DURHAM, N.C., Feb. 26, 2025 (GLOBE NEWSWIRE) -- Opus Genetics, Inc. (Nasdaq: IRD), a clinical-stage ophthalmic biotechnology company developing gene therapies for the treatment of inherited retinal diseases (IRDs) and other ophthalmic disorders, today announced completion of enrollment in the VEGA-3 Phase 3 clinical trial evaluating Phentolamine Ophthalmic Solution 0.75% for presbyopia.

北卡罗来纳州达勒姆，2025年2月26日（环球新闻社）——Opus Genetics, Inc.（纳斯达克股票代码：IRD），一家临床阶段的眼科生物技术公司，致力于开发用于治疗遗传性视网膜疾病（IRDs）及其他眼科疾病的基因疗法，今日宣布已完成VEGA-3第三阶段临床试验的受试者招募，该试验评估0.75%酚妥拉明眼科溶液治疗老花眼的效果。

Opus also announced that enrollment in the LYNX-2 pivotal Phase 3 trial, evaluating Phentolamine Ophthalmic Solution 0.75% for the treatment of visual loss in low light conditions associated with keratorefractive surgery, is well-underway with anticipated completion of enrollment in the first half of 2025.

Opus还宣布，评估0.75%酚妥拉明眼用溶液治疗与角膜屈光手术相关的弱光条件下视力丧失的LYNX-2关键III期试验的入组工作正在顺利进行，预计将在2025年上半年完成入组。

In addition, the FDA has granted Fast Track designation for Phentolamine Ophthalmic Solution 0.75% as treatment of significant chronic night driving impairment with concomitant increased risk of motor vehicle accidents and debilitating loss of best spectacle corrected mesopic vision in keratorefractive patients with photic phenomena (i.e., glare, halos, starburst).

此外，FDA已授予Phentolamine眼用溶液0.75%快速通道资格，用于治疗伴有光现象（即眩光、光晕、星爆）的角膜屈光手术患者中显著的慢性夜间驾驶障碍，以及同时增加的机动车事故风险和最佳眼镜矫正中视力的严重丧失。

Fast track status is designated to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need..

快速通道地位被指定用于促进治疗严重疾病和满足未满足医疗需求的药物的开发并加快其审查进程。

“We are pleased with the ongoing progress of both the VEGA-3 and LYNX-2 studies,” said Jay Pepose, M.D., PhD., Chief Medical Advisor at Opus Genetics. “Presbyopia affects millions of people and represents a daily challenge that can diminish independence and quality of life. Phentolamine Ophthalmic Solution 0.75% has the potential to transform how this condition is managed by offering a durable, non-invasive solution that improves near vision, without compromising nighttime distance vision.

“我们对VEGA-3和LYNX-2研究的持续进展感到满意，”Opus Genetics首席医学顾问Jay Pepose博士表示。“老花眼影响着数百万人，并且代表着一种每日的挑战，可能会削弱独立性和生活质量。0.75%酚妥拉明眼科溶液有潜力通过提供一种持久、非侵入性的解决方案来改变这种状况的管理方式，改善近视力，同时不损害夜间远视力。”

It also offers the potential to improve visual performance in patients who have undergone LASIK for vision correction, and who now have difficulty with low light vision and night-time vision disturbances. We look forward to sharing the results of these important studies and working with our partner to complete development in these two indications.”.

它还提供了改善接受过LASIK视力矫正手术患者的视觉表现的潜力，这些患者目前在低光和夜间视力干扰方面存在困难。我们期待分享这些重要研究的结果，并与我们的合作伙伴共同努力，在这两个适应症上完成开发。”

VEGA-3 Phase 3 Program in Presbyopia

VEGA-3老花眼第三阶段项目

VEGA-3 is a randomized, double-masked, placebo-controlled, multi-center, Phase 3 clinical trial evaluating Phentolamine Ophthalmic Solution 0.75% in 545 participants with presbyopia. The primary endpoint is the percentage of participants with 15-letter improvement in photopic binocular distance-corrected near visual acuity (“DCNVA”) on the eighth day following their first visit.

VEGA-3 是一项随机、双盲、安慰剂对照、多中心的三期临床试验，评估了 545 名老花眼患者使用 0.75% 酚妥拉明眼科溶液的效果。主要终点是首次就诊后第八天，光线下双眼矫正近视力（“DCNVA”）提高 15 个字母的参与者百分比。

Participants are being followed a total of 48 weeks to collect chronic safety data. Recruitment has taken place at 39 investigational sites in the U.S..

参与者总共被随访48周以收集慢性安全性数据。招募工作已经在美国的39个试验地点进行。

For more information on the VEGA-3 trial design and endpoints, please refer to www.ClinicalTrials.gov (NCT06542497).

有关VEGA-3试验设计和终点的更多信息，请访问www.ClinicalTrials.gov（NCT06542497）。

LYNX-2 Phase 3 Program in Dim Light Disturbances

LYNX-2第三阶段计划在微光干扰下的应用

LYNX-2 is a randomized, double-masked, placebo-controlled Phase 3 clinical trial designed to evaluate Phentolamine Ophthalmic Solution 0.75% compared to placebo in subjects who underwent keratorefractive surgery and then reported decreased visual acuity under low light conditions. Target enrollment is 200 subjects, and the trial is more than 95% enrolled.

LYNX-2 是一项随机、双盲、安慰剂对照的 3 期临床试验，旨在评估 0.75% 酚妥拉明眼用溶液与安慰剂在经历角膜屈光手术后报告在低光条件下视力下降的受试者中的效果。目标入组人数为 200 名受试者，目前该试验的入组率已超过 95%。

The primary endpoint is a gain of 3 lines (or 15 letters) or more of distance vision improvement on a low contrast chart in low light conditions after 15 days of dosing..

主要终点是在低光条件下，使用低对比度视力表测量，经过15天的给药后，远视力提高3行（或15个字母）或更多。

The LYNX-2 trial is being conducted under conditions of a Special Protocol Assessment (SPA) with the U.S. FDA. Additional information about LYNX-2 can be found at

LYNX-2试验正在美国FDA的特殊方案评估（SPA）条件下进行。有关LYNX-2的更多信息可以在以下网站找到。

www.clinicaltrials.gov NCT06349759

www.clinicaltrials.gov NCT06349759

.

。

The U.S. FDA recently granted Fast Track designation for Phentolamine Ophthalmic Solution 0.75% as treatment of significant chronic night driving impairment in keratorefractive patients with reduced mesopic vision and photic phenomena. Fast Track designation is an important regulatory milestone with the potential to accelerate the development and review of new drugs intended to treat serious conditions with unmet medical needs.

美国食品药品监督管理局（FDA）近期授予了0.75%酚妥拉明眼用溶液快速通道资格，用于治疗角膜屈光手术后出现中重度夜间驾驶障碍且伴有中光视视力下降和光现象的患者。快速通道资格是一项重要的监管里程碑，有望加速针对未满足医疗需求的重大疾病新药的研发和审评进程。

This designation offers Opus Genetics several key benefits, including more frequent interactions with the FDA, eligibility for Priority Review, as well as rolling review, allowing sections of the NDA to be submitted and evaluated on an ongoing basis..

这一指定为 Opus Genetics 带来了几项关键优势，包括与 FDA 更频繁的互动、优先审查资格以及滚动审查，允许 NDA 的部分文件持续提交和评估。

About Presbyopia

关于老花眼

Presbyopia is the most common age-related ocular condition. It is estimated that 128 million Americans, and over 2 billion people worldwide, have presbyopia, and this number is expected to grow as the population ages. Presbyopia reduces the eye's ability to focus on near objects due to the loss of lens elasticity and its ability to change shape.

老花眼是最常见的眼部老化问题。据统计，美国有一亿两千八百万人，全球有超过二十亿人患有老花眼，并且随着人口老龄化，这一数字预计还会增长。老花眼会因为晶状体弹性减弱及其改变形状的能力下降，降低眼睛注视近处物体时的聚焦能力。

This progressive condition typically affects individuals over the age of 40 and can significantly impact quality of life and ability to perform everyday tasks such as reading, using digital devices, and other close-up activities. Presbyopia leads to the widespread use of reading glasses or bifocals.

这种渐进性疾病通常影响40岁以上的人群，可能会显著影响生活质量以及执行日常任务的能力，例如阅读、使用数字设备和其他近距离活动。老花眼导致了阅读眼镜或双焦点眼镜的广泛使用。

Phentolamine Ophthalmic Solution 0.75% is being developed to provide a non-invasive, convenient alternative to traditional corrective measures..

正在开发0.75%的酚妥拉明眼药水，以提供一种非侵入性、便捷的传统矫正措施的替代方案。

About Decreased Vision in Low Light Conditions after Keratorefractive Surgery

关于角膜屈光手术后在低光照条件下视力下降的问题

Decreased low contrast visual acuity under low light conditions occurs when the pupil dilates in low light conditions allowing peripheral unfocused rays of light to enter the eye, degrading image quality. It is not correctable with glasses and is often accompanied by glare, halos and starbursts at night.

在低光照条件下，当瞳孔在低光下扩张时，允许周边未聚焦的光线进入眼睛，从而降低图像质量，导致低对比度视力下降。这种现象无法通过眼镜矫正，并且常伴有夜间眩光、光晕和星爆现象。

The condition is common in patients with increased peripheral ocular aberrations and ocular scatter from refractive surgery (including LASIK, PRK, SMILE, and RK). There are currently no FDA-approved treatments. Phentolamine Ophthalmic Solution 0.75% has a mechanism of action that moderately reduces pupil size, thereby blocking unfocused peripheral rays of light, without the increased risks of retinal tears or detachment associated with parasympathomimetic miotics that engage the ciliary muscle.

这种情况在因屈光手术（包括LASIK、PRK、SMILE和RK）导致周边眼像差和眼部散射增加的患者中较为常见。目前尚无FDA批准的治疗方法。0.75%酚妥拉明眼用溶液的作用机制是适度缩小瞳孔，从而阻挡未聚焦的周边光线，且不会像作用于睫状肌的拟副交感神经药物那样增加视网膜撕裂或脱离的风险。

It has the potential to be a treatment option that could improve patients’ ability to see, drive and function in low light..

它有可能成为一种治疗选择，可以提高患者在弱光环境下视物、驾驶和活动的能力。

About Phentolamine Ophthalmic Solution 0.75%

关于酚妥拉明眼药水0.75%

Phentolamine Ophthalmic Solution 0.75%, Opus Genetics’ late-stage product candidate, is a non-selective alpha-1 and alpha-2 adrenergic antagonist designed to reduce pupil size. It works by uniquely blocking the alpha-1 receptors found on the radial iris dilator muscles, which are activated by the alpha-1 adrenergic receptors, without affecting the ciliary muscle.

0.75% 酚妥拉明眼用溶液，Opus Genetics 的后期产品候选物，是一种非选择性 α-1 和 α-2 肾上腺素能拮抗剂，旨在缩小瞳孔大小。它通过独特地阻断位于放射状虹膜扩张肌上的 α-1 受体（由 α-1 肾上腺素能受体激活）起作用，且不影响睫状肌。

Phentolamine Ophthalmic Solution 0.75% is being developed for presbyopia and reduced mesopic low contrast and night vision disturbances after keratorefractive surgery..

盐酸酚妥拉明眼用溶液0.75%正在被开发用于治疗老花眼，以及角膜屈光手术后出现的中光低对比度和夜视障碍。

About Opus Genetics

关于Opus遗传学

Opus Genetics is a clinical-stage ophthalmic biotechnology company developing gene therapies to treat patients with inherited retinal diseases (IRDs) and other treatments for ophthalmic disorders. The pipeline includes adeno-associated virus (AAV)-based gene therapies that address mutations in genes that cause different forms of bestrophinopathy, Leber congenital amaurosis (LCA) and retinitis pigmentosa.

Opus Genetics是一家临床阶段的眼科生物技术公司，致力于开发基因疗法以治疗遗传性视网膜疾病（IRDs）及其他眼科疾病的治疗方法。其研发管线包括基于腺相关病毒（AAV）的基因疗法，针对导致不同形式的最佳蛋白病、莱伯先天性黑蒙（LCA）和视网膜色素变性的基因突变。

The company’s most advanced gene therapy program is designed to address mutations in the LCA5 gene, which encodes the lebercilin protein and is currently being evaluated in a Phase 1/2 open-label, dose-escalation trial, with encouraging early data. BEST1 gene therapy is designed to address mutations in the BEST1 gene, which is associated with retinal degeneration; A Phase 1/2 study will be initiated in 2025.

该公司最先进的基因治疗项目旨在解决LCA5基因的突变问题，该基因编码lebercilin蛋白，目前正在进行一项1/2期开放标签、剂量递增试验，早期数据令人鼓舞。BEST1基因疗法旨在解决与视网膜退化相关的BEST1基因突变问题；一项1/2期研究将于2025年启动。

The pipeline also includes Phentolamine Ophthalmic Solution 0.75%, a non-selective alpha-1 and alpha-2 adrenergic antagonist to reduce pupil size, and APX3330, a novel small-molecule inhibitor of Ref-1 to slow the progression of non-proliferative diabetic retinopathy. Phentolamine Ophthalmic Solution 0.75% is currently being evaluated in Phase 3 trials for treatment of presbyopia and reduced dim (mesopic) light low contrast vision following keratorefractive surgery.

该产品线还包括0.75%的酚妥拉明眼科溶液，这是一种非选择性的α-1和α-2肾上腺素能拮抗剂，用于缩小瞳孔；以及APX3330，一种新型的小分子Ref-1抑制剂，用于减缓非增殖性糖尿病视网膜病变的进展。0.75%的酚妥拉明眼科溶液目前正在进行第三阶段临床试验，用于治疗老花眼及角膜屈光手术后在昏暗（中视）光线下对比度低的视力下降问题。

For more information, please visit www.opusgtx.com..

欲了解更多信息，请访问 www.opusgtx.com。

Forward Looking Statements

前瞻性声明

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements concerning expectations regarding our cash runway, data from and future enrollment for our clinical trials, our pipeline of additional indications, expectations of potential growth, and our expectations regarding integration following the acquisition of Opus Genetics, including with respect to the combination of their portfolio of clinical assets into our existing portfolio and our combined focus on gene therapy treatment..

本新闻稿包含1995年《私人证券诉讼改革法案》意义上的前瞻性声明。这些声明包括但不限于关于我们现金跑道的预期、临床试验的数据和未来入组情况、我们其他适应症的管线、潜在增长的预期，以及关于收购Opus Genetics后整合的预期，包括将其临床资产组合整合到我们现有资产组合中，以及我们在基因治疗方面的共同关注。

These forward-looking statements relate to us, our business prospects and our results of operations and are subject to certain risks and uncertainties posed by many factors and events that could cause our actual business, prospects and results of operations to differ materially from those anticipated by such forward-looking statements.

这些前瞻性陈述涉及我们公司、我们的业务前景以及我们的经营成果，并受到许多因素和事件所带来的某些风险和不确定性的制约，这些因素和事件可能导致我们的实际业务、前景及经营成果与这些前瞻性陈述中预期的情况存在重大差异。

Factors that could cause or contribute to such differences include, but are not limited to, those described under the heading “Risk Factors” included in Ocuphire’s Annual Report on Form 10-K. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this report.

可能导致或促成此类差异的因素包括但不限于Ocuphire年度报告Form 10-K中“风险因素”标题下描述的内容。读者应注意不要过度依赖这些前瞻性声明，因为这些声明仅截至本报告的日期有效。

In some cases, you can identify forward-looking statements by the following words: “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “aim,” “may,” “ongoing,” “plan,” “potential,” “predict,” “project,” “should,” “will,” “would” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words.

在某些情况下，您可以通过以下词语识别前瞻性陈述：“预期”、“相信”、“继续”、“可能”、“估计”、“期望”、“意图”、“目标”、“或许”、“正在进行”、“计划”、“潜力”、“预测”、“预计”、“应该”、“将”、“会”或这些术语的否定形式或其他类似表述，尽管并非所有前瞻性陈述都包含这些词语。

We undertake no obligation to revise any forward-looking statements in order to reflect events or circumstances that might subsequently arise..

我们不承担任何义务来修改任何前瞻性声明，以反映可能随后出现的事件或情况。

These forward-looking statements are based upon our current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, including, without limitation:.

这些前瞻性陈述基于我们当前的预期，涉及的假设可能永远不会实现或可能被证明是不正确的。由于各种风险和不确定性，包括但不限于：实际结果和事件的时间可能会与这些前瞻性陈述中预期的有重大差异。

The foregoing review of important factors that could cause actual events to differ from expectations should not be construed as exhaustive. Readers are urged to carefully review and consider the various disclosures made by us in this report and in our other reports filed with the Securities and Exchange Commission that advise interested parties of the risks and factors that may affect our business.

上述可能导致实际事件与预期不同的重要因素的审查不应被视为详尽无遗。我们敦促读者仔细审阅和考虑我们在本报告及向证券交易委员会提交的其他报告中所做的各种披露，这些披露告知相关方可能影响我们业务的风险和因素。

All forward-looking statements contained in this press release speak only as of the date on which they were made. We undertake no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made..

本新闻稿中包含的所有前瞻性陈述仅在其发布之日有效。我们没有义务更新这些陈述以反映在其发布之后发生的事件或存在的状况。

Source: Opus Genetics, Inc.

来源：Opus Genetics, Inc.

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