作者: Habibi, Abbas ; Sadda, Srinivas R ; Ip, Michael S ; Chung, Yu-Chien ; Soylu, Ceren ; He, Y E ; Abbasgholizadeh, Rouzbeh ; Nittala, Muneeswar G ; Huang, Yen-Chun ; Chujo, Shinichiro ; Quarta, Alberto ; Alhelaly, Mai

PURPOSE:

To compare longitudinal changes in retinal nonperfusion in diabetic macular edema (DME) patients treated with brolucizumab versus aflibercept over 52 weeks using ultrawidefield fluorescein angiography (UWF-FA) data from the KINGFISHER clinical trial.

DESIGN:

Post hoc analysis from the KINGFISHER trial, (ClinicalTrials.gov Identifier: NCT03917472), a multicenter, masked clinical trial.

PARTICIPANTS:

Out of 517 participants in the KINGFISHER study, 164 had available baseline UWF-FA. Total 43 cases were excluded due to the presence of laser photocoagulation scar, and 30 cases were excluded due to poor image quality leaving a subset of 91 cases for nonperfusion assessment, of which 59 cases were included in the brolucizumab group, and 32 cases were included in the aflibercept group.

METHODS:

Retinal nonperfusion was assessed from UWF-FA images at baseline, 24 weeks, and 52 weeks in patients treated monthly with either brolucizumab or aflibercept therapy. Images were graded by 2 independent graders for nonperfusion areas in 3 retinal regions: the panretina (TAR area), the posterior pole zone (a 15 mm diameter circle centered on the fovea), and the peripheral zone (all areas within the TAR, but outside the 15 mm circle). Nonperfusion index (NPI) was computed in the different retinal regions.

MAIN OUTCOMES MEASURES:

Changes in NPI across follow-up visits were analyzed and compared between the brolucizumab and aflibercept treated groups.

RESULTS:

Over 52 weeks, both brolucizumab and aflibercept demonstrated no statistically significant change in retinal nonperfusion indices across posterior, peripheral, and pan-retinal zones. The mean NPI showed slight numerical increases from baseline at week 52, but differences were not statistically significant (P > .05). Additionally, linear mixed-effects modeling indicated no statistically significant difference in longitudinal NPI changes between both treatment groups (P > .05).

CONCLUSION:

In this treated cohort, NPI did not show a statistically significant change over 52 weeks in eyes receiving monthly brolucizumab or aflibercept, with no statistically significant difference detected between agents. The absence of significant reperfusion despite intensive VEGF inhibition may suggest non-VEGF-mediated mechanisms.

2026-11-01·CANADIAN JOURNAL OF OPHTHALMOLOGY-JOURNAL CANADIEN D OPHTALMOLOGIE

Congestive heart failure and other cardiac adverse events after intravitreal anti-VEGF therapy: a systematic review and meta-analysis

Article

作者: Jhaveri, Aaditeya ; Kaleem, Shayaan ; Kertes, Peter J ; Balas, Michael ; Mihalache, Andrew ; Muni, Rajeev H ; Popovic, Marko M

OBJECTIVE:

To evaluate congestive heart failure (CHF) and other cardiac adverse events (AEs) after intravitreal anti-vascular endothelial growth factor (VEGF) therapy for retinal vascular disease and compare risks across agents.

DESIGN:

A systematic review and meta-analysis.

METHODS:

Registered review (PROSPERO CRD42022302658) searched Ovid MEDLINE, Embase, and the Cochrane Library from January 2005 to February 2024 for randomized controlled trials (RCTs) of intravitreal anti-VEGF therapy for neovascular age-related macular degeneration, diabetic macular edema, or retinal vein occlusion. Eligible trials compared an anti-VEGF agent with sham or another anti-VEGF agent and reported CHF (primary outcome) or other cardiac AEs (secondary outcomes: arrhythmias, heart failure/cardiomyopathy, inflammatory heart disease, ischemic heart disease, or valvular heart disease). Risk of bias was assessed with RoB 2, certainty with GRADE, and random-effects models generated risk ratios (RRs) with 95% confidence intervals (CIs).

RESULTS:

Fourteen reports describing 20 trials (11,803 eyes; mean age 71 ± 12 years; 53% female) were included. CHF was uncommon overall: aflibercept 2.0% (84/4172), ranibizumab 2.2% (25/1158), faricimab 2.3% (44/1926), brolucizumab 2.5% (40/1612), and sham 3.8% (20/524). Ranibizumab did not differ from sham for CHF (RR = 1.53, 95% CI 0.46-5.06), whereas aflibercept was associated with higher CHF risk versus sham in 2 trials (RR = 2.08, 95% CI: 1.03-4.23). No significant CHF differences were detected between aflibercept and brolucizumab, faricimab, or ranibizumab. Other cardiac events were similar across agents.

CONCLUSIONS:

CHF and other AEs after intravitreal anti-VEGF therapy were uncommon in RCTs and comparable across agents. The aflibercept-sham CHF signal was based on limited evidence and should be interpreted cautiously.

2026-11-01·OPHTHALMOLOGY

Access to Intravitreal Anti-VEGF Drugs in Persons with Medicare Advantage Compared with Medicare Fee-For-Service Coverage

Article

作者: Chan, Jennifer ; Vail, Daniel ; Begaj, Tedi ; Parikh, Ravi ; Lum, Flora ; Friedman, Scott ; Williams, George A ; Repka, Michael X

PURPOSE:

To investigate intravitreal anti-VEGF drug use among Medicare Fee-For-Service (FFS) and Medicare Advantage (MA) beneficiaries.

DESIGN:

Retrospective, cross-sectional analysis of de-identified health care data from the American Academy of Ophthalmology's IRIS® Registry (Intelligent Research in Sight) for patient encounters between January 2017 and December 2022.

PARTICIPANTS:

Medicare beneficiaries 65 years of age and older with FFS or MA coverage with continuous insurance enrollment for at least 12 months.

METHODS:

Unique FFS and MA beneficiaries receiving intravitreal anti-VEGF therapy were included. Patients were considered to be treated with a particular drug if more than 50% of the injections for at least 12 months were with that drug. For each anti-VEGF drug, we compared proportions of patients treated (> 50% of the injections) with that drug between FFS and MA groups and calculated the difference in use between the 2 Medicare health care programs.

MAIN OUTCOME MEASURES:

Differences in anti-VEGF drug use between FFS and MA groups.

RESULTS:

Nine hundred thirty thousand four hundred and eleven beneficiaries underwent 12 942 057 intravitreal injections. In the FFS group, aflibercept 2 mg was used most frequently (43.8%; n = 4 271 050), followed by bevacizumab (34.7%; n = 3 382 439), ranibizumab (20.6%; n = 2 008 791), brolucizumab (0.6%; n = 56 728), and faricimab (0.4%; n = 40 729). In the MA group, bevacizumab was used most frequently (45.1%; n = 1 436 151), followed by aflibercept 2 mg (37.8%; n = 1 201 311), ranibizumab (16.5%; n = 524 758), brolucizumab (0.4%; n = 13 406), and faricimab (0.2%; n = 6694). Repackaged bevacizumab (lower cost) was more common in the MA group compared with the FFS group (60.0% vs. 47.0%; difference, 13.0%; 95% confidence interval [CI], 12.8%-13.3%; P < 0.001). Higher-cost drugs were used significantly less often among those with MA compared with FFS coverage, respectively (aflibercept 2 mg, 28.9% vs. 36.6%; difference, -7.7%; 95% CI, -7.9% to -7.4%; P < 0.001), ranibizumab (11.9% vs. 16.8%; difference, -4.9%; 95% CI, -5.0% to -4.7%; P < 0.001), faricimab (0.06% vs. 0.24%; difference, -0.1%; 95% CI, -0.19% to -0.16%); P < 0.001), and brolucizumab (0.12% vs. 0.19%; difference, -0.01%; 95% CI, -0.09% to -0.05%; P < 0.001).

CONCLUSIONS:

Beneficiaries enrolled in MA were less likely to receive higher-cost anti-VEGF drugs, raising concerns about reduced beneficiary access to newer, more expensive anti-VEGF drugs among those with MA coverage.

FINANCIAL DISCLOSURE(S):

Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

282

项与布西珠单抗相关的新闻（医药）

2026-10-27

·顶尖交易

康弘药业（002773）2026三季报七看八问财务分析

分析日期：2026-10-27　｜　数据来源：公司 2026 年三季报（2026-09-30）及 2021-2025 年报，东方财富数据中心 / 公司公告分析框架：饶钢「投入产出双循环 + 七看八问」股票池：四川省板块（注册地四川）一、一句话概括一句话概括：康柏西普（朗沐）的拥有者，营收降12.5%、净利7.8亿降24.1%，88.7%毛利率+6.6%负债率+现金34.3亿，但YTD暴跌49.8%、投资净流出31.9亿。归属：毛利88.7%的眼科药龙头，YTD-49.8% 二、最新财报核心数据（2026 三季报）项目 2026 前三季度同比营业收入 31.72 亿元 -12.48% 归母净利润 7.84 亿元 -24.09% 扣非归母 7.92 亿元 — 毛利率 88.68% — 归母净利率 24.72% — 经营现金流净额 8.12 亿元 — 投资现金流净额 -31.91 亿元 — 资产负债与营运资本资产负债率仅6.59%（全批最低），零有息负债，账面现金34.3亿——占市值174.0亿的19.7%。应收2.7亿仅占营收8.7%（回款极好）、存货4.1亿占13.0%。固定资产21.0亿+在建0.4亿、固资/营收67.3%。净资产94.3亿。三、五年趋势（2021-2025 年报）年度营收(亿) 同比归母(亿) 同比毛利率净利率 ROE(期末) 经营现金流(亿) 资产负债率 2025 45.85 +2.97% 11.63 -2.37% 89.85% 25.36% 12.51% 15.04 6.5% 2024 44.53 — 11.91 — 89.52% 26.75% 13.77% 14.12 7.4% ROE 为期末归母净利/期末归母权益（未年化）。数据源：东方财富 F10 财务报表。四、五期趋势（2025Q3 - 2026Q3）报告期营收(亿) 同比归母(亿) 同比扣非(亿) 毛利率净利率经营现金流(亿) 2026-09-30 31.72 -12.48% 7.84 -24.09% 7.92 88.68% 24.72% 8.12 2026-06-30 21.79 -11.19% 5.65 -22.61% 5.57 88.50% 25.91% 5.40 2026-03-31 10.46 -12.70% 3.08 -23.12% 3.05 88.66% 29.38% 3.44 2025-12-31 45.85 +2.97% 11.63 -2.37% 11.18 89.85% 25.36% 15.04 2025-09-30 36.24 — 10.33 — 10.24 90.33% 28.50% 14.08 单季拆分（累计值相减）：2026-09 Q3 营收 9.92 / 归母 2.19（归母环比 -14.8%）；2026-06 Q2 营收 11.33 / 归母 2.57（归母环比 -16.3%）；2026-03 Q1 营收 10.46 / 归母 3.08（归母环比 +136.4%）；2025-12 Q4 营收 9.61 / 归母 1.30（归母环比 -57.1%）；2025-09 Q3 营收 11.70 / 归母 3.03。五、投入产出双循环解读经营现金流8.1亿 vs 净利7.8亿，净现比1.04（利润全部转现金）；投资净流出31.9亿（大额理财或投资，需核查）、筹资净流出6.47亿（分红），自由现金流-23.8亿。营运资本66.2亿（占营收208.6%），主要是现金。投资净流出31.9亿是本期最大关注点。六、七看逐项 ①盈收：营收31.7亿降12.5%，归母7.8亿降24.1%，毛利率88.7%、净利率24.7%，毛利率是全批最高（创新生物药）。②费用：期间费用率57.6%，其中研发11.2%——销售费用是最大项（眼科药学术推广）。③增长：近三年营收CAGR约-5%，康柏西普受医保降价与竞品（雷珠单抗、阿柏西普、法瑞西单抗）冲击。④业务：生物药（康柏西普眼用注射液「朗沐」）+ 中成药（松龄血脉康等）+ 化学药，康弘药业为眼底病领域龙头。⑤资产负债：负债率6.59%，零有息负债，现金34.3亿，全批最干净。⑥投入产出：WC/营收208.6%（现金厚）、固资/营收67.3%。⑦收益率：年化ROE 11.08%，杜邦看净利率24.7%×周转0.35×权益乘数1.07。七、八问逐项靠什么赚钱：核心产品康柏西普（治疗湿性年龄相关性黄斑变性的抗VEGF融合蛋白），是国内自主研发的眼底病生物药，曾年销超30亿。顺风逆风：顺风是眼底病患者基数增长（老龄化+糖尿病视网膜病变）、适应症拓展（RVO、DME、近视性CNV）；逆风是医保谈判降价、竞品增多（法瑞西单抗双抗）、生物类似药。空间：国内抗VEGF眼底病市场约100亿且持续增长，康柏西普是国产独家。优势：专利保护（至2028年前后）+ 临床数据 + 眼科渠道，护城河是专利与临床壁垒。格局：与诺华（雷珠单抗/布西珠单抗）、拜耳（阿柏西普）、罗氏（法瑞西单抗）竞争，康柏西普是国产唯一。管理层：柯尊洪创始，分红慷慨（2025年度10派7元）。风险：康柏西普增速下滑（营收降12.5%）、医保降价、竞品冲击、投资净流出31.9亿的投向。未来：基准情形全年净利10亿；乐观情形新适应症放量+海外获批，净利12亿；悲观情形竞品挤压，净利8.5亿。八、造假风险扫描（三维检查点）投资现金流31.9亿：投资净流出31.9亿远超经营现金流，需核查是理财、股权投资还是产能，这是本期最大疑点净利 vs 经营现金流：净利7.8亿 vs CFO 8.1亿，净现比1.04，利润全部转现金，质量优秀毛利率88.7%：毛利率为全批最高（生物药特征），需确认成本结转与产品结构零负债与高现金：负债率6.59%、零有息负债、现金34.3亿，无粉饰动机，报表极干净九、同行对比对比维度公司数值恒瑞医药 PE 39 PB 4.5 荣昌生物 PE 亏损 PB 8.0 兴齐眼药 PE 50 PB 8.0 十、估值判断 PE-TTM 17.4倍、PB 1.84倍、市值174.0亿，年初至今-49.8%（全批跌幅第一）。PE 17.4倍对一家毛利率88.7%、净现比1.04、零负债的眼科药企，几乎是全批最便宜的创新药标的。PB 1.84倍对应ROE 11.08%，PB/ROE约0.17。股息率方面，2025年度10派7.00元对应现价18.89元约3.7%。YTD -49.8%的暴跌需要解释：可能是康柏西普增速下滑（-12.5%）与竞品冲击的担忧，也可能是投资净流出31.9亿引发的疑虑。行情与估值快照指标数值最新价 18.89 元当日涨跌 -4.79% 总市值 174.04 亿元 PE-TTM 17.4x PB-MRQ 1.84x 年初至今 -49.77% 十一、风险提示康柏西普营收降12.5%、净利降24.1%，核心产品增长失速；竞品（法瑞西单抗双抗）冲击；医保谈判降价；投资净流出31.9亿的投向不明；YTD -49.8%显示市场对核心产品的担忧。十二、跟踪指标康柏西普季度销售额与市场份额、医保谈判与续约价格、新适应症（RVO/DME）获批与放量、海外临床进展、投资净流出31.9亿的具体投向、研发资本化率、销售费用率。十三、两分钟小结康弘药业是本批70家里最值得研究的「低估值+高质量+大幅下跌」组合：财务上——毛利率88.7%（全批最高）、净利率24.7%、净现比1.04、负债率6.59%、零有息负债、现金34.3亿（占市值19.7%）、股息率约3.7%；估值上——PE仅17.4倍、PB 1.84倍，YTD却暴跌49.8%（全批跌幅第一）。市场为什么这么悲观？核心是康柏西普（朗沐）增长失速：营收降12.5%、净利降24.1%，面对法瑞西单抗等新一代双抗竞品，这个国产独家的抗VEGF药物正在失去独占红利。此外投资净流出31.9亿去向不明，也让市场怀疑。但17.4倍PE对应88.7%毛利率与零负债，安全边际已经相当厚——如果新适应症或海外市场能补上，这就是明显的错杀。

2026-10-22

·医学进行时

AAO 2026视网膜亚专科日｜视网膜领域年度更新：8篇影响临床实践的文献、药物相关眼内炎症与系统用药视网膜毒性

AAO 2026 ·医学进行时编者按2026年10月9日，美国眼科学会（AAO）2026年会视网膜亚专科日在新奥尔良举行。"视网膜领域年度更新"单元由三位讲者完成，直接对应门诊和手术中的常见决策：Jason Hsu 教授梳理了过去一年中改变其临床实践的8篇文献，结论包括 AMD 高遗传风险人群通过生活方式干预可预防56%～60%的进展期 AMD、卒中或心肌梗死后无需暂停抗 VEGF 注射、增殖期糖尿病视网膜病变玻璃体切割术前4～7天注射抗 VEGF 药物的术后复发风险最低；Glenn J. Jaffe 教授总结了玻璃体腔注射药物相关眼内炎症的识别与处理；Jaclyn L. Kovach 教授更新了羟氯喹、戊聚糖多硫酸钠、胰高血糖素样肽-1受体激动剂及部分抗肿瘤药物的视网膜毒性与筛查建议。一、Jason Hsu：过去一年改变临床实践的8篇文献 Hsu 教授指出，大量同行评审论文难以及时进入一线医生的视野，他挑选的是过去一年中实际影响其诊疗习惯的研究，每页幻灯片均附 PubMed 链接二维码。1. 高遗传风险人群：生活方式仍能显著影响 AMD 进展 Seddon 等在 Ophthalmology 发表的前瞻性纵向研究纳入898只遗传风险评分处于最高三分位、基线为早期或中期年龄相关性黄斑变性（AMD）的眼，5年内23%进展为进展期 AMD。在从不吸烟者中，高风险生活方式（BMI≥25、热量摄入高于中位数、绿叶蔬菜<2.7份/周、鱼类<2份/周）者进展期 AMD 发生风险为理想生活方式者的3.3倍（HR 3.3，95% CI 1.8～6.4，P<0.001）；在曾吸烟者中为5.3倍（HR 5.3，95% CI 2.3～11.9，P<0.001）。人群归因风险估算显示，采取理想生活方式可预防56%（从不吸烟者）～60%（曾吸烟者）的进展期 AMD，对地图样萎缩（Geographic Atrophy，GA）的影响强于新生血管型。图1 高遗传风险人群中生活方式与进展期 AMD 的关联（Seddon JM, et al. Ophthalmology, 2026） Hsu 教授据此建议，对尚未进展的患者以及陪同就诊的进展期 AMD 患者家属，可以明确告知：控制体重、合理控制热量摄入、多吃鱼类和绿叶蔬菜，确实可以降低风险。2. AMD 患者饮食建议按分期细化 Keenan 等在 American Journal of Ophthalmology 发表的综述提出：地中海饮食适用于各期干性 AMD；中期 AMD 应重点强调鱼类摄入（每周2次及以上）；GA 患者应重点增加蔬菜和水果摄入，这与 GA 扩展减缓的关联最为明显。AREDS2 配方补充剂适用于中期及进展期 AMD，对中心凹外 GA 患者可延缓病变向中心凹扩展。Hsu 教授强调，AREDS2 补充剂与健康饮食是互补关系，不能互相替代。3. 卒中或心肌梗死后可继续抗 VEGF 治疗 Weng 团队在 JAMA Ophthalmology 发表的回顾性队列研究基于 TriNetX 电子病历网络，比较了心血管事件前14天至事件后6周内接受过抗血管内皮生长因子（Vascular Endothelial Growth Factor，VEGF）注射的患者，与事件前后3个月内均未注射的患者。倾向评分匹配后，卒中组1526对、心肌梗死组1523对。围事件期注射与死亡率或致残率升高无关；卒中后1年死亡风险 RR 0.52（95% CI 0.43～0.63），心肌梗死后1年死亡风险 RR 0.58（95% CI 0.49～0.68），阿柏西普、贝伐珠单抗、雷珠单抗之间无差异。Hsu 教授的结论是，近期发生卒中或心肌梗死的患者可以继续按计划注射。图2 卒中或心肌梗死围事件期抗 VEGF 注射与系统结局的森林图（Bordbar DD, et al. JAMA Ophthalmol, 2026）需要注意的是，该研究为观察性研究，围事件期注射组死亡风险更低的结果不宜解读为抗 VEGF 治疗具有心脑血管获益，其意义在于未发现安全性信号。4. 水溶性氯己定可替代聚维酮碘用于注射前消毒 Storey 团队在 Ophthalmology Retina 报告了单中心302,474次抗 VEGF 注射的数据：5%聚维酮碘组疑似注射后眼内炎发生率为0.022%（1/4529），0.05%水溶性氯己定组为0.014%（1/7057），P=0.34；培养阳性病例分别为10例和0例（P=0.25）。 Hsu 教授表示，考虑到部分患者对聚维酮碘刺激感耐受差，他已将较多患者改用水溶性氯己定，术后电话咨询和复诊明显减少。5. 糖尿病玻璃体切割术前抗 VEGF：4～7天为最佳间隔中山大学中山眼科中心赵秀娟、卢林团队在 Ophthalmology Retina 发表的竞争风险分析纳入608只因增殖期糖尿病视网膜病变（Proliferative Diabetic Retinopathy，PDR）行玻璃体切割术的眼，其中508只术前接受抗 VEGF 注射，按注射至手术间隔分为1～3天、4～7天、8～14天和>14天四组。以>14天为参照，4～7天组术后玻璃体积血或牵拉性视网膜脱离（Tractional Retinal Detachment，TRD）复发风险最低（HR 0.52，95% CI 0.30～0.88，P=0.015）；间隔超过14天者术后 TRD 风险最高。各组视力结局无显著差异。图3 PDR 玻璃体切割术前抗 VEGF 注射时机与术后复发风险（Zhan J, et al. Ophthalmol Retina, 2026） Hsu 教授据此将术前4～7天视为抗 VEGF 注射的最佳时间窗。6. 眼内气体配比错误：一项可以避免的医疗差错 Gaurav Shah 等在 Ophthalmology Retina 发表的短篇报告汇总了眼科医疗责任保险公司（OMIC）的12起因气体配比错误引发的诉讼，患者最终视力普遍很差，平均赔付金额接近50万美元。Hsu 教授据此在术中增加了"第二次暂停核对"：开灯后再配气，确认气体种类与浓度，由医生目视器械护士完成稀释，或由医生操作、护士监督；注射器内气体推至的位置有时可见弯月面，可作为二次核对依据。7. 第一眼视网膜裂孔，对侧眼格子样变性无需预防性激光 Hsu 团队在 Ophthalmology Retina 发表的回顾性队列研究纳入802例双眼格子样变性、首眼因视网膜裂孔接受治疗的患者，平均随访5.2年。对侧眼接受预防性激光组（83眼）与观察组（719眼）新发裂孔或孔源性视网膜脱离的复合终点发生率分别为24.1%和24.9%（P=0.87），孔源性视网膜脱离发生率分别为6%和5%（P=0.603）。他提醒，两组风险均不低，对侧眼仍需规律随访。图4 对侧眼预防性激光与观察组的视网膜脱离及裂孔累积发生曲线（Ni RL, et al. Ophthalmol Retina, 2026）8. "无滴眼液"玻璃体切割术加州大学圣迭戈分校 William R. Freeman 团队在 Retina 杂志报告：玻璃体切割术结束时玻璃体腔注射去溶剂曲安奈德（5 mg）和莫西沙星（500 μg），与术后常规局部用药的历史对照相比，前房炎症更轻、中央子野厚度更低、黄斑囊样水肿发生率更低（P<0.001），术后6个月最佳矫正视力提高20个字母（对照组8个字母，P=0.01）；两组眼压相近，均未发生眼内炎。Hsu 教授认为，这一方案有助于减轻患者负担和费用、提高满意度，值得尝试。二、Glenn J. Jaffe：药物相关眼内炎症的识别与处理 Jaffe 教授指出，随着生物制剂、基因治疗和小分子药物用于视网膜疾病，治疗相关眼内炎症越来越受到重视。这类炎症可能危及视力，也会影响医生和患者对药物的接受度。在分类上，药物相关眼内炎症可表现为前葡萄膜炎、中间葡萄膜炎、后葡萄膜炎或全葡萄膜炎，可伴或不伴视网膜血管炎及血管闭塞，需与内源性炎症、给药操作相关反应及感染性眼内炎鉴别。他特别指出，只有血管闭塞而没有炎症表现，不能诊断为血管炎。影像评估采用多模影像：超广角眼底照相与荧光素血管造影（Fluorescein Angiography，FA）优先，因为炎症体征常超出后极部；FA 显示渗漏但可能遮蔽血管，OCTA 显示血流但不显示渗漏，两者互补。OCT 上的玻璃体或视网膜内高反射点可能是炎症的早期征象。Jaffe 教授所在的阅片中心已建立标准化的预设影像变量，用于药物上市后监测和临床试验评估。不同药物的炎症表现有一定规律。布西珠单抗（brolucizumab）相关炎症多在数次注射、数月后出现，后段炎症前可先有前房或玻璃体细胞，可出现局灶性视网膜变白、血管炎或血管闭塞。pegcetacoplan 相关炎症多在首次注射后发生，较为罕见，临床试验中未观察到，上市后才被报告，可表现为类似万古霉素相关出血性闭塞性视网膜血管炎（Hemorrhagic Occlusive Retinal Vasculitis，HORV）的闭塞性血管炎，可导致视力丧失。对法瑞西单抗在糖尿病黄斑水肿和 nAMD 关键试验中的眼内炎症事件进行盲法、多模影像标准化复核后，未发现固定模式，也未见血管炎或闭塞性血管炎，上市后有少数病例报告。图5 布西珠单抗相关眼内炎症的典型特征治疗按解剖部位选择：前节炎症强化局部糖皮质激素；玻璃体炎症或急性血管炎使用全身或局部糖皮质激素；转为慢性时可考虑抗代谢药或生物制剂等免疫治疗。怀疑药物相关炎症时应停用该药，Jaffe 教授不建议再次激发试验，应换用其他药物；注射前对可疑病例应先做仔细的裂隙灯检查。他认为未来需要统一的报告标准和治疗路径，对即将上市的基因治疗等新药做好炎症谱特征描述，并开发经过验证的眼内炎症与葡萄膜炎生活质量量表。三、Jaclyn L. Kovach：系统用药相关视网膜毒性更新羟氯喹：OCT 成为主要筛查工具 AAO 于2025年发布羟氯喹视网膜病变筛查建议修订版。Kovach 教授强调的要点包括：OCT 联合广角眼底自发荧光（FAF）为主要筛查手段，视野和多焦视网膜电图为确认性检查；24-2C 等新视野程序可同时筛查中心凹旁和中心周围区域，这一点很重要，因为欧洲裔患者多表现为中心凹旁型损害，东亚裔患者多表现为中心周围型损害。推荐剂量仍为≤5.0 mg/kg/d（按实际体重）。除剂量和疗程外，合并肾病、使用他莫昔芬、高龄起始用药，以及 AMD 等影响筛查判读的黄斑疾病，均为需要关注的危险因素。图6 AAO 羟氯喹视网膜病变筛查建议（2025修订版）要点戊聚糖多硫酸钠：累积剂量是最主要危险因素自2018年首个病例系列报告以来，长期使用戊聚糖多硫酸钠与特征性色素性黄斑病变的关联已得到确认。累积剂量是最主要的危险因素，病理改变为视网膜色素上皮和光感受器损伤以及内层脉络膜缺血。FAF 上最具特征的表现为双眼对称、融合的高低自发荧光斑点，早期局限于血管弓内，晚期可进展为中心萎缩并超出血管弓。开始用药时应完成眼底照相、FAF 和 OCT 基线检查，此后每年筛查；一旦出现视网膜病变，应与处方医生和患者讨论停药或减量。与羟氯喹相同，停药后病变不可逆，并可能继续进展。GLP-1 受体激动剂：AMD 方面未见风险增加，DR 方面证据尚不一致美国约每8名成人中有1人使用过胰高血糖素样肽-1受体激动剂（Glucagon-Like Peptide-1 Receptor Agonist，GLP-1 RA），约一半成人符合减重用药条件。多项回顾性队列研究显示，GLP-1 RA 可能与非新生血管性 AMD 风险降低相关，未见新生血管性 AMD 风险增加。与糖尿病视网膜病变的关系尚不明确，大型数据库研究结论不一，需要前瞻性研究验证。目前医学界的共识是，优先考虑这类药物在降低心脑血管风险方面的获益。所有糖尿病患者均应进行基线眼科检查和定期随访；血糖控制快速改善的患者可缩短随访间隔，已有 PDR 者可考虑在用药前先行治疗。图7 GLP-1 RA 与 AMD 关联的研究汇总抗肿瘤药物：识别特征性表现紫杉醇和多西他赛等紫杉烷类微管抑制剂可引起荧光素血管造影无渗漏的黄斑囊样水肿，停药后通常消退。MEK 抑制剂可引起视网膜下液积聚，与中心性浆液性脉络膜视网膜病变的区别在于：多为多灶性积液，脉络膜厚度正常，且不伴色素上皮脱离。免疫检查点抑制剂偶可引起葡萄膜炎和 Vogt-小柳-原田样综合征。 Kovach 教授总结，眼科医生需要了解可能引起新型视网膜毒性的药物及其筛查方案，详细询问用药史是前提；部分药物所致损害不可逆，需要生物标志物改善风险分层。在讨论环节，她补充：上述药物如有条件，均建议在用药前完成基线检查，使用 GLP-1 RA 的糖尿病患者尤其需要。小结本单元的内容几乎都能直接用于日常诊疗：给 AMD 高风险人群的生活方式与饮食建议、心脑血管事件后抗 VEGF 治疗的连续性、玻璃体切割术前注射时机，以及羟氯喹筛查方案的更新。其中关于 PDR 术前抗 VEGF 注射时机的研究来自中山眼科中心，是本单元唯一入选的中国团队研究。参考文献： 1. Seddon JM, De D, Rosner B. Quantifying Effects of Diet and Lifestyle Changes on Progression to Advanced Age Related Macular Degeneration in High Genetic Risk Individuals. Ophthalmology. 2026;133(3):333-349. doi:10.1016/j.ophtha.2025.09.030 2. Keenan TDL, Hébert M, Chew EY, Johnson MW. What Should Patients With Age-Related Macular Degeneration Eat? Am J Ophthalmol. 2026;288:12-21. doi:10.1016/j.ajo.2026.04.003 3. Bordbar DD, et al. Peri-Event Intravitreal Anti-VEGF and Systemic Outcomes After Stroke or Myocardial Infarction. JAMA Ophthalmol. 2026;144(5):415-422. doi:10.1001/jamaophthalmol.2026.0460 4. Bates B, et al. Endophthalmitis Incidence after Intravitreal Injection of Anti-VEGF Agents with Povidone-Iodine versus Aqueous Chlorhexidine Antisepsis. Ophthalmol Retina. 2025;9(10):928-933. doi:10.1016/j.oret.2025.03.022 5. Zhan J, et al. Timing of Preoperative Anti-VEGF for Vitrectomy in Proliferative Diabetic Retinopathy: A Competing-Risks Analysis of a Large Cohort. Ophthalmol Retina. 2026;10(5):532-542. doi:10.1016/j.oret.2025.12.019 6. Ni RL, et al. Efficacy of Prophylactic Laser Treatment of Lattice Degeneration in the Fellow Eyes of Patients with Retinal Breaks in the First Eye. Ophthalmol Retina. 2026. doi:10.1016/j.oret.2026.06.016 7. Ali AL, et al. Dropless Pars Plana Vitrectomy Using Intravitreal Decanted Triamcinolone and Moxifloxacin: Safety and Efficacy. Retina. 2026. doi:10.1097/IAE.0000000000004947 8. Marmor MF, et al. Special AAO Report: Recommendations on Screening for Hydroxychloroquine Retinopathy (2025 Revision). Ophthalmology. 2026;133(4):439-450. doi:10.1016/j.ophtha.2025.11.001 9. 待核实：Gaurav Shah 等关于眼内气体配比错误诉讼的 Ophthalmology Retina 短篇报告（标题、年份） END 更多会议信息&学术资讯，敬请关注：“医学进行时”微信公众号

2026-10-09

·BioSpace

Outlook Therapeutics Names Greg DiPasquale Chief Commercial Officer

Veteran retina commercial leader, who has helped launch BEOVU®, EYLEA® and EYLEA® HD, to lead U.S. commercialization of LYTENAVA™ (bevacizumab-vikg) ISELIN, N.J., Oct. 09, 2026 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company focused on the development and commercialization of LYTENAVA™ (bevacizumab-vikg, bevacizumab gamma) for the treatment of retinal diseases, today announced Greg DiPasquale as Chief Commercial Officer. Mr. DiPasquale, who joined Outlook in December 2025 as Head of Commercial for LYTENAVA™, will lead all commercial functions as the Company prepares to make LYTENAVA, the first and only FDA-approved ophthalmic formulation of bevacizumab for the treatment of wet age-related macular degeneration (wet AMD), available to eligible patients in the United States before the end of 2026. Mr. DiPasquale brings more than 30 years of commercial leadership experience, including nearly two decades in eye care and multiple product launches in retina. LYTENAVA will be the fifth retina launch of his career, following BEOVU ® (brolucizumab) at Novartis, the EYLEA ® prefilled syringe and EYLEA ® HD at Regeneron, and the TRIESENCE ® relaunch at Harrow. Most recently, he served as Senior Vice President and Head of Commercial at Harrow, where he led the commercial organization for the company's branded ophthalmic pharmaceutical portfolio. Before that, he was National Business Director for EYLEA at Regeneron, leading national sales for the product's largest indications and its national strategic accounts within a portfolio generating approximately $6 billion in annual revenue. At Novartis, he was Vice President and Head of Sales for the newly formed Retina Division, where he built the U.S. sales organization from the ground up and led the October 2019 launch of BEOVU. Earlier, he held senior commercial leadership roles at Bausch + Lomb, Carl Zeiss Vision and Essilor USA. “Greg has spent his career putting experienced teams in front of retina specialists at the moments that matter most, and he has already built the foundation of our commercial organization. As we move from approval to launch, his leadership and his relationships across the retina community will be central to bringing LYTENAVA to physicians and patients,” said Bob Jahr, Chief Executive Officer of Outlook Therapeutics. “Several years ago, while working with higher-priced branded agents, I saw the opportunity to bring an FDA-approved bevacizumab option to patients, providers and payers,” said Mr. DiPasquale. “I have been impressed by this team's grit and perseverance in bringing LYTENAVA to approval, and I wanted to be part of making an immediate impact. In my career, I've seen companies that watch it happen, let it happen, or make it happen. Outlook Therapeutics is going to make it happen.” Mr. DiPasquale's will lead the commercialization teams including market access, commercial operations, marketing, sales, and reimbursement. Mr. DiPasquale holds a Bachelor of Business Administration in Marketing and Human Resources from Ohio University and an Executive MBA from Kent State University. He has also served as Executive in Residence and faculty lecturer at the Ohio University College of Business, where he sits on the Executive Advisory Board. About LYTENAVA™ (bevacizumab-vikg, bevacizumab gamma) LYTENAVA™ is an ophthalmic formulation of bevacizumab produced in the United States for the treatment of wet AMD. In the United States, LYTENAVA (bevacizumab-vikg) is the only ophthalmic formulation approved by the FDA. LYTENAVA (bevacizumab gamma) is also the subject of a centralized Marketing Authorization granted by the European Commission in the EU and Marketing Authorization granted by the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK for the treatment of adults with wet AMD. In certain European Union Member States, LYTENAVA must receive pricing and reimbursement approval before it can be sold. Bevacizumab-vikg (bevacizumab gamma in the EU and UK) is a recombinant humanized IgG1 monoclonal antibody specific to human vascular endothelial growth factor (VEGF). Bevacizumab binds VEGF and prevents the interaction of VEGF to its receptors (Flt-1 and KDR) on the surface of endothelial cells. LYTENAVA binds to all isoforms of VEGF-A, thereby preventing interaction with receptors VEGFR-1 and VEGFR-2. By inhibiting VEGF-A, LYTENAVA suppresses endothelial cell proliferation, neovascularization, and vascular permeability. Inhibition of such activity targets a pathophysiologic process that contributes to vision loss. Important Safety Information and Indication LYTENAVA (bevacizumab-vikg) is a vascular endothelial growth factor (VEGF) inhibitor indicated for the treatment of patients with neovascular (wet) age-related macular degeneration (nAMD). Contraindications LYTENAVA is contraindicated in patients with ocular or periocular infections, in patients with active intraocular inflammation, and in patients with a known hypersensitivity to bevacizumab products or any of the ingredients in LYTENAVA. Hypersensitivity reactions may manifest as severe intraocular inflammation. Warnings and Precautions Intravitreal injections have been associated with endophthalmitis and retinal detachments. Proper aseptic injection technique must always be used when administering LYTENAVA. In addition, patients should be monitored following the injection to permit early treatment should an infection occur. Increases in intraocular pressure have been noted post-injection (up to 60 minutes) while being treated with LYTENAVA. Monitor intraocular pressure prior to and following intravitreal injection with LYTENAVA and manage appropriately. Although there was a low rate of arterial thromboembolic events (ATEs) observed in the LYTENAVA clinical trials, there is a potential risk of ATEs following intravitreal use of VEGF inhibitors. ATEs are defined as nonfatal stroke, nonfatal myocardial infarction, or vascular death (including deaths of unknown cause). Adverse Reactions The most common adverse reactions (≥1%) reported in patients receiving LYTENAVA were conjunctival hemorrhage (4%), eye pain (2%), and vitreous floaters (2%). These are not all the possible side effects of LYTENAVA. You are encouraged to report side effects of prescription drugs to the FDA. Visit or call 1-800-FDA-1088. You may also report side effects to Outlook Therapeutics at 1-833-999-OTLK (6855). Please see the full U.S. Prescribing Information for LYTENAVA here. About Outlook Therapeutics, Inc. Outlook Therapeutics is a biopharmaceutical company focused on the development and commercialization of LYTENAVA (bevacizumab-vikg (U.S.), bevacizumab gamma (E.U.)). LYTENAVA is the only ophthalmic formulation of bevacizumab to receive U.S. FDA approval and European Commission and MHRA Marketing Authorization for the treatment of wet AMD. Outlook Therapeutics commenced commercial launch of LYTENAVA (bevacizumab gamma) in Germany, Austria, and the UK as a treatment for wet AMD. Forward-Looking Statements This press release contains statements that may or are considered “forward-looking statements”. All statements other than statements of historical facts are “forward-looking statements,” including those relating to future events. In some cases, you can identify forward-looking statements by terminology such as “anticipate,” “believe,” “can,” “could,” “continue,” “expect,” “may,” “on track,” “plan,” “potential,” “target,” “will,” or “would”, the negative of terms like these or other comparable terminology, and other words or terms of similar meaning. These include, among others, express or implied discussions regarding the Company’s planned launch of LYTENAVA in the United States and other jurisdictions and the timing thereof; expectations concerning potential revenue generation from sales of LYTENAVA; expectations surrounding market adoption of LYTENAVA; expectations regarding the potential impact of LYTENAVA in the retina community; Outlook Therapeutics’ development or future revenue plans for LYTENAVA generally; and other statements that are not historical fact. Although Outlook Therapeutics believes that it has a reasonable basis for the forward-looking statements contained herein, they are based on current expectations about future events affecting Outlook Therapeutics and are subject to risks, uncertainties, and factors relating to its operations and business environment, all of which are difficult to predict and many of which are beyond its control. These risk factors include those risks associated with developing and commercializing pharmaceutical product candidates, risks in obtaining necessary regulatory approvals, the content and timing of decisions by regulatory bodies, as well as those risks detailed in Outlook Therapeutics’ filings with the Securities and Exchange Commission (the SEC), including the Current Report on Form 8-K filed with the SEC on August 12, 2026 and the Quarterly Report on Form 10-Q for the quarter ended June 30, 2026, and future reports Outlook Therapeutics files with the SEC, which include uncertainty of market conditions and future impacts related to macroeconomic factors, including as a result of the ongoing overseas conflicts, tariffs, and trade tensions, fluctuations in interest rates and inflation, and potential future bank failures on the global business environment. These risks may cause actual results to differ materially from those expressed or implied by forward-looking statements in this press release. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Outlook Therapeutics does not undertake any obligation to update, amend, or clarify these forward-looking statements, whether as a result of new information, future events, or otherwise, except as may be required under applicable securities law. Investor Inquiries: Jenene Thomas Chief Executive Officer JTC Team, LLC T: 908.824.0775 OTLK@jtcir.com

上市批准高管变更

100 项与布西珠单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D11083	布西珠单抗	S01LA06	DB14864

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
伴有糖尿病的增殖性视网膜病变	日本	Novartis Pharma AG	2025-11-20
脉络膜新生血管	日本	Novartis Pharma AG	2020-03-25
糖尿病性黄斑水肿	日本	Novartis Pharma AG	2020-03-25
黄斑变性	日本	Novartis Pharma AG	2020-03-25
年龄相关性黄斑变性	加拿大	Novartis Pharmaceuticals Canada, Inc.	2020-03-12
湿性年龄相关性黄斑变性	美国	Novartis Pharmaceuticals Corp.	2019-10-07

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
息肉状脉络膜血管病	临床3期	韩国	Novartis Pharmaceuticals Corp.	2023-02-06
肥厚型脉络膜新生血管病变	临床3期	-	Novartis AG	2023-01-01
缺血型视网膜中央静脉阻塞	临床3期	中国	诺华（中国）生物医学研究有限公司	2019-10-08
黄斑水肿	临床3期	美国	Novartis Pharmaceuticals Corp.	2019-07-02
黄斑水肿	临床3期	中国	Novartis Pharmaceuticals Corp.	2019-07-02
黄斑水肿	临床3期	日本	Novartis Pharmaceuticals Corp.	2019-07-02
黄斑水肿	临床3期	奥地利	Novartis Pharmaceuticals Corp.	2019-07-02
黄斑水肿	临床3期	加拿大	Novartis Pharmaceuticals Corp.	2019-07-02
黄斑水肿	临床3期	捷克	Novartis Pharmaceuticals Corp.	2019-07-02
黄斑水肿	临床3期	丹麦	Novartis Pharmaceuticals Corp.	2019-07-02

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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


ARVO2026	N/A	VEGF \| CFTR	439	Netarsudil	繭憲築憲夢製觸積憲醖(醖淵簾夢壓鹹鑰憲鑰製) = 繭構願衊獵鬱鏇窪衊餘壓鏇餘獵製製繭觸衊簾 (網繭鏇淵糧膚積鬱蓋簾 )	积极	2026-05-03
				Ranibizumab	繭憲築憲夢製觸積憲醖(醖淵簾夢壓鹹鑰憲鑰製) = 顧顧鹽鬱鬱壓衊網築網壓鏇餘獵製製繭觸衊簾 (網繭鏇淵糧膚積鬱蓋簾 )
APAO2026	N/A	息肉状脉络膜血管病二线	14	Brolucizumab	窪鬱夢遞積鏇網齋顧襯(淵願積憲憲夢製艱繭鹹) = 鏇鹹鹽製醖廠網窪遞夢醖淵淵鹹衊範願餘鬱構 (範廠艱積齋鏇壓糧淵壓, 87.4) 更多	积极	2026-02-18
NCT04774926 (IMAGINE, Pubmed \| Ophthalmol Ther)	临床4期	湿性年龄相关性黄斑变性一线	122	Brolucizumab 6 mg	醖餘觸襯淵齋積膚積簾(衊製壓遞鬱網鑰壓齋夢) = 繭壓遞願艱鹹觸窪蓋鬱築觸觸鑰廠鏇艱蓋築醖 (醖遞顧積膚繭繭淵鏇構 ) 更多	积极	2025-10-01
HAWK (EURETINA2025)	临床3期	湿性年龄相关性黄斑变性	1,817	Brolucizumab q8w	鏇願網鹹願繭衊顧淵齋(顧構蓋膚鏇製夢糧壓艱) = 選製顧築淵餘艱製觸蓋夢醖築願膚選鹽淵鹽糧 (鏇願膚餘廠鏇築膚夢構 ) 更多	不佳	2025-09-04
				Brolucizumab q12w	鏇願網鹹願繭衊顧淵齋(顧構蓋膚鏇製夢糧壓艱) = 窪顧範鏇積鹹艱遞獵壓夢醖築願膚選鹽淵鹽糧 (鏇願膚餘廠鏇築膚夢構 ) 更多
EURETINA2025	N/A	中心性浆液性脉络膜视网膜病变	42	Intravitreal Brolucizumab (as needed administration)	蓋製獵鏇鏇觸獵網糧鏇(衊獵鏇壓醖顧範鹽鑰鑰): P-Value = 0.003 更多	积极	2025-09-04
				Oral Multivitamins
EURETINA2025	N/A	湿性年龄相关性黄斑变性	22	Brolucizumab	觸製廠淵蓋繭膚網餘廠(鹹獵網鹹鏇遞餘餘廠觸) = 壓蓋鹽餘淵廠遞糧鑰糧壓壓範網齋醖遞壓製簾 (遞襯壓鏇簾壓構簾夢網 ) 更多	不佳	2025-09-04
				Aflibercept	範膚鹹蓋醖夢範壓簾製(顧淵築鹹範鏇鹽繭築餘) = 範艱鹽願艱餘遞窪獵衊製構夢壓選膚築膚衊壓 (製壓廠願鏇簾獵鹽鏇餘 ) 更多
PROUD (EURETINA2025)	临床3期	息肉状脉络膜血管病	80	Personalized brolucizumab regimen	壓窪簾鹽醖淵衊選鑰鑰(醖鹹齋願餘網願廠製膚) = 衊遞鹽醖醖淵淵鹽顧鹹遞壓築襯範顧願憲範鹹 (鹽觸醖鹹繭醖餘願餘觸 ) 更多	积极	2025-09-04
				Standard brolucizumab regimen	壓窪簾鹽醖淵衊選鑰鑰(醖鹹齋願餘網願廠製膚) = 夢築窪選蓋壓築網願衊遞壓築襯範顧願憲範鹹 (鹽觸醖鹹繭醖餘願餘觸 ) 更多
EURETINA2025	N/A	湿性年龄相关性黄斑变性	75	Brolucizumab	壓壓選廠構繭膚觸窪範(顧積淵窪窪壓鹽醖範淵) = 觸築鹽鑰構壓壓壓構鹽積餘繭壓積壓襯構獵鹽 (鑰鹹憲鬱壓窪壓獵艱糧 ) 更多	积极	2025-09-04
EURETINA2025	N/A	湿性年龄相关性黄斑变性	63	Brolucizumab	積餘壓衊遞簾蓋繭鹽製(觸衊構廠築窪齋糧鬱範) = Two eyes in the brolucizumab group developed mild intraocular inflammation and IVT was continued with another anti-VEGF agent. 淵簾窪選選窪觸鏇餘壓 (範遞願蓋艱襯鏇衊簾膚 ) 更多	积极	2025-09-04
				Faricimab
ARVO2025	N/A	湿性年龄相关性黄斑变性	8,372	Eylea 2mg (Aflibercept) (IOP+10 spike monitoring)	構鹹鬱鏇積築衊鏇憲蓋(壓鹽憲範願繭憲鹹製繭) = 夢鏇選鑰鏇網鏇範願憲鏇觸艱範夢顧衊願鏇餘 (觸糧壓廠糧網願鹹廠餘 ) 更多	不佳	2025-05-04
				Vabysmo (Faricimab) (IOP+10 spike monitoring)	構鹹鬱鏇積築衊鏇憲蓋(壓鹽憲範願繭憲鹹製繭) = 網襯艱窪蓋艱繭簾夢齋鏇觸艱範夢顧衊願鏇餘 (觸糧壓廠糧網願鹹廠餘 ) 更多