithelial breakdown, corneal thinning, corneal erosion, corneal ulceration, or corneal perforation. These events may be sight threatening. Patients with evidence of corneal epithelial breakdown should immediately discontinue use of topical NSAIDs including ILEVRO® 0.3% and should be closely monitored for corneal health..

角膜效应。使用局部非甾体抗炎药可能导致角膜炎。。这些事件可能会威胁视力。有角膜上皮破裂证据的患者应立即停止使用局部非甾体抗炎药，包括0.3%的ILEVRO®，并应密切监测角膜健康。。

Postmarketing experience with topical NSAIDs suggests that patients with complicated ocular surgeries, corneal denervation, corneal epithelial defects, diabetes mellitus, ocular surface diseases (e.g., dry eye syndrome), rheumatoid arthritis, or repeat ocular surgeries within a short period of time may be at increased risk for corneal adverse events, which may become sight threatening.

局部非甾体抗炎药的上市后经验表明，患有复杂眼部手术，角膜去神经支配，角膜上皮缺损，糖尿病，眼表疾病（例如干眼症），类风湿性关节炎或短期内重复眼部手术的患者可能会增加角膜不良事件的风险，这可能会威胁视力。

Topical NSAIDs should be used with caution in these patients. Postmarketing experience with topical NSAIDs also suggests that use more than 1 day prior to surgery or use beyond 14 days post-surgery may increase patient risk and severity of corneal adverse events..

这些患者应谨慎使用局部非甾体抗炎药。局部非甾体抗炎药的上市后经验还表明，手术前1天以上使用或手术后14天以上使用可能会增加患者风险和角膜不良事件的严重程度。。

Contact Lens Wear. ILEVRO® 0.3% should not be administered while using contact lenses.

隐形眼镜磨损。使用隐形眼镜时不应服用0.3%的ILEVRO®。

ADVERSE REACTIONS

不良反应

Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to the rates in the clinical studies of another drug and may not reflect the rates observed in practice.

由于临床研究是在差异很大的条件下进行的，因此在药物临床研究中观察到的不良反应率不能直接与另一种药物临床研究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。

Serious and Otherwise Important Adverse Reactions. The following adverse reactions are discussed in greater detail in other sections of labeling: (1) Increased Bleeding Time, (2) Delayed Healing and (3) Corneal Effects.

严重和其他重要的不良反应。以下不良反应在标记的其他部分中进行了更详细的讨论：（1）出血时间增加，（2）愈合延迟和（3）角膜效应。

Ocular Adverse Reactions. The most frequently reported ocular adverse reactions following cataract surgery were capsular opacity, decreased visual acuity, foreign body sensation, increased intraocular pressure, and sticky sensation. These reactions occurred in approximately 5 to 10% of patients. Other ocular adverse reactions occurring at an incidence of approximately 1 to 5% included conjunctival edema, corneal edema, dry eye, lid margin crusting, ocular discomfort, ocular hyperemia, ocular pain, ocular pruritus, photophobia, tearing and vitreous detachment.

眼部不良反应。白内障手术后最常报告的眼部不良反应是囊膜混浊，视力下降，异物感，眼压升高和粘滞感。这些反应发生在大约5%至10%的患者中。发生率约为1%至5%的其他眼部不良反应包括结膜水肿，角膜水肿，干眼症，眼睑边缘结痂，眼部不适，眼部充血，眼部疼痛，眼部瘙痒，畏光，撕裂和玻璃体脱离。

Some of these reactions may be the consequence of the cataract surgical procedure..

其中一些反应可能是白内障手术的结果。。

Non-Ocular Adverse Reactions. Non-ocular adverse reactions reported at an incidence of 1 to 4% included headache, hypertension, nausea/vomiting, and sinusitis.

非眼部不良反应。报告的非眼部不良反应发生率为1%至4%，包括头痛，高血压，恶心/呕吐和鼻窦炎。

For complete product information about ILEVRO®, including important safety information, please visit: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=10f411d3-a81e-074a-e063-6294a90ab547.

有关ILEVRO®的完整产品信息，包括重要的安全信息，请访问：https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=10f411d3-a81e-074a-e063-6294a90ab547。