SpyGlass Ophthalmics, Inc

几十年来，在青光眼和其他慢性眼病的治疗过程中，“如何让患者坚持每日滴药”成为眼科疾病治疗的一大痛点，独立于患者行为的药物输送方法几乎成为了整个行业的共同需求。而与之相矛盾的则是在相关创新技术方面仍有巨大需求未得到充分满足。由SpyGlass Pharma研发的SpyGlass药物输送平台的问世则将有效解决这一问题。SpyGlass Pharma是一家专注于开发治疗眼科疾病的创新药物输送方案的企业，总部位于美国加利福尼亚州的亚里索维耶荷市，其愿景是帮助所有白内障外科医生恢复白内障患者的视力，并在同一手术中提供可持续多年的降低眼压治疗。2019年，SpyGlass Pharma由Glenn Sussman创立。Glenn Sussman在眼科领域拥有30多年的经验以及60多项美国专利，这些专利涉及的领域从人工晶状体到眼科手术器械。另一位联合创始人Malik Y. Kahook是一位执业眼科医生和连续创业者，在研发方面拥有15年的创业和学术经验。Glenn和Kahook都认识到，青光眼的手术治疗已经几十年没有取得突破性进展，因此他们一直强烈地渴望为其创新做出贡献。为此，他们开始着手解决眼科护理中最大的难题之一——患者普遍存在的治疗依从性差的问题，并将“持续的长期药物输送”作为努力实现的专一目标。于是，SpyGlass药物输送平台应运而生。由SpyGlass Ophthalmics孵化，专注于开发眼科药物输送平台SpyGlass Pharma 是由SpyGlass Ophthalmics孵化成立的，其母公司SpyGlass Ophthalmics是一家私营的眼科治疗公司，开发旨在改善患者视力和眼部护理的眼科设备。其设备解决了白内障、晶状体置换、手术和其他慢性眼科疾病方面未被满足的需求，使患者能以可承受的成本获得优质的眼科治疗。SpyGlass Ophthalmics创立其分支SpyGlass Pharma的目的是充分利用其在眼科领域的专业知识和资源开拓新的市场空间，即长期眼科药物输送。Malik Y. Kahook表示：“我们知道，很多患者在大多数情况下都不会坚持使用处方的局部治疗药物，原因有多种，包括烧灼感、刺痛、视力模糊等不良反应，无法正确地将药水滴到眼睛上以及健忘等。”因此，其确立了“创建一个可提供持续数周甚至数年的药物输送平台”的目标，这一目标落地转化后便是SpyGlass药物输送平台。SpyGlass药物输送平台的目标是为青光眼或高眼压患者提供不间断且能持续多年的比马前列素治疗，以降低眼压。比马前列素具有较高的安全性和有效性，该活性药物的所有已知安全信息都已很好地转化为临床试验，被认为是目前降IOP（眼压）作用最强的局部抗青光眼药物。其对正常人、POAG（原发性开角型青光眼）和OHT（高眼压症）患者均有效，主要用于不能耐受其他降IOP药或使用其他降IOP药物无效的POAG或OHT患者。除了比马前列素之外，SpyGlass药物输送平台的药物洗脱垫经过独特设计具有多功能性，还将有可能治疗多种眼部疾病，包括慢性葡萄膜炎和黄斑变性等。解决患者依从性难题SpyGlass药物输送平台是第一个也是唯一一个适用于所有白内障外科医生的控释药物输送平台，同时也是世界上第一个安装在IOL（人工晶状体）上的控释药物输送平台，能够实现持久的眼内药物输送治疗。它由单件式疏水性丙烯酸IOL和两个药物洗脱垫组成，可以在常规白内障手术期间直接植入囊袋中。这些药物洗脱垫可以滑动到IOL的每个支架上，并在支架连接处牢固地固定。药物垫牢固连接后，IOL和药物洗脱垫被装入标准IOL注射器中，通过一个小于2.4毫米的切口注射并植入囊袋。药物垫保持在视轴之外，持续地向房水释放活性药物，房水再将活性药物带到靶组织。青光眼作为一种慢性疾病，其护理过程中最重要的部分之一便是坚持治疗。如果患者不坚持药物治疗可能会导致并发症、疾病进展和视力丧失。而SpyGlass药物输送平台则可以有效解决患者依从性的问题，使眼科医生能够确保患者常年坚持治疗。SpyGlass药物输送平台可以稳定和持久地提供药物释放，避免药物浓度的波动和副作用，且不需要患者每天滴眼药水或服用其他药物，为改善患者护理和治疗结果提供了新的可能。同时，疏水性丙烯酸IOL材料已使用数十年，比马前列素也已用作治疗青光眼的局部疗法数十年，为SpyGlass药物输送平台的安全性与可靠性奠定了基础。同时，SpyGlass药物输送平台可以使用标准的IOL注射器进行植入，不需要额外的手术步骤或设备，并且与现有的IOL技术兼容，不影响白内障手术的效果和安全性，实现了将安全、持久的治疗与世界上最常见的常规眼科手术相结合。SpyGlass Pharma联合创始人兼总裁、医学博士Malik Y. Kahook博士表示：“SpyGlass药物输送平台的出现代表了青光眼等眼病治疗的范式转变。”所有治疗组的平均眼压降低45%,将继续推进多项美国临床试验在芝加哥举行的2022年美国眼科学会年会上的Eyecelerator创新会议上公布了一项新发现——SpyGlass药物输送平台的首次人体试验的3个月数据表明，它可以降低开角型青光眼或OHT患者的IOP。在这项人体试验中，共有23名接受白内障手术的患者被随机分配使用SpyGlass药物输送平台，并接受三剂比马前列素中的一剂。3个月后，各组的IOP平均降低了45%，所有患者的IOP均达到18mmHg或更低，无需额外治疗。研究人员指出，此次试验没有报告明显的不良事件，并且与市售人工晶体相比，视力结果相似。而SpyGlass Pharma首次人体青光眼治疗试验的6个月的新数据表明，在白内障手术时植入SpyGlass药物输送平台6个月后，所有治疗组的平均眼压降低了45%，且100%的受试者在植入后9个月停止了所有局部用药。2023年7月10日，SpyGlass Pharma完成9000万美元的C轮融资，以推进青光眼和其他慢性眼科疾病的新疗法，融资将支持SpyGlass药物输送平台进行多项美国临床试验。此轮融资由专门从事生命科学和药物开发领域的投资顾问公司RA Capital Management领投，Vertex Ventures HC、Vensana Capital、Samsara BioCapital、New Enterprise Associates参投。据Crunchbase官网披露，经历了3轮融资，目前SpyGlass Pharma的融资总额已达到1.098亿美元。“此轮融资使SpyGlass项目朝着1/2期和3期临床试验以支持美国注册的方向迈出了坚定步伐。”SpyGlass Pharma首席执行官Patrick Mooney表示。SpyGlass药物输送平台目前尚未获得FDA批准用于任何用途。因此，Spyglass Pharma正在进行多项美国临床试验，以评估其平台在治疗青光眼和其他眼科疾病方面的安全性和有效性，并探索其在其他眼科适应症方面的应用潜力。近期推荐声明：动脉网所刊载内容之知识产权为动脉网及相关权利人专属所有或持有。未经许可，禁止进行转载、摘编、复制及建立镜像等任何使用。动脉网，未来医疗服务平台

ALISO VIEJO, Calif., Feb. 03, 2023 (GLOBE NEWSWIRE) -- SpyGlass Pharma, a privately held ophthalmic therapeutics company, released 6-month data from a First-in-Human glaucoma treatment trial showing that its breakthrough drug delivery platform continues to demonstrate significant intraocular pressure (IOP) lowering in patients with glaucoma or ocular hypertension. The data were showcased during an oral presentation by Malik Y. Kahook M.D., at the Glaucoma 360 New Horizons Forum today in San Francisco. “We are very pleased to share updated results from our First-in-Human clinical trial. We continue to see impressive performance with 45% mean IOP reduction across all treatment groups 6 months after implantation of the SpyGlass drug delivery platform at the time of cataract surgery,” said Malik Y. Kahook, M.D., Co-Founder, President and Executive Chairman of the Board at SpyGlass Pharma. “We’ve known for decades that patient adherence to daily drop regimens is an impediment to treating ophthalmic diseases. These data give a clear signal that the SpyGlass drug delivery system is a breakthrough platform technology with real potential to disrupt the way our most effective therapies are administered long-term. The SpyGlass drug delivery platform with bimatoprost is designed to enable every cataract surgeon the ability to provide unprecedented, multi-year glaucoma therapy at the time of routine cataract surgery. This is a potential game changer for ophthalmic patients globally. Every cataract surgeon will be able to use their existing intraocular lens (IOL) implantation technique to both improve vision due to cataracts and deliver multiple years of bimatoprost therapy for patients who also have glaucoma.” The SpyGlass platform, which consists of a single-piece, hydrophobic acrylic IOL and drug-eluting pads securely attached to the haptics of the IOL, is implanted directly into the capsular bag during routine cataract surgery. The lead SpyGlass program is designed to deliver multiple years of bimatoprost therapy to lower IOP in patients with glaucoma or ocular hypertension. (animation available @ ) For the First-in-Human feasibility trial, 23 patients undergoing cataract extraction were randomized to receive one of three doses of bimatoprost using the SpyGlass platform. After six months, mean reduction in IOP across all groups was 45%, without the need for additional therapy. No significant adverse events were reported, and visual outcomes were similar to those achieved with commercially available IOLs. “We continue to be excited about the possibilities to improve the lives of patients. Our vision is to enable all cataract surgeons to restore sight for patients living with cataracts, and to provide years of IOP-lowering therapy within the same procedure,” said Patrick Mooney, Chief Executive Officer of SpyGlass Pharma. “Approximately 1 in 5 patients treated for cataracts in the United States and Western Europe also suffer from glaucoma or ocular hypertension. The SpyGlass platform will empower cataract surgeons with the ability to solve patient adherence challenges associated with chronic use of topical therapy without any significant changes to their standard cataract procedure. The SpyGlass team is busily preparing our Investigational New Drug (IND) submission to the U.S. Food and Drug Administration (FDA). Once cleared, we intend to enroll patients in a US Phase 1/2 combined clinical trial later this year. While our initial program focuses on glaucoma management at the time of cataract surgery, the SpyGlass platform is capable of delivering a number of ophthalmic medications, offering the versatility to potentially treat a variety of eye conditions including chronic uveitis and macular degeneration.” SPYGLASS PHARMA SpyGlass Pharma was co-founded by Malik Y. Kahook, MD and Glenn Sussman in 2019. The company is focused on the development of novel treatments for chronic ophthalmic diseases. The company’s technology was originally developed in the Sue Anschutz-Rodgers Eye Center of the University of Colorado School of Medicine and is funded by New Enterprise Associates and Vensana Capital. For more information please visit: Contacts: dna Communications Angela Salerno-Robin Senior Vice President, Media Relations, Healthcare ASalerno-Robin@dna-comms.com 212-445-8219 Investors: Laurence Watts Gilmartin Group, LLC. laurence@gilmartinir.com 619-916-7620

Data from a First-in-Human feasibility trial to treat glaucoma demonstrated a 45% drop in mean intraocular pressure at 3 months. SpyGlass Pharma presented its innovative drug delivery platform during the Eyecelerator innovation meeting at AAO 2022ALISO VIEJO, Calif., Sept. 29, 2022 (GLOBE NEWSWIRE) -- SpyGlass Pharma, a privately held ophthalmic therapeutics company, today announced 3-month data from a First-in-Human glaucoma treatment trial showing that its breakthrough drug delivery platform lowered intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. The data were showcased during an oral presentation at the Eyecelerator innovation meeting at the American Academy of Ophthalmology annual meeting (AAO 2022) in Chicago. “We are pleased to share the 3-month results from our First-in-Human clinical trial. The SpyGlass drug delivery platform holds great promise for patients living with glaucoma and other chronic eye conditions,” said Malik Y. Kahook, M.D., Co-Founder, President and Executive Chairman of the Board at SpyGlass Pharma. “Our innovative drug delivery platform is designed to enable all cataract surgeons to provide unprecedented multi-year therapy to treat glaucoma and other chronic eye conditions at the time of routine cataract surgery. The initial data are compelling and demonstrate the potential of this new treatment paradigm to significantly improve patient management without compromises.” The SpyGlass platform, which consists of a single-piece, hydrophobic acrylic intraocular lens (IOL) and drug-eluting pads securely attached to the haptics of the IOL, is implanted directly into the capsular bag during routine cataract surgery. The lead SpyGlass program is designed to deliver multiple years of bimatoprost therapy to lower intraocular pressure in patients with glaucoma or ocular hypertension. For the First-in-Human feasibility trial, 23 patients undergoing cataract extraction were randomized to receive one of three doses of bimatoprost using the SpyGlass platform. After three months, mean reduction in IOP across all groups was 45%, and all patients achieved an IOP of 18 mmHg or lower without the need for additional therapy. No significant adverse events were reported, and visual outcomes were similar to those achieved with commercially available IOLs. “The new 3-month results presented at Eyecelerator highlight the value of the SpyGlass platform for the treatment of chronic eye conditions,” said Robert Cionni, M.D., Adjunct Associate Professor at the University of Utah and the John A. Moran Eye Center. “Approximately 20% of cataract procedures each year are performed in patients who also have glaucoma or ocular hypertension. Cataract surgeons are very comfortable with their current procedural techniques. The SpyGlass platform offers unique advantages to other methods; it allows surgeons to maintain their trusted techniques, it does not require new skills to perfect and, most importantly, it finally empowers all eye doctors to ensure patient adherence to therapy over multiple years.” “We are excited about the possibilities for this first-of-its-kind platform, and we are thrilled to unveil initial data on its use in glaucoma patients undergoing cataract surgery,” said Patrick Mooney, Chief Executive Officer of SpyGlass Pharma. “While our initial program focuses on glaucoma management at the time of cataract surgery, the SpyGlass platform is capable of delivering a number of ophthalmic medications, offering the versatility to treat a variety of eye conditions. Current pipeline projects underway for the SpyGlass platform include its use for delivering post-operative steroids and NSAIDs as well as potentially treating chronic uveitis and macular degeneration.” Meetings with both the U.S. Food and Drug Administration and Centers for Medicare and Medicaid Services have taken place, with clear registration and reimbursement pathways established. SpyGlass Pharma plans to file an Investigational New Drug application in the next 6 months and, pending clearance, will begin enrollment of patients in a U.S. Phase 1/2 clinical trial in 2023. SPYGLASS PHARMASpyGlass Pharma was co-founded by Malik Y. Kahook, MD and Glenn Sussman in 2019. The company is focused on the development of novel treatments for chronic ophthalmic diseases. The company’s technology was originally developed in the Sue Anschutz-Rodgers Eye Center of the University of Colorado School of Medicine and is funded by New Enterprise Associates and Vensana Capital. For more information please visit: http://spyglasspharma.com Contacts:dna Communications Angela Salerno-RobinSenior Vice President, Media Relations, HealthcareASalerno-Robin@dna-comms.com212-445-8219 Investors:Laurence WattsGilmartin Group, LLC.laurence@gilmartinir.com619-916-7620