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Mean intraocular pressure (IOP) reduction from washed-out baseline was 44.6% at Month 12; all patients had IOP reduction >20% and IOP ≤ 18 mmHg.
在第12个月,平均眼压(IOP)从冲洗基线降低了44.6%;所有患者的眼压降低>20%,眼压≤18 mmHg。
100% of patients remained off topical IOP-lowering medications.
100%的患者仍不服用局部降眼压药物。
All eyes achieved Visual Acuity (BCDVA) of 20/40 or better.
所有眼睛的视力(BCDVA)均达到20/40或更高。
ALISO VIEJO, Calif., April 02, 2024 (GLOBE NEWSWIRE) -- SpyGlass Pharma™, a privately-held ophthalmic biotechnology company, announced today 1-year follow up data from a first-in-human study of 23 patients with glaucoma or ocular hypertension implanted with SpyGlass’ Intraocular Lens (IOL) based Drug Delivery Platform with bimatoprost at the time of cataract surgery.
加利福尼亚州ALISO VIEJO,2024年4月2日(环球通讯社)--SpyGlass Pharma™是一家私营眼科生物技术公司,今天宣布了一项首次人体研究的1年随访数据,该研究对23名青光眼或高眼压患者进行了白内障手术时植入了基于SpyGlass人工晶状体(IOL)的药物输送平台和比马前列素。
These data will be highlighted in a poster presentation during the American Society of Cataract and Refractive Surgeons (ASCRS) Annual Meeting, held from April 5-8 in Boston..
这些数据将在4月5日至8日在波士顿举行的美国白内障和屈光外科医生协会(ASCRS)年会上的海报展示中突出显示。。
One year after implantation, the enduring intraocular pressure (IOP) reduction remained consistent across all three dose strengths, achieving a mean pressure reduction of 44.6% at month 12 compared to pre-operative washed-out baseline levels. All patients sustained more than a 20% IOP reduction from baseline and IOPs of ≤18 mmHg through month 12.
植入后一年,在所有三种剂量强度下,持续眼压(IOP)降低保持一致,与术前冲洗基线水平相比,在第12个月时平均眼压降低44.6%。到第12个月,所有患者的眼压均比基线降低了20%以上,眼压≤18 mmHg。
Additionally, 100% of patients remain off topical IOP-lowering drops. The SpyGlass platform was well tolerated and there were no adverse events related to the product..
此外,100%的患者仍然不使用局部降眼压滴剂。SpyGlass平台耐受性良好,没有与产品相关的不良事件。。
“The clinical results, one year after implantation, continue to be highly encouraging for patients living with glaucoma,” said Margot Goodkin, M.D., Ph.D., Chief Medical Officer, SpyGlass Pharma™. “Bimatoprost has provided patients across the globe with safe, highly effective IOP-lowering for over 2 decades.
SpyGlass Pharma™首席医疗官Margot Goodkin医学博士说:“植入后一年的临床结果对青光眼患者来说仍然是非常令人鼓舞的。”。“20多年来,比马前列素为全球患者提供了安全,高效的眼压降低方法。
These data highlight the substantial potential of the SpyGlass Drug Delivery Platform to be a game changer for patients and all cataract surgeons.”.
这些数据突出了SpyGlass药物输送平台成为患者和所有白内障外科医生游戏规则改变者的巨大潜力。”。
“SpyGlass technology has the potential to change the paradigm and improve care for glaucoma patients undergoing routine cataract surgery,” said Patrick Mooney, CEO, SpyGlass PharmaTM. 'There are nearly 5 million annual cataract procedures in the United States, approximately 20% of them are performed in patients with glaucoma or ocular hypertension.
SpyGlass PharmaTM首席执行官帕特里克·穆尼(PatrickMooney)说:“SpyGlass技术有可能改变青光眼患者接受常规白内障手术的模式,改善护理。”美国每年有近500万例白内障手术,其中约20%是在青光眼或高眼压患者中进行的。
The unmet need is significant, and SpyGlass is committed to delivering safe and effective therapeutics via proven implantation techniques to improve the lives of patients living with chronic eye conditions. The compelling clinical data released this week suggest we are on track to bringing our innovative platform to patients.”.
未满足的需求非常重要,SpyGlass致力于通过经验证的植入技术提供安全有效的治疗方法,以改善慢性眼病患者的生活。本周发布的引人注目的临床数据表明,我们正在将创新平台带给患者。”。
The SpyGlass Drug Delivery Platform with bimatoprost is designed to deliver 3 years of bimatoprost to targeted tissues. Patients will continue to be followed over time and the Company plans to share longer-term data in the coming months. SpyGlass is currently enrolling patients in a Phase I/II study in the United States to investigate the safety and efficacy of its platform in a larger patient pool.
带有比马前列素的SpyGlass药物输送平台旨在向靶组织输送3年的比马前列素。随着时间的推移,患者将继续接受随访,该公司计划在未来几个月分享长期数据。SpyGlass目前正在美国进行I/II期研究,以调查其平台在更大患者库中的安全性和有效性。
SpyGlass looks forward to working closely with FDA to advance the program to commercial approval..
SpyGlass期待着与FDA密切合作,推动该计划获得商业批准。。
ABOUT SPYGLASS PHARMA
关于SPYGLASS PHARMA
SpyGlass Pharma was Co-founded by Dr. Malik Y. Kahook, MD and Glenn Sussman. The company is focused on the development of the world’s first, IOL-mounted, controlled release drug delivery platform capable of delivering multiple years of therapy. The technology was originally developed in the Sue Anschutz-Rodgers Eye Center of the University of Colorado School of Medicine and spun off campus post Series A funding from New Enterprise Associates.
SpyGlass Pharma由医学博士MalikY.Kahook博士和GlennSusman共同创立。该公司专注于开发世界上第一个IOL安装的控释药物输送平台,能够提供多年的治疗。这项技术最初是在科罗拉多大学医学院的苏·安舒茨·罗杰斯眼科中心开发的,并从新的企业伙伴那里获得了校外post A系列资金。
http://www.spyglasspharma.com.
http://www.spyglasspharma.com.
Media Contact:
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克劳迪娅·佩尼多
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Cpenido@dna-comms.com
Cpenido@dna-comms.com