Frequency and Intensity of REcurrences in Non-infectious Posterior Uveitis Treated With Fluocinolone Acetonide Implant (FACi): a Multicenter Retrospective Real-world Study

Non-infectious posterior uveitis is a chronic inflammatory eye disease that can lead to irreversible retinal damage and visual impairment due to repeated inflammatory relapses.
The fluocinolone acetonide intravitreal implant is approved for the prevention of inflammatory relapses in this condition, but data from real-world clinical practice remain limited, particularly regarding the intensity of relapses over time.
This multicenter retrospective observational study aims to evaluate the frequency and intensity of inflammatory recurrences in adult patients with non-infectious posterior uveitis treated with a fluocinolone acetonide implant. Clinical and imaging data routinely collected during follow-up will be analyzed over a three-year period to better characterize long-term outcomes, treatment burden, and safety in real-life conditions.

开始日期2026-06-01

申办/合作机构

Nantes University Hospital

NCT06536491

/ Active, not recruiting临床1/2期

A Randomized, Controlled, Subject- and Evaluator-Masked, Phase 2 Clinical Trial Comparing EC-104 Intravitreal Implant to Ozurdex® for the Treatment of Diabetic Macular Edema (BETTIS-1)

This is a prospective, randomized, subject- and evaluator-masked, Phase 2, multicenter study comparing the safety and efficacy of EC-104-6M high-dose (fluocinolone acetonide [FA] 0.14 mg) implant and EC-104-4M low-dose (FA 0.092 mg) implant to Ozurdex® (dexamethasone intravitreal (IVT) implant, 0.7 mg) in subjects with diabetic retinopathy (DR) and center-involving diabetic macular edema (DME), with prior suboptimal clinical response to IVT anti-VEGF therapy who have been previously treated with locally administered corticosteroids without a clinically significant rise in intraocular pressure (IOP).

开始日期2024-08-19

申办/合作机构

Eclipse Life Sciences, Inc.

NCT05592717

/ RecruitingN/AIIT

An Observational Study of YUTIQ (Fluocinolone Acetonide Intravitreal Implant 0.18 mg) for the Management of Chronic Non-infectious Uveitis

This project is designed to evaluate the efficacy of YUTIQ® 0.18 mg intravitreal implant for the management of chronic non-infectious uveitis.

开始日期2023-01-05

申办/合作机构

天津医科大学

100 项与氟轻松玻璃体内植入剂相关的临床结果

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100 项与氟轻松玻璃体内植入剂相关的转化医学

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100 项与氟轻松玻璃体内植入剂相关的专利（医药）

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715

项与氟轻松玻璃体内植入剂相关的文献（医药）

2026-11-01·STEROIDS

Menopause-specific associations of organophosphate esters with sex hormones among US women

Article

作者: Fang, Lanlan ; Zheng, Yabing

Organophosphate esters (OPEs) may disrupt hormonal balance, but their specific effects in pre- and post-menopausal women have been underexplored. This investigation delves into the menopause-specific associations of OPEs with sex hormones in the National Health and Nutrition Examination Survey, 2013-2016. We included 817 premenopausal and 657 postmenopausal women. Survey-weighted multivariable linear regression, restricted cubic splines (RCS), principal component analysis (PCA), and quantile-based g computation (qgcomp) models were conducted to investigate the associations of OPE metabolites and OPEs mixture with sex hormones in pre- and postmenopausal women. In postmenopausal women, bis(2-chloroethyl) phosphate (BCEP) and Bis(1,3-dichloro-2-propyl) phosphate (BDCPP) were negatively associated with testosterone (T) (BCEP: β = -0.06 [-0.10, -0.01]; BDCPP: β = -0.07 [-0.13, -0.01]) and free androgen index (FAI) (BCEP: β = -0.08 [-0.13, -0.02]; BDCPP: β = -0.06 [-0.12, -0.01]). Diphenyl phosphate (DPHP) was also negatively associated with FAI (β = -0.08 [-0.14, -0.02]). RCS analyses revealed non-linear exposure-response relationships between DPHP and T, between BDCPP and estrogen (E2), and between BDCPP and DPHP and the T/E2 ratio. PCA and qgcomp analyses consistently found negative associations between the OPEs mixture and T and FAI. Conversely, in premenopausal women, BCEP was linearly and positively associated with sex hormone-binding globulin (SHBG) (β = 0.05 [0.01,0.09]), whereas DPHP showed a nonlinear relationship with SHBG, with a curve rising then plateauing. Overall, OPEs, alone or as mixtures, might lower T and FAI levels in postmenopausal women. In contrast, BCEP and DPHP might increase SHBG levels in premenopausal women.

2026-11-01·AMERICAN JOURNAL OF OPHTHALMOLOGY

Comparative Endophthalmitis Rates of Anti-VEGF, Corticosteroid Implants and Anti-Complement Injections: An IRIS Registry Analysis

Article

作者: Meshkin, Ryan S ; Patel, Nimesh A ; Elze, Tobias ; Chaaya, Celine ; Lorch, Alice C ; Miller, John B ; Miller, Joan W ; Goldberg, Eric A ; Zhang, Yi Stephanie ; Pandiri, Srujay ; Hoyek, Sandra ; Ross, Connor J ; Singh, Rishi

PURPOSE:

To evaluate the incidence of endophthalmitis after intravitreal injections using a large, national ophthalmic registry.

DESIGN:

Retrospective clinical cohort study.

METHODS:

Patients in the American Academy of Ophthalmology IRIS Registry (Intelligent Research in Sight) who received intravitreal injections of anti-vascular endothelial growth factor (VEGF) agents, fluocinolone acetonide (Iluvien, Yutiq), avacincaptad pegol (Izervay), pegcetacoplan (Syfovre), or dexamethasone (Ozurdex) were included in this analysis. Data from pediatric and adult patients in the IRIS Registry who were diagnosed with acute endophthalmitis within 30 days after intravitreal injections from 2016 to 2024 were collected.

RESULTS:

The overall incidence of endophthalmitis in adults was 3.5 per 10,000 cases with rates of 3.3 per 10,000 after anti-VEGF, 4.9 per 10,000 after avacincaptad pegol, 6.6 per 10,000 after pegcetacoplan, 10 per 10,000 and 8 per 10,000 after fluocinolone acetonide (Iluvien and Yutiq, respectively), and 12 per 10,000 after dexamethasone implant. The rate of endophthalmitis was significantly higher for corticosteroid implants and pegcetacoplan compared to anti-VEGF injections. Over the past years, there were statistically significant yet small fluctuations in endophthalmitis incidence for anti-VEGF injections ranging from 2.4 per 10,000 in 2021 to 4 per 10,000 in 2020.

CONCLUSIONS AND RELEVANCE:

The incidence of post-injection endophthalmitis is greater with corticosteroid implants and anticomplement therapies. Heightened aseptic vigilance may be warranted with injections that necessitate larger gauge needles, modulate the immune response and/or are prepared from a vial.

2026-09-10·Nature

Thermally evaporated perovskite/silicon tandems via formamidinium eutectic

Article

作者: Zhang, Xueling ; Luo, Chao ; Shi, Yu ; Meng, Xin ; Li, Nengxu ; Wang, Tao ; Wang, Keli ; Lin, Ming ; Zhang, Xinyu ; Lee, Ling Kai ; Yin, Wan-Jian ; Zhao, Qing ; Zhu, Zihao ; Gao, Peng ; Zhou, Qilin ; Guo, Xiao ; Jiang, Yuhui ; Hou, Yi ; Hu, Jingcong ; Dong, Zijing ; Bai, Sai ; Wang, Xi ; Chen, Jinxi ; Pei, Fengtao ; Jia, Zhenrong ; Luo, Ran ; Chen, Yifeng ; Wei, Jing ; Yan, Cheng ; Chen, Yu ; Mo, Yi ; He, Rui ; Gao, Jifan ; Niu, Xiuxiu ; Yao, Yuxin ; Xie, Zhigang ; Du, Xinyi ; Ma, Yabin ; Guan, Zhen ; Kan, Chenxia ; Wang, Yuduan

Solution processing remains the dominant route to high-performance perovskite/silicon tandems, but it remains challenging to simultaneously achieve industrial scalability and long-term reliability^1-3. Thermal evaporation is more industrially viable, yet it has not been successfully demonstrated for large-area perovskite/silicon tandems, largely due to the thermal degradation of formamidinium iodide (FAI) during high-temperature evaporation. Here we synthesize a formamidinium-based eutectic that lowers the effective evaporation temperature of FAI by an average of 36 °C-below its degradation threshold-thereby enabling stable FAI evaporation without thermal degradation. As a result, the evaporated perovskite films have enhanced crystallinity and atomic-scale compositional homogeneity. Sequentially evaporated perovskite/silicon tandems achieve a steady-state efficiency of 31.5% (1 cm²). Benefiting from the uniformity of evaporation, we further demonstrate a thermally evaporated large-area perovskite/silicon tandem on a commercial half-cut G12 wafer, delivering a steady-state efficiency of 30% (200 cm²). Scaling the device area from 1 cm² to 200 cm² incurs only a 3.99% relative efficiency loss, representing, to our knowledge, the lowest reported efficiency penalty for area scaling in perovskite-based tandems. The eutectic-based tandem retains 95% of its initial efficiency after 2,000 h of damp-heat ageing (85 °C and 85% relative humidity) and has negligible power loss after 2 months of real-world outdoor operation.

173

项与氟轻松玻璃体内植入剂相关的新闻（医药）

2026-10-19

·循因缉药

贝达药业：“猪队友”又崩了，怎么办？在线等

环球视野，深度视角各位亲爱的股东，大家早上好中午好晚上好！古希腊哲学家赫拉克利特说：“人不能两次踏进同一条河流”。然而，可以两次掉进同一个坑。呃...不对，好像不止两次... 这个专门坑合作伙伴的“猪队友”就是EyePoint。 PART 01 “又崩” 2026年10月19日，贝达药业的合作伙伴EyePoint发布公告，其核心资产DURAVYU（EYP-1901，vorolanib玻璃体内植入物）治疗湿性年龄相关性黄斑变性（湿性AMD）的第二项关键性III期临床试验LUCIA未达主要终点。尽管 DURAVYU 治疗组受试者视力有所改善，但在最佳矫正视力（BCVA）较基线的平均变化方面，未能证明其相对于阿柏西普 2mg 对照组的统计学非劣效性。随即，EyePoint公司股价开盘狂泻超80%，又崩了... 要不怎么说西药劲大呢... 那么为什么要说又呢？事实上，这家公司可谓“坑坑洼洼”，除了坑还是坑。 PART 02 “挖坑专业户” DURAVYU的核心成分是伏罗尼布（Vorolanib），最初由贝达药业研发。2020年2月，贝达药业通过其控股子公司Equinox Sciences，将伏罗尼布用于局部眼科治疗的海外权益独家授权给了EyePoint，首付款100万美元，最高5000万美元里程碑付款。这本来很好，钱虽然不多，好歹也算有个进项。好死不死，2022年5月贝达药业与EyePoint又签了《扩大许可协议》，从而获得了DURAVYU在大中华区（包括中国大陆、香港、澳门和台湾）的独家开发和商业化权利。结果您猜怎么着？ 2024年5月6日，EyePoint宣布公司的DURAVYU（EYP-1901）的非增殖性糖尿病视网膜病变关键临床试验未能达到主要终点。 EyePoint表示兄弟别慌，这个适应症不行，咱们还有湿性年龄相关性黄斑变性（wAMD）这个适应症嘛。 2025年7月29日，贝达药业宣布，其战略合作伙伴EyePoint评估DURAVYU治疗湿性年龄相关性黄斑变性（湿性AMD）效果的关键性III期临床试验LUCIA已全部完成患者入组。至此，LUGANO和LUCIA两个关键III期临床全部完成患者入组，前景一片大好。 EyePoint公布DURAVYU治疗湿性年龄相关性黄斑变性（wAMD）的首项关键III期临床试验LUGANO数据，该研究未达成预设主要终点，DURAVYU未实现相对于阿柏西普的非劣效。随即EyePoint股票崩盘，股价暴跌超66%。 EyePoint表示不慌，兄弟不慌，咱还有另外一个临床试验LUCIA。一切都会好起来，2027年中期咱就能向FDA申请NDA（新药上市申请）！然后...就是我们看到的开头那一幕，LUCIA也完了。其实这俩临床设计都没差别，两项试验均按1:1随机分配患者接受DURAVYU 2.7 mg每24周一次，或标签剂量阿柏西普2 mg每八周一次，并根据预先设定标准按需给予补充阿柏西普。这个世界哪有那么多巧合... PART 03 欧康维视：逃过一劫事实上，EyePoint坑的可不止贝达这一个队友。 2020年8月20日，中国药企欧康维视向EyePoint支付了950万美元用以获得商业化YUTIQ和DEXYCU的权利。 2022年6月21日YUTIQ优施莹获得中国NMPA批准上市在国内销售，这也是欧康维视的核心产品。 2024年8月27日，FDA公布了一封针对EyePoint的警告信。在FDA的检查中发现EyePoint生产的YUTIQ存在生产问题，其核心组分存在异常释放率记录，大约0.65微克/天，而其他药物核心的释放率约为0.17-0.28微克/天。 YUTIQ的规格是0.18mg，也就是180ug，根据0.65ug/天的释放速度，大概277天释放完毕。而YUTIQ的设计使用时间是36个月，意味着剩下的两年时间患者将处于未用药治疗的危险状态。更离谱的是，公司的屋顶有3处漏水，而公司的记录中未有任何改进和预防措施。（完整记载见上文）欧康维视表示谢谢...然后表示庆幸。之所以说庆幸，是因为2021年1月4日，欧康维视向EyePoint支付1650万美元获得后者19.9%的股权成为EyePoint的大股东之一，并且欧康维视董事长刘晔获得EyePoint董事席位。好在，2024年1月欧康维视就说已经减持的差不多了，获得5666万美元对价，逃过一劫。 PART 04 “老乡别走” EyePoint还有翻盘的风险吗？有的朋友，包有的。 DURAVYU除了wAMD还有糖尿病性黄斑水肿（DME）这个适应症在临床上，预计2027年底有结果。 III期DME项目包括COMO和CAPRI两项全球、随机、双盲、阿柏西普对照、非劣效性试验，评估DURAVYU 2.7 mg在活动性DME患者中的安全性和有效性。老乡别走啊... 然而，现实也很残酷。为了在当下这个情况下支持该项目的顺利进行，EyePoint将裁员53%，预计节省3000万年化开支，2026Q4完成。讽刺的是，EyePoint刚拿下了Biospace 2026年最佳小企业雇主不久。 PART 05 最后我要是贝达的话，我肯定是有点慌的。不为别的，就怕大家瞎想。你说，EyePoint这么多临床都失败了，不会是核心成分伏罗尼布不行吧？所以，求求了，DME的临床一定要成功啊... 好了，今天的瓜就先吃到这里，明天的瓜我们明天再吃，散会！ END 各位股东看了么？赞了么？转发了么？别忘了点赞。谢谢！所有内容均不作为投资建议，信息均来自公开资料，星球更新更快。扫码加入星球！循因缉药Elite PS:风里雨里，老编等你（联系我扫下面二维码）~ 近期原创：搞蛋白组真的能赚钱啊硕世生物控制权争夺进入第二阶段不是刚买过吗？Labcorp 7.22亿美元现金又又又收购BioReference 部分业务 15亿美元轻松拿捏！阿斯利康牵手AI制药公司insitro 所以这5000个样本的空间生物学大项目花落谁家？相关资料：注1：https://investors.eyepoint.bio/news-releases/news-release-details/eyepoint-announces-topline-results-lucia-second-pivotal-phase-3 注2：https://investors.eyepoint.bio/news-releases/news-release-details/eyepoint-announces-strategic-prioritization 注3：https://investors.eyepoint.bio/news-releases/news-release-details/eyepoint-announces-topline-data-lugano-first-two-pivotal-phase-3

临床3期引进/卖出临床成功

2026-10-19

·丁香园 Insight 数据库

眼科新王者，正在浮出水面

眼科药物已经成长为不容小觑的黄金赛道。从雷珠单抗、阿柏西普的商业化成功，到法瑞西单抗的爆发式增长，这一市场的潜力不断得到验证。广阔的市场前景，吸引了默沙东、礼来、艾伯维等制药巨头扎堆布局。近期，默沙东的 MK-8748（EYE201，Tiespectus）和 Remigromig（EYE103/MK-3000）更是接连迎来关键临床节点，眼科管线布局进一步提速。中国市场同样热闹非凡，单抗、双抗、多肽、基因治疗等技术路线密集涌现，信达生物、再鼎医药、欧康维视等众多药企纷纷囤积弹药，试图抢占下一轮增长红利。眼科市场，天花板仍在抬高一款眼科药物，究竟能做到多大的商业体量？罗氏与诺华合作开发的雷珠单抗、拜耳与再生元联合开发的阿柏西普，先后成长为年销售额达数十亿美元的重磅产品，销售峰值分别为 43 亿美元和 96.47 亿美元。罗氏新一代抗 VEGF 药物法瑞西单抗，更是仅用四年时间年销售额便突破 50 亿美元，照此速度，未来或有望突破百亿美元大关，重新定义眼科药物的天花板。来源：丁香园 Insight 数据库一代又一代眼科药物销售额持续走高，无疑证明了这一赛道的含金量。根据弗若斯特沙利文数据，2020 年全球眼科市场规模已达到 327 亿美元，2030 年更是有望超过 700 亿美元。值得注意的是，雷珠单抗、阿柏西普和法瑞西单抗的成功，都与视网膜疾病治疗需求密切相关。三者的获批适应症涉及湿性年龄相关性黄斑变性（AMD）、糖尿病黄斑水肿（DME）、视网膜静脉阻塞（RVO）继发黄斑水肿、脉络膜新生血管（CNV）等多种致盲性眼底疾病。眼科疾病种类繁多，常见的眼科疾病包括屈光不正（近视、远视）、干眼症、白内障、青光眼、视网膜病/眼底疾病、葡萄膜炎等。其中，视网膜疾病占眼病患者人数的比重较低，但由于存在致盲风险，诞生了多款重磅大药，成为全球眼科药物市场中规模最大、增速最快的核心细分赛道。来源：信达证券研报青光眼是全球首位不可逆性致盲眼病，尽管占眼病患者人数比重较低，但也诞生了多款知名药物，包括艾伯维以 630 亿美元收购艾尔建获得的贝美前列素（Bimatoprost）、诺华的曲伏前列素（Travoprost）、辉瑞的拉坦前列素（latanoprost）。相较之下，干眼症患者数量庞大，全球有超过 3 亿患者，但市场的天花板却相对有限。目前只有 Restasis（0.05% 环孢素滴眼液）跨过 10 亿美元门槛，于 2016 年达到销售额峰值，为艾尔建带来了约 14.88 亿美元的全球收入，但随后因专利到期和仿制药入场，销售额出现明显下滑。另一边，诺华曾以 53 亿美元拿下 Xiidra（利非司特滴眼液，5%），但销售峰值却不到 5 亿美元，之后打包出售给博士伦（Bausch + Lomb）。不过，一些新兴的干眼症药物也展现出强劲的增长潜力，例如博士伦的 MIEBO（全氟己基辛烷滴眼液，0.1%），在 2025 年大卖 3.16 亿美元，并将峰值销售预期从 5 亿美元上调至超过 6 亿美元。巨头加码，押注下一款超级大药在多款重磅大药的加持下，视网膜疾病赛道早已成为 MNC 必争的金矿。尤其是默沙东，以 30 亿美元收购 EyeBiotech 获得了 Tiespectus、Remigromig 等潜在重磅药物，看点十足。 Tiespectus 是全球首创的 Tie-2/VEGF 双抗，正在开展头对头对比阿柏西普治疗 DME 患者的 III 期临床，以及头对头对比阿柏西普治疗湿性血管性年龄相关性黄斑变性（wAMD）的 II/III 期临床。 Remigromig 是一款靶向 LRP5 和 FZD4 的三抗，也是 20 年来首个在关键研究中取得非劣效于抗 VEGF 疗法结果的眼科全新机制药物、首个披露关键研究数据的眼科三抗药物。II/III 期 BRUNELLO 研究结果显示，针对未接受过治疗的 DME 患者，治疗第 52 周，Remigromig 组患者的 BCVA 评分改善效果非劣效于雷珠单抗组，并且耐受性更好。另外，基因疗法凭借长效给药优势，展现出不俗的潜力，并吸引了礼来、艾伯维等巨头重金布局。来源：丁香园 Novent 礼来收购 Adverum 获得的 Ixo-vec（ADVM-022），公布了 5 年长期随访数据：单次玻璃体腔注射可实现湿性 AMD 长效管控，患者 5 年内抗 VEGF 注射频次下降 87%，黄斑结构指标持续改善，视力稳定维持，且无远期安全风险。目前该药已处于 Ⅲ 期阶段。艾伯维和 ReGenXBio 合作开发的 Sura-vec（ABBV-RGX-314），已公布治疗 wAMD（视网膜下注射）适应症 5 年和糖尿病视网膜病变（DR）（微创脉络膜上腔注射）适应症 2.5 年随访结果，单次给药有望实现长效疾病控制，摆脱患者长期频繁注射抗 VEGF 药物的沉重负担，并预计今年第四季度读出 III 期 ATMOSPHERE 和 ASCENT 研究数据。 4D 公司和大冢制药合作开发的 4D-150，针对 wAMD 患者已展现出单次注射、两年长效控病、超七成治疗减负、零新增安全风险的优异表现，目前针对 wAMD 和 DME 患者已处于 III 期临床。而在青光眼领域，也有新型降眼压药物涌现。Nicox 的 NCX470（OT-301，格贝前列素）已向 FDA 递交上市申请，Ⅲ 期研究结果显示其在开角型青光眼和高眼压症中非劣效于 0.005% 拉坦前列素；印度 SPARC 公司的 PDP-716 为每日一次的溴莫尼定滴眼液制剂，已向 FDA 提交上市申请。安斯泰来的基因疗法 ASP2767 处于 I/II 期研究，尝试通过保护视网膜神经细胞延缓疾病进展。来源：丁香园 Insight 数据库另外，为应对阿柏西普专利到期，拜耳收购 Perfuse Therapeutics 获得了一款内皮素受体拮抗剂 PER-001。该药采用缓释、可溶解的植入体，每六个月注射一次，注入眼后部（玻璃体内），目前已完成治疗 DR 和开角型青光眼的 Ⅱ 期临床，有望成为首个针对两种眼病的「疾病修饰疗法」（即针对疾病根本病因而非仅缓解症状），颠覆传统降眼压疗法。在干眼症领域，Oculis 的 Licaminlimab（OCS-02）已进入临床 II/III 期，有望成为全球首个基于基因型开发的干眼症精准治疗药物，改变现有环孢素类和利非司特类抗炎治疗方案。国内药企，谁能率先突围？把视线拉回中国，市场呈现存量跨国垄断与增量在研本土多极分散的「剪刀差」特征：商业化存量高度集中于诺华、爱尔康、参天制药、艾伯维等跨国药企；而在研增量呈现本土专科药企（欧康维视、兴齐眼药、兆科眼科）、综合龙头（信达生物、康弘药业、恒瑞医药）与前沿 Biotech（维眸生物、中因科技、纽福斯等）三方角逐的多极分化态势。根据 Insight 数据库，目前国内临床在研眼科新药管线超 200 款，重点适应症覆盖湿性 AMD、湿性 AMD、AMD、DME、青光眼等。从技术来看，国内眼科管线正由小分子化药和一代抗体向双抗（ANGPT2×VEGF）、AAV 体内基因治疗、CRISPR 基因编辑及 siRNA 快速演进。中国眼科创新药研发全景与阶段分布图片来源：丁香园 Novent 一些代表性眼科差异化管线，备受市场关注。已上市产品方面，信达生物的替妥尤单抗 N01 是国内首个甲状腺眼病（TED）靶向生物药；恒瑞医药引进的两款干眼症药物 SHR8058（全氟己基辛烷滴眼液）和环孢素滴眼液（IV，SHR8028），均基于 EyeSol 无水无防腐剂平台开发；欧康维视引进的 OT-401（氟轻松玻璃体内植入剂），是首款经 FDA 批准可释放氟轻松长达 36 个月的慢性非感染性葡萄膜炎（NIU-PS）疗法。在研管线方面，信达生物的全球首创双特异性重组全人源融合蛋白依莫芙普-α注射液（IBI302，VEGF×C3b/C4b 双靶融合蛋白）、欧康维视治疗干眼全新靶点（First-in-class）1 类新药 OT-202（Syk/VEGFR-2 双靶点抑制剂），均已处于临床 III 期。此外，中因科技/天泽云泰的哌普锐基（ZVS101e）单次给药改善视力，有望成为全球首个针对结晶样视网膜变性（BCD）的基因治疗产品；本导基因的全球首个体内基因编辑抗病毒的基因治疗产品 BD111，正在开展治疗单纯疱疹病毒性角膜炎的 II 期研究。结语罗氏、拜耳等携重磅大药证明了眼科药物赛道的潜力，默沙东、礼来、艾伯维等 MNC 正试图用前沿疗法把门踹得更开。与此同时，国内药企也在多条技术路线上排兵布阵，以求抓住下一轮增长红利。参考资料： 1. 各家公司的财报、公告、官微 2. 丁香园 Insight 数据库 3. 丁香园 Novent 4. 东北证券、信达证券、国海证券研报编辑：月牙封面来源：站酷海洛免责声明：本文仅作信息分享，不代表 Insight 立场和观点，不构成任何投资建议，也不作治疗方案推荐和介绍。如有就医需求，请咨询和联系正规医疗机构

并购专利到期生物类似药

2026-10-16

·BioSpace

Eclipse Life Sciences Announces Positive Topline Results from Phase 2 BETTIS-1 Study Evaluating EC-104 for Diabetic Macular Edema (DME)

RESEARCH TRIANGLE PARK, N.C., Oct. 15, 2026 (GLOBE NEWSWIRE) -- Eclipse Life Sciences, Inc. , a privately held clinical-stage biopharmaceutical company developing next-generation therapies for retinal diseases, today announced positive topline results from its BETTIS-1 Phase 2 clinical trial comparing EC-104 fluocinolone acetonide (FA) extended release versus Ozurdex® for the treatment of diabetic macular edema (DME). EC-104 is a novel, completely biodegradable intravitreal corticosteroid implant engineered to deliver approximately six months of durable drug release. The BETTIS‑1 trial met its primary endpoint, demonstrating a favorable safety pro both EC-104 formulations compared to Ozurdex®. Secondary endpoints showed superior clinically meaningful and durable improvement in both best corrected visual acuity and OCT central subfield thickness at 24 weeks, when compared to Ozurdex®. The superiority of EC-104 was demonstrated in a study population of subjects with a previous suboptimal response to anti-VEGF therapy, which represents a significant unmet need and commercial opportunity. “These results position EC-104 as a highly competitive candidate in the DME landscape,” said Scott Cousins, MD, CEO and VP for Research and Development at Eclipse Life Sciences . “The six-month durability, consistent anatomical response, and strong safety pro EC-104’s potential to meaningfully reduce treatment burden. EC-104 continues to show promise as a differentiated corticosteroid option for patients who need longer lasting treatment. We believe these data support advancement into Phase 3 and create a compelling opportunity for strategic collaboration.” Phase 2 BETTIS-1 Topline Findings Primary Endpoint Achieved: EC-104 demonstrated a favorable safety pro low rates of treatment-related adverse events and no unexpected safety signals. Durable Anatomical Response: Both EC-104 formulation groups showed sustained reductions in central subfield thickness (CST) through 24 weeks, consistent with the implant’s six-month release profile. Clinical Benefit in Anti-VEGF-Resistant Subjects: Subjects with documented suboptimal response to prior anti-VEGF therapy exhibited clinically meaningful anatomical improvements, reinforcing EC-104’s potential role as an alternative treatment. Intraocular Pressure (IOP) Profile: Patients with prior corticosteroid tolerance maintained acceptable IOP outcomes in both formulation arms. “These results highlight the potential of EC-104 to reduce treatment burden for patients who struggle with frequent injections and insufficient response to anti-VEGF therapies,” said Victor H. Gonzalez, MD , retina specialist and Founder, Gulf Coast Eye Institute in McAllen, Texas. “An authentic six-month sustained release intravitreal corticosteroid option will be a significant advancement for this population.” Strategic Opportunity With strong Phase 2 data and a well-defined path for late-stage clinical development, regulatory approval and commercialization, Eclipse Life Sciences is exploring partnership opportunities to accelerate Phase 3 initiation and global commercialization. EC-104’s pro it as a differentiated entrant in the multi-billion-dollar DME market where durability and efficacy drive adoption. Next Steps Eclipse Life Sciences plans to engage with regulatory authorities to discuss Phase 3 development of EC-104 and expects to initiate a pivotal program in 2027. Full BETTIS-1 data will be presented at an upcoming ophthalmology conference and will be submitted for publication in a peer-reviewed journal. About Diabetic Macular Edema (DME) DME is the leading cause of vision loss among working-age adults. Although standard of care is initiating treatment with anti-VEGF therapies, many patients experience suboptimal response and require alternative treatments. Intravitreal corticosteroids play a critical role in addressing neuroinflammatory pathways in DME. About Eclipse Life Sciences, Inc. Eclipse Life Sciences is a clinical-stage biopharmaceutical company focused on developing innovative therapies for ophthalmic diseases. In addition to EC-104, Eclipse is advancing EC-303 for intermediate dry age-related macular degeneration (AMD) and EC-501, a six-month anti-VEGF therapy candidate for wet AMD, DME, and macular edema following retinal vein occlusion (RVO). Investigational product. Not approved by regulatory authorities. For media inquiries: info@eclipselifesciences.com Forward Looking Statements: This press release contains forward looking statements. Actual results may differ materially from those expressed or implied by such statements. Factors that could cause actual results to differ include clinical trial outcomes, regulatory decisions, and market conditions.

临床结果

100 项与氟轻松玻璃体内植入剂相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	C05AA10 S02BA08 S01BA15	-

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
葡萄膜炎	美国	EyePoint, Inc.	2018-10-12
糖尿病性黄斑水肿	美国	Alimera Sciences, Inc.	2014-09-26
非感染性后葡萄膜炎	美国	Bausch & Lomb, Inc.	2005-04-08

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
后葡萄膜炎	临床3期	美国	ANI Pharmaceuticals, Inc.	2022-10-05
前葡萄膜炎	临床3期	中国	欧康维视生物医药（上海）有限公司	2019-10-29
前葡萄膜炎	临床3期	中国	EyePoint, Inc.	2019-10-29
中间葡萄膜炎	临床3期	印度	EyePoint, Inc.	2015-06-02

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


EURETINA2025	N/A	葡萄膜炎	61	Iluvien intravitreal implant	繭構憲窪淵鬱構壓積窪(廠襯憲繭膚膚繭醖願鏇) = Mean BCVA at last follow up improved by 0.2 LogMar in patients who had better than counting fingers (CF) vision pre-Iluvien. In the patients with CF BCVA; 66% improved to 0.1 LogMar. 糧鹹鹽蓋醖艱齋廠鏇鹹 (鏇鹹選鑰顧窪夢築製鑰 )	积极	2025-09-04
EURETINA2025	N/A	糖尿病性黄斑水肿	40	ILUVIEN	構鏇獵糧窪膚網鏇襯憲(淵構顧顧衊糧鹽網齋餘) = 願獵餘淵蓋願鑰蓋醖膚鑰顧築構選廠繭襯鹹範 (廠醖糧鬱簾範淵築壓獵, 15.8) 更多	积极	2025-09-04
EURETINA2025	N/A	糖尿病性黄斑水肿	20	Iluvien (Fluocinolone Acetonide) intravitreal implant (Diabetic Macular Oedema with prior poor/suboptimal response to Ozurdex)	齋鹽窪鹹構餘襯膚鬱積(顧簾衊夢鹽積構鬱製遞) = 蓋淵獵積製鏇鹹獵蓋獵簾襯襯製醖觸膚願醖網 (遞觸鏇鹹範鏇鏇壓壓壓 )	积极	2025-09-04
EURETINA2025	N/A	糖尿病性黄斑水肿	21	ILUVIEN	蓋築壓衊廠襯鬱醖範網(壓積構積齋衊遞願製鏇) = 糧蓋鹹遞壓選夢鹹遞壓衊積鑰衊壓遞鹹廠構齋 (範製築製餘網鬱範憲壓 ) 更多	积极	2025-09-04
ARVO2025	N/A	葡萄膜炎 \| 低眼压	24	Boston Type 1 Keratoprosthesis (Kpro) with fluocinolone acetonide intravitreal 0.59 mg implant (Retisert)	艱範糧廠衊鏇願壓網齋(願廠積醖鹽構鏇鹹製窪) = 積糧網選襯繭顧壓繭廠憲構廠鬱廠襯糧襯醖鏇 (製淵製遞範網觸簾膚醖 )	积极	2025-05-04
NCT02746991 (phase III, Pubmed \| Ophthalmol Sci)	临床3期	非感染性后葡萄膜炎	153	Fluocinolone acetonide implant	憲齋網構壓選願夢窪繭(構衊積鹽顧積願壓選獵) = 憲選襯鬱鑰範觸鹹壓醖窪廠鏇鬱積鹹觸襯獵憲 (齋壓顧選觸鏇鹹鏇夢窪 ) 更多	积极	2024-01-01
NCT02746991 (phase III, Pubmed \| Ophthalmol Sci)	临床3期	非感染性后葡萄膜炎	153	Fluocinolone Acetonide Intravitreal Implant (Sham injection)	憲齋網構壓選願夢窪繭(構衊積鹽顧積願壓選獵) = 齋蓋願範鏇範築窪構襯窪廠鏇鬱積鹹觸襯獵憲 (齋壓顧選觸鏇鹹鏇夢窪 ) 更多	积极	2024-01-01
IRISS, RIVER, PALADIN, REALFAc (EURETINA2023)	临床4期	糖尿病性黄斑水肿	103	Fluocinolone acetonide intravitreal implant	鏇蓋壓願憲艱獵襯願衊(鏇醖獵鬱廠網蓋鬱蓋觸) = 簾齋窪鏇艱遞襯簾醖積艱鹹鬱憲襯積構製鑰膚 (築簾窪艱範襯鬱膚憲壓, 20) 更多	积极	2023-10-05
CALM (ARVO2023)	临床4期	非感染性后葡萄膜炎	122	0.18 mg fluocinolone acetonide intravitreal implant	獵選鹹餘繭艱網鏇繭衊(鏇醖簾築願鏇鑰糧築構) = 壓繭遞壓遞廠獵選簾繭鑰醖築糧夢範齋艱觸選 (夢顧願蓋鏇觸鹹繭襯築 ) 更多	-	2023-04-23
NCT02424019 (PALADIN, EURETINA2022 \| NEWS) 人工标引	临床4期	糖尿病性黄斑水肿	159	0.19 mg FAc implant	鑰鹽獵鬱餘遞糧艱鹽蓋(憲壓蓋鏇膚醖膚壓齋壓) = 遞積鬱衊鑰顧繭膚壓鬱鑰餘繭窪膚蓋醖醖選淵 (遞願齋憲夢鹽顧醖夢積 ) 更多	积极	2022-09-01
EURETINA2022	N/A	糖尿病性黄斑水肿	-	Fluocinolone acetonide intravitreal implant	範醖淵衊網製簾鹽壓觸(襯選簾糧構餘鬱範糧鑰) = 40% of the eyes received IOP-lowering medication 網製糧膚鬱鹽膚築蓋齋 (鬱醖鹹選選襯壓壓鑰鑰 ) 更多	-	2022-09-01