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Last update 12 Sep 2026

Aflibercept

Last update 12 Sep 2026

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

Fc fusion protein

Synonyms

Aflibercept (Genetical Recombination), Aflibercept (genetical recombination) (JAN), Aflibercept (USAN/INN)

+ [13]

Target

PGF x VEGF-A

Action

inhibitors

Mechanism

PGF inhibitors(Placental Growth Factor inhibitors), VEGF-A inhibitors(Vascular endothelial growth factor A inhibitors)

Therapeutic Areas

NeoplasmsCardiovascular DiseasesCongenital Disorders+ [7]

Active Indication

Retinopathy of PrematurityGlaucoma, NeovascularColorectal Cancer+ [15]

Inactive Indication

Advanced Colorectal AdenocarcinomaAdvanced Malignant Solid NeoplasmAngioid Streaks+ [35]

Originator Organization

Regeneron Pharmaceuticals, Inc.

Active Organization

Bayer AG

Regeneron Pharmaceuticals, Inc.

Bayer Yakuhin Ltd.

+ [8]

Inactive Organization

Sanofi

Santen Pharmaceutical Co., Ltd.

License Organization

Santen Pharmaceutical Co., Ltd.

Ocular Therapeutix, Inc.Bayer Korea Ltd.

+ [7]

Drug Highest PhaseApproved

First Approval Date

United States (18 Nov 2011),

Wet age-related macular degeneration

RegulationPriority Review (United States), Breakthrough Therapy (United States), Orphan Drug (United States), Priority Review (China)

Structure/Sequence

Sequence Code 4715606

Source: *****

542

Clinical Trials associated with Aflibercept

NCT07389980

/ RecruitingPhase 3IIT

Prospective Trial of the Efficacy and Safety of a Personalized Regimen of High-dose Aflibercept 8mg on Treatment-naive Polypoidal Choroidal Vasculopathy: the PALLAS Trial

The purpose of this study is to evaluate the efﬁcacy and safety of the aflibercept 8 mg used in a personalized regimen, with flexible loading dose and treatment intervals from 8 to 24 weeks in eyes with treatment-naive PCV.

Start Date24 Dec 2026

Sponsor / Collaborator

Yeungnam University College of Medicine

[+1]

NCT07761039

/ Not yet recruitingNot ApplicableIIT

Multicentre Observational Study to Investigate the Interval-Extension Potential, Effectiveness and Safety of Intravitreal Aflibercept 8 mg in Pretreated Eyes With Neovascular Age-Related Macular Degeneration (nAMD) or Diabetic Macular Oedema (DME) Under Routine Clinical Practice in Portugal

The goal of this multicentre observational study is to evaluate the interval-extension potential, effectiveness, and safety of intravitreal aflibercept 8 mg in pretreated eyes with neovascular age-related macular degeneration (nAMD) or diabetic macular oedema (DME) under routine clinical practice in Portugal.
It consists in an ambidirectional longitudinal cohort with retrospective collection of pre-switch clinical and treatment history and prospective follow-up after initiation of intravitreal aflibercept 8 mg in routine clinical practice.
The main questions it aims to answer are:
- Can treatment intervals be extended after switching to intravitreal aflibercept 8 mg while maintaining disease control in pretreated eyes with nAMD or DME? What are the functional, anatomical, and safety outcomes associated with intravitreal aflibercept 8 mg in routine clinical practice?
Participants are adults with nAMD or DME who have previously received intravitreal treatment and are switched to aflibercept 8 mg as part of routine clinical care. No study-specific interventions or procedures are performed. Clinical data are collected prospectively through the Portuguese national Retina.PT registry during routine follow-up visits, including treatment patterns, injection intervals, visual acuity, retinal anatomical assessments, and ocular and systemic safety outcomes.

Start Date01 Sep 2026

Sponsor / Collaborator-

ChiCTR2600128124

/ Not yet recruitingPhase 4IIT

Hyperreflective Foci as Early Biomarkers of Treatment Response to Intravitreal Aflibercept 8mg in Treatment-Naive Neovascular Age-Related Macular Degeneration (Heart Study)-A prospective, non-randomized, non-controlled, multi--center, study

Start Date31 Aug 2026

Sponsor / Collaborator

The Second Affiliated Hospital Zhejiang University

100 Clinical Results associated with Aflibercept

100 Translational Medicine associated with Aflibercept

100 Patents (Medical) associated with Aflibercept

3,727

Literatures (Medical) associated with Aflibercept

01 Feb 2027·TISSUE & CELL

Combined α-lactalbumin hydrolysate and anti-VEGF agent treatment attenuates ventilator-induced lung injury by suppressing the NLRP3 inflammasome pathway

Article

Author: Wang, Qi ; Ji, Yan ; Li, Yue ; Wan, ChaoQi ; Pan, JinJing

OBJECTIVE:

Ventilator-induced lung injury (VILI) poses a serious threat to patients receiving mechanical ventilation (MV). While studies suggest that α-lactalbumin hydrolysate (LAH) and anti-vascular endothelial growth factor (VEGF) agent can ameliorate inflammatory diseases, their efficacy in alleviating VILI remains poorly understood. This study aimed to investigate the preventive efficacy of LAH combined with Aflibercept (AFL, a VEGF trap) against VILI.

METHODS:

A mouse model of VILI was utilized to investigate the preventive potential of LAH and AFL on pulmonary damage and inflammatory responses. LAH (100 mg/kg) and AFL (10 mg/kg) were administered via gavage and intraperitoneal injection, respectively, prior to high tidal volume ventilation. Histopathological assessment of lung injury was performed through hematoxylin and eosin staining. To evaluate pulmonary vascular permeability, the lung wet-to-dry weight ratio was determined, and the total protein concentration in bronchoalveolar lavage fluid (BALF) was quantified. Apoptosis in lung tissues was analyzed via terminal deoxynucleotidyl transferase dUTP nick end labeling (TUNEL) assay. Neutrophil infiltration was assessed by measuring neutrophil counts and myeloperoxidase activity in BALF. The expression profiles of key molecular markers-including apoptosis-related proteins (Bax, Bcl-2), VEGF, constituents of the NOD-like receptor family pyrin domain‑containing 3 (NLRP3) inflammasome pathway, and inflammatory cytokines-were examined using quantitative real-time polymerase chain reaction, Western blot, enzyme-linked immunosorbent assay, and immunohistochemistry.

RESULTS:

LAH significantly attenuated lung pathological injury, apoptosis, and inflammation in VILI mice. Compared with normal controls, VEGF was pathologically upregulated in the lung tissues and BALF of VILI mice, and this elevation was reversed by LAH treatment. Further investigation revealed that AFL potentiated the inhibitory effects of LAH on lung injury and inflammation. Additionally, activation of the NLRP3/apoptosis-associated speck-like protein (ASC)/Caspase-1 inflammatory signaling pathway observed in VILI mice was significantly suppressed by the combined LAH and AFL treatment.

CONCLUSION:

Collectively, the combination of LAH and AFL ameliorates MV-induced lung injury and inflammation by suppressing the NLRP3 inflammasome signaling pathway. This study highlights a potential therapeutic target and proposes a novel strategy for the clinical prevention of VILI.

01 Feb 2027·BIOMATERIALS

A boronate-phenolic network nanoplatform carrying dimethyl itaconate for ameliorating neovascular age-related macular degeneration

Article

Author: He, Xianglin ; Xu, Mingyu ; Qie, Jiqiao ; Zhou, Yifan ; Zhang, Li ; Ye, Juan ; Xu, Yufeng ; Yu, Bo ; Jin, Qiao ; Han, Haijie

Age-related macular degeneration (AMD), particularly its neovascular form driven by choroidal neovascularization (CNV), remains leading cause of irreversible blindness worldwide. Current anti-vascular endothelial growth factor (VEGF) therapy offers limited efficacy, indicating that monotherapies targeting the downstream VEGF pathway cannot meet clinical needs, thus highlighting the demand for upstream and multifunctional therapeutic strategies. In this study, a boronate-phenolic network was constructed by cross-linking antioxidant tannic acid (TA) with ((1,3,5-Triazine-2,4,6-triyl)tris(benzene-4,1-diyl))triboronic acid (TBPT), in the presence of polyethylene glycol (PEG) for stabilization. Anti-inflammatory dimethyl itaconate (DMI) was further encapsulated, resulting in DTTP nanoparticles. With this multifunctional design, DTTP effectively promoted ROS elimination and mitochondrial protection, reestablished glutathione homeostasis, and downregulated genes involved in pyroptotic and inflammatory pathways. In a laser-induced CNV mouse model, intravitreal DTTP exhibited robust therapeutic efficacy with a favorable safety profile, achieving a 71.8% reduction in neovascularization and a 57.4% reduction in vascular leakage, with aflibercept serving as a clinically relevant benchmark. Collectively, DTTP represents a promising multifunctional nanotherapeutic for the management of neovascular AMD (nAMD).

01 Nov 2026·JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS

In-depth glycosylation and aspartic acid isomerization characterization of therapeutic fusion protein using electron transfer/higher-energy collision dissociation on the new hybrid high-resolution mass spectrometer

Article

Author: Yu, Chuanfei ; Xu, Gangling ; Wu, Gang ; Huang, Ziyi ; Du, Jialiang ; Zhang, Xiaoxi ; Guo, Luyun

Glycosylation is a critical post-translational modification (PTM) in biotherapeutics that influences protein structure, stability, pharmacokinetics, biological activity, and immunogenicity. Comprehensive characterization of glycosylation and other PTMs is therefore important for biopharmaceutical development and quality assessment. Aflibercept is a recombinant fusion protein containing five N-glycosylation sites and multiple potential O-glycosylation sites. Although site-specific N-glycosylation of aflibercept has been previously investigated, integrated characterization of glycosylation heterogeneity and aspartic acid (Asp) isomerization using an electron-transfer/higher-energy collision dissociation (EThcD) based workflow remains limited. In this study, EThcD data-dependent MS² (ddMS²) peptide mapping was performed on a Thermo Scientific Orbitrap Excedion Pro mass spectrometer equipped with the EASY-ETD option for detailed characterization of aflibercept. Site-specific N-glycosylation profiles at all five glycosylation sites were identified and relatively quantified. In addition, an O-glycopeptide localized at S12 was detected, providing direct experimental evidence supporting site-specific O-glycosylation in aflibercept. The EThcD fragmentation approach also enabled differentiation and localization of isoAsp residues through characteristic diagnostic fragment ions, including low-abundance peptides containing multiple Asp residues. Several additional PTMs, including deamidation and oxidation, were simultaneously characterized within the same analytical workflow. The results also indicate that EThcD peptide mapping can support the integrated multi-attribute method (MAM) concept for complex glycoproteins by combining glycosylation analysis, Asp/isoAsp differentiation, and PTM profiling in a single experiment. This workflow may be useful for detailed structural characterization and analytical comparability assessment of therapeutic glycoproteins and biosimilars.

978

News (Medical) associated with Aflibercept

09 Sep 2026

·www.businesswire.com

Ashvattha Therapeutics Announces Investor and Conference Presentations

REDWOOD CITY, Calif.--(BUSINESS WIRE)--Ashvattha Therapeutics ("Ashvattha"), a clinical-stage company developing an at-home subcutaneous (subQ) monthly treatment, announced presentations at HC Wainwright Conference, Ophthalmology Futures Retina Forum, and EURETINA, highlighting clinical trial results of migaldendranib (MGB) for the treatment of diabetic macular edema (DME) and neovascular age-related macular degeneration (nAMD). Globally, approximately half (50%) of DME and nAMD patients discontinue treatment after 2-3 years due to the burden of frequent clinic visits often requiring 3-6 hours due to travel and the visit. The majority of these patients have bilateral disease, requiring an intravitreal (IVT) injection in each eye and often separate office visits for each procedure. Even a long-acting product would still require these patients to have a minimum of 4 office visits per year (one visit per eye, twice per year). In contrast, MGB is subcutaneously injected at-home once per month treating both eyes (bilateral treatment effect). Transitioning these patients to a treatment paradigm that includes subQ MGB, could allow them to retain vision with fewer office visits while still under the expert care and guidance of their retina specialist. MGB Phase 2 Study Overview Ashvattha has completed its two-stage Phase 2 trial of migaldendranib (MGB), a hydroxyl dendrimer conjugated to a VEGFR tyrosine kinase inhibitor delivered subcutaneously. Phase 2 data will be presented at the upcoming EURETINA annual meeting in Vienna with a focus on results that continue to demonstrate intended biological activity in the retina after subQ administration and positive efficacy outcomes. Positive topline results from the chronic-dosing stage were previously reported; results from the single-ascending-dose mechanism-of-action stage will be presented at EU Retina. The Phase 2 clinical study enrolled DME and nAMD participants previously treated with anti-VEGF injections. In the first stage, participants received a single IVT aflibercept dose in the designated study eye (worse-seeing eye) and were observed until retinal fluid returned to baseline. They then received a single subQ dose of MGB in a dose-escalation design. Supplemental anti-VEGF IVT rescue could be administered according to pre-defined criteria. Results BCVA was generally stable in all participants through the primary endpoint at Week 12 Central subfield thickness (CST) remained stable for ≥4 weeks in participants receiving 1.0 or 2.0 mg/kg, with no required supplemental anti-VEGF IVT injections SubQ MGB was safe and well tolerated with no reported treatment-related systemic or ocular serious adverse events (SAEs); mild injection site reactions occurred in two participants A single systemic subQ dose of MGB demonstrated its localization and activity in the retina. Clinical outcomes support MGB's dual anti-VEGF and anti-inflammatory mechanism, normalizing VEGF, IL-6, and IL-1β in activated macrophages, microglia, and hypoxic RPE. A bilateral treatment effect was seen. Phase 2 data from both stages of the study, support advancement into Phase 2b in DME. "Ashvattha’s clinical trials to date have demonstrated MGB’s localization and activity in the eye, resulting in structural and functional benefits and a reduced need for intravitreal anti-VEGF," said Susan Schneider, MD, Acting Chief Medical Officer of Ashvattha Therapeutics. “In these clinical trials, MGB was safe and well tolerated, potentially allowing at-home subQ administration and a bilateral treatment effect. We are excited about our Phase 2b/3 study in DME patients, currently planned for 2027.” “We are focused in retaining patients who otherwise stop visiting their ophthalmologist. Diabetic patients are often working age and must take significant time off work to remain compliant with current therapies,” said George Montgomery, Chairman of Ashvattha Therapeutics. “Our global market research indicates approximately half of patients stop receiving treatment after 2-3 years, a market substantially larger than currently treated patients. By continuing to treat these discontinued patients, MGB will maintain their vision, and retain them in the clinical practice of retinal ophthalmologists. We look forward to initiating our Phase 2b/3 trial in DME patients agreed upon with FDA.” Presentations: Meeting: HC Wainwright Annual Conference, September 14-16, 2026 Presentation Time/Location: September 14, 2026, Virtual Presenter: Jeffrey L Cleland, PhD Meeting: Ophthalmology Futures Retina Forum, September 30, 2026 Presentation Time/Location: Imperial Riding School, Vienna Presenter: Susan Schneider, MD Title: Ashvattha Therapeutics, Inc. presentation and Retina Forum panel Meeting: EURETINA, October 1-4, 2026 Session: e-Poster Presenter: Prof. Paulo Eduardo Stanga, The Retina Clinic London Ophthalmic Institute Abstract Number: RETINA26-1222 Abstract Title: Migaldendranib, a novel first-in-class hydroxyl dendrimer nanomedicine administered subcutaneously for the treatment of diabetic macular edema and neovascular age-related macular degeneration About Migaldendranib Migaldendranib (MGB) is a novel first-in-class nanomedicine in clinical development for the treatment of DME and nAMD. Administered subcutaneously, MGB has a differentiated mechanism of action that crosses the blood-retinal barrier in regions of inflammation and selectively normalizes VEGF expression in activated macrophages and microglia, and hypoxic retinal pigment epithelial cells in the retina. MGB also normalizes IL-6 and IL-1β expression in activated macrophages. Phase 2 clinical trial results demonstrate that subcutaneous MGB is safe and well-tolerated across multiple doses, with the potential for convenient once-monthly at-home administration that could significantly reduce intravitreal injection burden for patients with DME and nAMD, including those with bilateral disease. About Ashvattha Therapeutics Ashvattha Therapeutics is advancing a new class of clinical-stage nanomedicine therapeutics that traverse tissue barriers to selectively target and reprogram activated cells only in regions of inflammation. Our targeted nanomedicine approach seeks to redefine precision medicine, empowering a new standard of care in ophthalmology. Ashvattha Therapeutics was founded by Kannan Rangaramanujam, Sujatha Kannan, and Jeff Cleland and incubated by Natural Capital. For more information, visit: www.avttx.com

Clinical ResultPhase 2

02 Sep 2026

·www.biospace.com

EyePoint Announces Participation at Upcoming Investor Conferences and Scientific Meeting

WATERTOWN, Mass., Sept. 02, 2026 (GLOBE NEWSWIRE) -- EyePoint, Inc. (Nasdaq: EYPT), a company committed to developing and commercializing innovative therapeutics to improve the lives of patients with serious retinal diseases, today announced that the Company will participate at the following upcoming conferences: Citi 2026 Biopharma Back to School Conference Forum: Fireside Chat Date: September 9, 2026 Time: 8:00 am ET Cantor Global Healthcare Conference 2026 Forum: Fireside Chat Date: September 10, 2026 Time: 10:20 am ET Morgan Stanley Global Healthcare Conference Forum: Fireside Chat Date: September 15, 2026 Time: 7:00 am ET A webcast and subsequent archived replay of each fireside chat at the Investor Conferences may be accessed via the Investors section of the Company website at . Scientific Meeting EyePoint will be participating at The Retina Society 59th Annual Scientific Meeting from September 23-26, 2026, in Los Angeles, CA. Presentation: Bioerodible EYP-1901 (Vorolanib Intravitreal Insert) for Sustained Release of a Tyrosine Kinase Inhibitor for Retinal Exudative Disease: Mechanism of Action and Pharmacokinetic Characteristics Presenter: Ehsan Rahimy, M.D. Date & Time (Session): September 24, 2026 | 11:15 AM PT (AMD I) Presentation: LUGANO Phase 3 Trial of Bioerodible EYP-1901 (Vorolanib Intravitreal Insert) vs Aflibercept in Patients with Neovascular Age-Related Macular Degeneration (nAMD): First-Time Vision and Anatomic Outcomes Presenter: Carl D. Regillo, M.D., FACS, FASRS Date & Time (Session): September 24, 2026 | 11:18 AM PT (AMD I) Presentation: LUGANO Phase 3 Trial of Bioerodible EYP-1901 (vorolanib intravitreal insert) vs Aflibercept in Patients with Neovascular Age-Related Macular Degeneration (nAMD): First-Time Safety and Treatment Burden Outcomes Presenter: Charles C. Wykoff, M.D., Ph.D. Date & Time (Session): September 24, 2026 | 11:23 AM PT (AMD I) Presentation: Association Between Central Subfield Thickness (CST) Fluctuation and Visual Acuity (VA) Outcomes in Patients with Neovascular Age-Related Macular Degeneration (nAMD): An IRIS ® Registry Analysis Presenter: Durga S. Borkar, MD, MMCi Date & Time (Session): September 25, 2026 | 3:45 PM PT (AMD III) Presentations from The Retina Society will be available in the Scientific Publications section of the Company website at . About EyePoint ezstandalone.cmd.push(function () { ezstandalone.showAds(131); }); EyePoint, Inc. (Nasdaq: EYPT) is a clinical-stage biopharmaceutical company committed to developing and commercializing innovative therapeutics to improve the lives of patients with serious retinal diseases. The Company’s lead product candidate, DURAVYU™, is an innovative investigational sustained delivery treatment for serious retinal diseases combining vorolanib, a selective and patent-protected tyrosine kinase inhibitor, in next-generation bioerodible Durasert E™ technology. Supported by robust safety and efficacy data across multiple clinical trials and indications, DURAVYU is currently being evaluated in Phase 3 pivotal trials for wet age-related macular degeneration (wet AMD) and diabetic macular edema (DME). The Company is committed to partnering with the retinal community to improve patient lives while creating long-term value, with four approved drugs over three decades and tens of thousands of eyes treated with EyePoint innovation. EyePoint is headquartered in Watertown, Massachusetts, with a commercial manufacturing facility in Northbridge, Massachusetts. Vorolanib is licensed to EyePoint exclusively by Equinox Sciences, a Betta Pharmaceuticals affiliate, for the localized treatment of all ophthalmic diseases outside of China, Macao, Hong Kong and Taiwan. ezstandalone.cmd.push(function () { ezstandalone.showAds(132); }); DURAVYU ™ has been conditionally accepted by the FDA as the proprietary name for EYP-1901. DURAVYU is an investigational product; it has not been approved by the FDA. FDA approval and the timeline for potential approval is uncertain. Investors: Robin Garner EyePoint, Inc. ir@eyepoint.bio Media: Helen O’Gorman FTI Consulting media@eyepoint.bio

Phase 3Drug Approval

31 Aug 2026

·www.globenewswire.com

Alvotech Announces FDA Acceptance for Review of Biologics License Application for AVT80, Expanding Proposed Biosimilar Program for Entyvio® to Subcutaneous Presentations

REYKJAVIK, Iceland, Aug. 31, 2026 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO; ALVO-SDB), a global biotechnology company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) for AVT80, a proposed interchangeable biosimilar to Entyvio® (vedolizumab) prefilled syringe and autoinjector for subcutaneous administration. Under a partnership with Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), Alvotech is responsible for the development and manufacturing of AVT80, while Teva is responsible for commercialization. “FDA’s acceptance for review of our BLA for AVT80 is another important milestone for our vedolizumab biosimilar program,” said Joseph McClellan, Chief Operating Officer of Alvotech. “Together with our BLA for AVT16, which was accepted for review in May, the program encompasses both intravenous and subcutaneous presentations, including a prefilled syringe and autoinjector.” Entyvio is a biologic medicine approved for the treatment of adults with moderately to severely active ulcerative colitis and Crohn’s disease. The BLA submission is supported by a comprehensive data package, including analytical, pharmacokinetic, and immunogenicity data generated to support the demonstration of biosimilarity between AVT80 and the reference product. AVT80 has been submitted as a proposed interchangeable biosimilar. In the United States, an interchangeable biosimilar may be substituted for the reference product at the pharmacy without the intervention of the prescriber, subject to applicable laws. If approved, AVT80 would add to the range of biosimilar options available to patients and healthcare providers in the United States. In February 2026, Alvotech announced positive results from a pivotal pharmacokinetic study for AVT80. The randomized, double-blind, single-dose, parallel-group, three-arm study compared AVT80 to Entyvio in healthy adult participants and met all its primary endpoints. Based on regulatory advice, the clinical study is considered pivotal to support the demonstration of clinical similarity for both AVT16 and AVT80. About AVT80 and AVT16 AVT80 is a proposed interchangeable biosimilar candidate to Entyvio (vedolizumab), a humanized monoclonal antibody. It is being developed as a prefilled syringe and autoinjector for subcutaneous administration. AVT80 complements AVT16, Alvotech’s proposed interchangeable biosimilar to Entyvio for intravenous administration for which the FDA accepted a BLA for review in May 2026. In the European Union, the European Medicines Agency has validated a Marketing Authorization Application covering both AVT16 (lyophilized vial) and AVT80 (pre-filled syringe and autoinjector). Together these two candidates form part of Alvotech’s broader pipeline of biosimilar candidates in immunology aimed at expanding access to biologic medicines in major therapeutic areas. AVT16 and AVT80 are investigational products and have not received regulatory approval in any markets. Biosimilarity and interchangeability have not been established by regulatory authorities and are not claimed. About Entyvio Entyvio (vedolizumab) is an integrin receptor antagonist indicated for the treatment of adults with moderately to severely active ulcerative colitis and Crohn’s disease. Vedolizumab targets and binds specifically to the alpha-4-beta-7 integrin, which is involved in the migration of certain white blood cells into gastrointestinal tissue. Use of trademarks Entyvio is a registered trademark of Millennium Pharmaceuticals, Inc. The use of this trademark is solely for the purpose of identifying the reference product. Alvotech and Teva do not claim any rights to the trademark. For further information, contact: MediaBenedikt StefanssonSarah MacLeodalvotech.media@alvotech.com InvestorsDr. Balaji V PrasadBenedikt StefanssonMikaela Vilchezalvotech.ir@alvotech.com About Alvotech Alvotech is a biotechnology company, founded by Robert Wessman, focused solely on the development and manufacture of biosimilar medicines for patients worldwide. Alvotech seeks to be a global leader in the biosimilar space by delivering high-quality, cost-effective products and services, enabled by a fully integrated approach and broad in-house capabilities. Five biosimilars are already approved and marketed in multiple global markets, including biosimilars to Humira® (adalimumab), Stelara® (ustekinumab), Simponi® (golimumab), Eylea® (aflibercept) and Prolia®/Xgeva® (denosumab). The current development pipeline includes disclosed biosimilar candidates aimed at treating autoimmune disorders, eye disorders, and cancer. Alvotech has formed a network of strategic commercial partnerships to provide global reach and leverage local expertise in markets that include the United States, Europe, Japan, China, and other Asian countries and large parts of South America, Africa and the Middle East. For more information, please visit https://www.alvotech.com. None of the information on the Alvotech website shall be deemed part of this press release. For more information, please visit our website or follow us on social media on LinkedIn, Facebook, Instagram, and YouTube. Forward Looking Statements Certain statements in this communication may be considered “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements include, for example, Alvotech’s expectations regarding competitive advantages, business prospects and opportunities including pipeline product development, future plans and intentions, regulatory submissions, review and interactions, the potential approval and commercial launch of its product candidates, the timing of regulatory approval, market launches and financial projections. Such forward-looking statements are subject to risks, uncertainties, and other factors which could cause actual results to differ materially from those expressed or implied by such forward-looking statements. These forward-looking statements are based upon estimates and assumptions that, while considered reasonable by Alvotech and its management, are inherently uncertain and are inherently subject to risks, variability, and contingencies, many of which are beyond Alvotech’s control. Factors that may cause actual results to differ materially from current expectations include, but are not limited to factors set forth in the sections entitled “Risk Factors” and “Cautionary Note Regarding Forward-Looking Statements” in documents that Alvotech may from time-to-time file or furnish with the SEC. There may be additional risks that Alvotech does not presently know or that Alvotech currently believes are immaterial that could also cause actual results to differ from those contained in the forward-looking statements. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as, and must not be relied on by an investor as, a guarantee, assurance, prediction or definitive statement of a fact or probability. Alvotech does not undertake any duty to update these forward-looking statements or to inform the recipient of any matters of which any of them becomes aware of which may affect any matter referred to in this communication. Alvotech disclaims any and all liability for any loss or damage (whether foreseeable or not) suffered or incurred by any person or entity as a result of anything contained or omitted from this communication and such liability is expressly disclaimed.

Clinical ResultDrug Approval

100 Deals associated with Aflibercept

External Link

KEGG	Wiki	ATC	Drug Bank
D09574	Aflibercept	L01XX44 S01LA05	DB08885

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Retinopathy of Prematurity	Japan	Bayer Yakuhin Ltd.	26 Sep 2022
Glaucoma, Neovascular	Japan	Bayer Yakuhin Ltd.	25 Mar 2020
Colorectal Cancer	Japan	Sanofi KK	30 Mar 2017
Diabetic Retinopathy	United States	Regeneron Pharmaceuticals, Inc.	25 Mar 2015
Macular Edema	Japan	Bayer Yakuhin Ltd.	22 Nov 2013
Blindness	South Korea	Bayer Korea Ltd.	20 Mar 2013
Retinal Vein Occlusion	European Union	Bayer AG	21 Nov 2012
Retinal Vein Occlusion	Iceland	Bayer AG	21 Nov 2012
Retinal Vein Occlusion	Liechtenstein	Bayer AG	21 Nov 2012
Retinal Vein Occlusion	Norway	Bayer AG	21 Nov 2012
Retinal Vein Occlusion	United Kingdom	Bayer Plc	21 Nov 2012
Choroidal Neovascularization	Japan	Bayer Yakuhin Ltd.	28 Sep 2012
Macular Degeneration, Age-Related, 1	Japan	Bayer Yakuhin Ltd.	28 Sep 2012
Metastatic Colorectal Carcinoma	United States	Sanofi-Aventis U.S. LLC	03 Aug 2012
Diabetic macular oedema	Australia	Bayer Australia Ltd.	07 Mar 2012
Myopic choroidal neovascularization	Australia	Bayer Australia Ltd.	07 Mar 2012
Retinal vein occlusion-related macular edema	Australia	Bayer Australia Ltd.	07 Mar 2012
Wet age-related macular degeneration	United States	Regeneron Pharmaceuticals, Inc.	18 Nov 2011

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Polypoidal choroidal vasculopathy	Phase 3	South Korea	Bayer AG	24 Dec 2026
Edema	Phase 3	United States	Bayer AG	15 May 2023
Edema	Phase 3	China	Bayer AG	15 May 2023
Edema	Phase 3	Japan	Bayer AG	15 May 2023
Edema	Phase 3	Australia	Bayer AG	15 May 2023
Edema	Phase 3	Austria	Bayer AG	15 May 2023
Edema	Phase 3	Bulgaria	Bayer AG	15 May 2023
Edema	Phase 3	Czechia	Bayer AG	15 May 2023
Edema	Phase 3	Estonia	Bayer AG	15 May 2023
Edema	Phase 3	France	Bayer AG	15 May 2023

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03984110 (COED, Pubmed \| Retina)	Phase 3	Diabetic macular oedema	50	Dexamethasone implant + intravitreal aflibercept	bvmocofpea(fyisbvzvwm) = Three eyes and two eyes in the combined therapy group developed worsening cataracts and IOP elevation requiring medical management, respectively. rcinqijvdq (esbrvlxfko ) View more	Similar	01 Sep 2026
				Intravitreal aflibercept
NCT04411693 (PRECISION, CTgov)	Phase 4	Diabetic macular oedema	23	Dexamethasone implant+aflibercept (Group A: Intravitreal Dexamethasone Implant)	cxsdiupolr(bvrebhlgnu) = ipvqmdgrso wzaufrnjpy (thvrvryegm, 6.6) View more	-	29 Jul 2026
				Aflibercept (Group B: Intravitreal Aflibercept)	cxsdiupolr(bvrebhlgnu) = duftrzltiv wzaufrnjpy (thvrvryegm, 7.2) View more
NCT04423718 \| NCT04429503 (PHOTON, Pubmed \| Ophthalmol Ther)	Phase 3	Diabetic macular oedema \| Wet age-related macular degeneration	1,667	Aflibercept 8 mg	ojzpliuqgf(yztzdztkzn) = ykhjnclvqw xytidkqrsf (gqtytbtvuy ) View more	Positive	01 Jul 2026
				Aflibercept 2 mg	ojzpliuqgf(yztzdztkzn) = sahtsyexdt xytidkqrsf (gqtytbtvuy ) View more
NCT04423718 (PULSAR, Pubmed \| Int J Retina Vitreous)	Phase 3	Wet age-related macular degeneration	101	aflibercept 8 mg every 12 weeks	oraomabnhf(crneigvcle) = xoorbmdhsg uutlisgbao (ospeetaske, 9.0 - 17.4) View more	Positive	26 Jun 2026
				aflibercept 8 mg every 16 weeks	oraomabnhf(crneigvcle) = msegthwumu uutlisgbao (ospeetaske, 5.8 - 13.7) View more
NCT04810585 (KCSG CO21-21, ASCO2026)	Phase 2	Advanced Colorectal Adenocarcinoma Second line PlGF \| IL-8 \| TIMP-1 ... View more	159	Aflibercept plus FOLFIRI	ywzhoszxyo(ibbusdfksf) = oyphlimpva lerhodqpvo (igjmbjndsx ) View more	Positive	29 May 2026
NCT05989126 (CTgov)	Phase 3	Diabetic macular oedema \| Wet age-related macular degeneration	35	Aflibercept	zhgswoxszq = eoxjdapetq hbmenuubxk (ezxncusbaw, hxjnrnqdyh - kdukwtmhjy) View more	-	28 May 2026
NCT07390253 (Pubmed \| Ophthalmol Ther)	Not Applicable	Wet age-related macular degeneration	50	Aflibercept 8 mg (nAMD)	tyrirwtfil(dxfdacstwx) = dyltpxevbh ssmwwqrdnl (hbeybafdpd )	Positive	19 May 2026
NCT06075147 (SPECTRUM, ARVO2026)	Not Applicable	-	190	aflibercept 8 mg (UK TN nAMD cohort)	pldomrpicr(vohytihjdi) = ziuqpdcedw qwhixafccx (jpxpzmfunm, 3.4 - 9.0) View more	Positive	03 May 2026
				aflibercept 8 mg (UK PT nAMD cohort)	pldomrpicr(vohytihjdi) = accmocsjgx qwhixafccx (jpxpzmfunm, 0.0 - 4.2) View more
ARVO2026	Not Applicable	Age Related Macular Degeneration	1,766	Aflibercept 2mg	rzqvmtbhly(vtzxqpwyly): RR = 0.63 (95.0% CI, 0.37 - 1.05), P-Value = 0.08 View more	Positive	03 May 2026
				Aflibercept 8mg
ARVO2026	Not Applicable	Wet age-related macular degeneration	67	Aflibercept 8 mg	nkgscgvhvw(abcoznshrr) = pmwndoauos desvdgoovn (cglzpjicuv ) View more	Positive	03 May 2026
				Faricimab	nkgscgvhvw(abcoznshrr) = eupipgxuyw desvdgoovn (cglzpjicuv ) View more

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