A Multi Center, Extension Study to Evaluate the Safety and Efficacy of MYL-1701P in Subjects With Diabetic Macular Edema Completed MYL-1701P-3001 Study.

This Study (AFIL-IJZ-3002) is designed to evaluate the safety, efficacy and immunogenicity of MYL-1701P among a group of participants successfully completing MYL-1701P-3001 study.

Start Date23 Nov 2020

Sponsor / Collaborator

Mylan Pharmaceuticals, Inc.

[+1]

CTRI/2020/11/028961

/ CompletedPhase 3

A Multi center, Extension Study to Evaluate the Safety and Efficacy of MYL-1701P in Subjects with Diabetic Macular Edema Completed MYL-1701P-3001 Study.

Start Date03 Nov 2020

Sponsor / Collaborator

Mylan, Inc.

[+1]

NCT03610646

/ CompletedPhase 3

A Multi Center, Randomized, Double-Masked, Active-Controlled, Comparative Clinical Study to Evaluate the Efficacy and Safety of MYL-1701P and Eylea® in Subjects With Diabetic Macular Edema (DME)

Three hundred and twenty-four (324) eligible adult subjects with diabetes mellitus with central DME involvement to be randomized 1:1 to intravitreal treatment with MYL-1701P or Eylea®.
The primary endpoint is mean change from baseline in Best Corrected Visual Acuity (BCVA) as assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) letters. Pharmacokinetics (PK) and immunogenicity to be evaluated in the subjects participating in the study.

Start Date23 Aug 2018

Sponsor / Collaborator

Mylan Pharmaceuticals, Inc.

[+1]

100 Clinical Results associated with AFLIBERCEPT-JBVF

100 Translational Medicine associated with AFLIBERCEPT-JBVF

100 Patents (Medical) associated with AFLIBERCEPT-JBVF

Literatures (Medical) associated with AFLIBERCEPT-JBVF

01 Oct 2024·JAMA Ophthalmology

Aflibercept Biosimilar MYL-1701P vs Reference Aflibercept in Diabetic Macular Edema

Article

Importance:

Biosimilars may be lower-cost alternatives to originator biologic products, potentially offering expanded access or reduced economic burden, but have not been evaluated with aflibercept in diabetic macular edema (DME).

Objective:

To compare efficacy and safety of MYL-1701P, an aflibercept biosimilar, with reference aflibercept (Eylea [Regeneron]) in DME.

Design, Setting, and Participants:

This was a double-masked, randomized clinical trial that included participants at 77 centers across the US, Europe, Japan, and India. Included in the analysis were individuals 18 years and older with type 1 or type 2 diabetes with central DME and best-corrected visual acuity (BCVA) letter score of 73 to 38 in the study eye using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart. Study data were analyzed from October to December 2021.

Interventions:

Formulations of MYL-1701P (0.5-mg vial) or reference aflibercept every 4 weeks for 5 consecutive intravitreal injections, followed by every 8 weeks through week 52.

Main Outcomes and Measures:

The primary outcome was the adjusted difference in least squares mean (SE) change from baseline BCVA letter score at week 8 with an equivalence margin of −3 to +3 letters. Secondary outcomes included change in central subfield thickness (CST), BCVA, number of injections over 52 weeks, incidence of adverse events (AEs), and antidrug antibodies (ADAs).

Results:

A total of 355 participants (mean [SD] age, 62.2 [9.2] years; 216 male [60.8%]) were randomized to MYL-1701P (179 participants [50.4%]) and aflibercept (176 participants [49.6%]). At week 8, mean (SE) change in BCVA was 6.60 (0.55) letters vs 6.56 (0.55) letters in the MYL-1701P vs aflibercept groups. The adjusted mean difference of 0.04 letters (90% CI, −1.16 to 1.24 letters) met the primary outcome. At week 8, mean (SE) change in CST was −112 (7) μm vs −124 (7) μm in the MYL-1701P vs aflibercept groups (adjusted mean difference, 12 μm; 90% CI, −3 to 26 μm). The incidence of treatment-emergent AEs in the MYL-1701P and aflibercept arms were ocular (30.9% [55 of 178] vs 29.5% [52 of 176]), serious ocular (0.6% [1 of 178] vs 1.1% [2 of 176]), nonocular (65.2% [116 of 178] vs 65.3% [115 of 176]), and serious nonocular (16.9% [30 of 178] vs 11.9% [21 of 176]). The mean (SD) total number of injections was 8.4 (2.1) vs 8.7 (1.8) in the MYL-1701P vs aflibercept groups. The incidence of treatment-induced or treatment-boosted ADAs was 2.8% (5 of 177) vs 5.7% (10 of 176) in the MYL-1701P vs aflibercept arms.

Conclusions and Relevance:

MYL-1701P demonstrated clinical equivalence in regard to efficacy, with comparable safety and immunogenicity, to reference aflibercept. These findings support use of MLY-1701P as an alternative to reference aflibercept.

Trial Registration:

ClinicalTrials.gov Identifier: NCT03610646

01 Feb 1989·Scandinavian journal of immunologyQ4 · MEDICINE

Reduced Erythrocyte CR1 (CD 35) Receptor Function and Complement Opsonization in Factor I‐Deficient Patients is Restored by Plasma Infusion

Q4 · MEDICINE

Article

Author: H H Jepsen ; J M Rasmussen ; B Teisner ; S E Svehag

Erythrocytes (E) from three factor I‐deficient patients were investigated for surface‐bound complement factors and CR1 (CD 35) expression and function. The E were coated with C4b,C3b, and factor H. Following plasma infusion of in vitro incubation of the patients’ E with normal human serum (NHS) or purified factor I, cell‐bound C4b and C3b could no longer be detected. The E now expressed C3d, and factor H was unaffected, indicating that factor H was hound to the C3d part of the C3b molecules, providing the co‐factor for effective cleavage of E‐bound C3b when purified factor 1 was added. The binding of monoclonal anti‐CR1 antibodies (M710) to the patients’ E was markedly reduced compared with control E, and was not normalized by treatment with NHS, probably because covalently bound C3d/factor H interfered with the binding of M710. By contrast, the reduced ability of the patients’ E‐CR1 to bind complement‐opsonized immune complexes (IC) was normalized after plasma infusion. This shows that the impaired CR1 function was acquired and emphasizes the importance of performing functional CR1 assays. Complement opsonization of IC for binding to normal E was severely compromised in the patients’ sera due to consumption of factor B and C3. After plasma infusion the opsonization capacity of the patients’ sera was restored. Thus, two mechanisms of importance for normal clearance of IC were compromised in factor I‐deficient patients: (1) the opsonization of IC for binding to E‐CRI, and (2) the capacity of E‐CRI to bind opsonized complexes. Both dysfunctions were temporarily corrected by plasma infusion.

01 Jan 1986·Journal of immunopharmacology

Complement Receptors (CR) and Cytotoxic Responses: Monoclonal Antibodies Directed Against CR1 AMD CR3 Inhibit the Generation of Human Allospecific and Virus Specific Cytotoxic Cells in Vitro

Article

Author: Giorgio Inghirami ; George C. Tsokos ; John D. Lambris

A variety of cellular immune responses involve complement factors which bind to specific receptors, and modulate or effect a specific reaction. Monoclonal antibodies (MAb) have been generated against complement receptors (CR) 1 and 3, which were utilized to investigate human allogeneic and Epstein-Barr virus specific cytotoxic cells in vitro. MAb OKM1, which binds to the C3bi CR (CR3), and MAb M710, which binds to the C3b/4b CR (CR1), inhibited the generation of both allogeneic and virus specific cytotoxic responses in vitro in a dose-dependent way; doses of 1 microgram/ml (or greater) completely abrogated the cytotoxic responses. Inhibition of these responses was observed when the MAb was added to the cultures at any time point except the last two days. In addition, treatment of the responder (but not the stimulator cells) with either MAb resulted in complete inhibition of cytotoxic responses. These experiment indicate that complement receptors participate in the generation of human cytotoxic responses in vitro.

News (Medical) associated with AFLIBERCEPT-JBVF

27 Jun 2025

·pharma.economictimes.indiatimes.com

Biocon Biologics Receives Health Canada Approval for Yesafili

Bengaluru: Biocon Biologics Ltd. (BBL), a subsidiary of Biocon Ltd. has announced that Health Canada has granted a Notice of Compliance (NOC) for Yesafili (aflibercept) on 26 June 2025. The product, a biosimilar to Eylea (aflibercept), will be available in both vial and prefilled syringe formats (2 mg/0.05 mL) and is expected to launch in Canada on 4 July 2025. Yesafili is the first biosimilar to Eylea approved by Health Canada, expanding treatment options for patients with retinal vascular diseases. Approved indications for Yesafili include: Neovascular (wet) age-related macular degeneration (AMD) Visual impairment due to macular edema secondary to central retinal vein occlusion (CRVO) Visual impairment due to macular edema secondary to branch retinal vein occlusion (BRVO) Diabetic macular edema (DME) Myopic choroidal neovascularization (myopic CNV) The approval follows a review of a comprehensive data package, including analytical, nonclinical, and clinical studies. Health Canada concluded that Yesafili is highly similar to Eylea with no clinically meaningful differences in terms of quality, safety, and efficacy. By Online Bureau ,

Drug Approval

19 Jun 2025

·www.einpresswire.com

Seeing Beyond Sight: New Frontiers in AMD Treatment-Gene Therapy and Biosimilars Take Center Stage | CI Intelligence

Pioneering AMD therapies-gene therapy, biosimilars, long‑acting biologics-promise durable vision gains and reduced injection burden for aging populations. AMD treatment is entering a transformative era, where precision gene therapy and extended-duration biologics are redefining care. The market is poised to benefit both patients and healthcare systems.” — DataM Intelligence AUSTIN, TX, UNITED STATES, June 19, 2025 / EINPresswire.com / -- Revolutionizing AMD Care: From Monthly Injections to One-Time Gene Therapies In a watershed moment for retinal health, the Age-Related Macular Degeneration (AMD) therapeutics market is poised for transformation. A new wave of innovative treatments—from gene therapy to long-acting anti-VEGF biologics and biosimilars—is reshaping care protocols and expanding access for millions worldwide. With the global burden of AMD projected to surpass 300 million by 2040, the urgency to reduce injection frequency, slow disease progression, and improve affordability has never been more critical. Download CI Sample Report: https://www.datamintelligence.com/strategic-insights/ci/age-related-macular-degeneration-amd 🌍 Market Snapshot: AMD Therapeutics Poised for Growth - The global AMD therapeutics market was valued at approximately $14.24 billion in 2024, with expectations to reach $24.22 billion by 2033, registering a 6–8% CAGR over the forecast period. - North America remains the leading market due to high disease prevalence and early access to biologics, while Asia-Pacific is emerging rapidly with aging populations and increasing healthcare access. - Biosimilar competition, reimbursement reforms, and gene therapy innovations are key drivers shaping this growth trajectory. 🧬 Disease Overview: AMD at a Glance Age-related macular degeneration affects the macula—the central portion of the retina responsible for sharp, straight-ahead vision. It is the leading cause of irreversible vision loss in people aged 50 and older. Two Forms of AMD: - Dry AMD (Atrophic): The most common form, accounting for about 80% of cases. Characterized by thinning of the macula and drusen deposits. - Wet AMD (Neovascular): Less common but more severe. Marked by abnormal blood vessel growth beneath the retina, leading to leakage, scarring, and rapid vision loss. 💊 Current Therapies: Anti-VEGF Dominates, But GA Drugs Rising Wet AMD: Approved Therapies - Eylea (Aflibercept): VEGF and PlGF inhibitor, long-standing market leader. - Lucentis (Ranibizumab): Anti-VEGF monoclonal antibody fragment, widely adopted globally. - Beovu (Brolucizumab): Longer dosing intervals, though safety remains under scrutiny. - Vabysmo (Faricimab): Dual inhibition of VEGF-A and Ang-2; allows for 16-week dosing intervals. - Off-label Avastin (Bevacizumab): Economical alternative, frequently used off-label. Recent Developments: Biosimilars: Byooviz (ranibizumab-nuna), Yesafili, and Opuviz (aflibercept biosimilars) are now FDA-approved, offering cost-effective alternatives with similar efficacy. Dry AMD / Geographic Atrophy (GA): - Syfovre (Pegcetacoplan): First FDA-approved therapy for GA, slows disease progression by up to 36% by inhibiting complement C3. - Izervay (Avacincaptad Pegol): Approved in 2023; targets complement C5 to reduce retinal degeneration in GA. - AREDS2 Supplements and Photobiomodulation Therapy offer supportive care for early or intermediate dry AMD. 🔬 Emerging Therapies and Pipeline Highlights The AMD pipeline is robust, focusing on durable solutions and novel mechanisms of action. For Dry AMD (GA): - ALK-001 (Alkeus Pharmaceuticals): A modified vitamin A derivative in Phase II/III trials aimed at slowing photoreceptor degeneration. - Tinlarebant (Belite Bio): Oral therapy reducing retinal vitamin A buildup to slow GA progression (Phase III). For Wet AMD: - ABBV-RGX-314 (REGENXBIO/AbbVie): Gene therapy delivering anti-VEGF via subretinal or suprachoroidal injection. Phase III underway, with potential to eliminate frequent injections. - 4D-150 (4D Molecular Therapeutics): Intravitreal gene therapy targeting VEGF-A and VEGF-C for sustained delivery—Phase III trials are ongoing. Other Novel Agents: - UBX1325 (Unity Biotechnology): Senolytic targeting aging retinal cells to improve vision in AMD and DME. - Complement Inhibitors in Development: Aimed at upstream and downstream components (e.g., CFB, CFD, FD inhibitors). Ask For Customized CI Sample Report as per Your Business Requirement: https://www.datamintelligence.com/strategic-insights/ci/age-related-macular-degeneration-amd 📈 Market Opportunities & Forecasting - The wet AMD market continues to dominate revenue, but geographic atrophy (GA) is a growing segment due to newly approved treatments and expanding patient population. - Gene therapy and biosimilars are expected to drive a paradigm shift by improving durability and lowering long-term costs. - Market revenue is projected to grow from $14.24 billion (2024) to $24.22 billion by 2033, largely fueled by treatment innovation and the rising global prevalence of AMD. 🔍 Unmet Needs: The Next Frontier in AMD Care Despite progress, critical gaps remain: - Treatment Burden: Monthly injections are unsustainable for many elderly patients. Gene therapies and extended-interval dosing are key solutions. - Lack of Cure for Dry AMD: GA treatments slow degeneration but cannot reverse damage. - Global Access & Cost: High biologic prices remain a barrier in low- and middle-income countries. Biosimilars and oral agents offer scalable alternatives. - Delayed Detection: Early AMD often goes undiagnosed. Greater emphasis on screening and AI-enabled imaging is needed. - Personalized Medicine: Genotype-based AMD therapies remain underdeveloped, despite promising biomarker research. 🏆 Competitive Landscape and Strategic Positioning Key Players in Wet AMD: - Regeneron: Market leader with Eylea/Eylea HD. Facing competition from biosimilars and Roche’s Vabysmo. - Roche/Genentech: Innovator with Vabysmo and sustained delivery devices. - Novartis: With Beovu, pursuing longer dosing intervals. Leading in Dry AMD: - Apellis (Syfovre) and Astellas/Iveric Bio (Izervay) have pioneered complement-targeted approaches. Emerging Innovators: - REGENXBIO and Adverum Biotech: Leading the charge in gene therapy, aiming to provide one-time, durable treatment solutions. - Samsung Bioepis, Biocon, Polpharma: Disrupting the pricing landscape with Lucentis and Eylea biosimilars. Book Free CI Consultation Report: https://www.datamintelligence.com/strategic-insights/ci/age-related-macular-degeneration-amd 🎯 Target Opportunity Profile (TOP): Strategic Drug Benchmarking Ideal Drug Profile: - Wet AMD: ORR > 90%, injection frequency ≤ every 16 weeks, subcutaneous/gene therapy option. - GA: ≥30% reduction in lesion growth, good safety profile, ideally oral or less invasive. - Gene Therapy: One-time treatment, durable for 2–5+ years, minimal side effects. Benchmarking Snapshot: - Eylea HD: 12–16 week interval; market leader. - Vabysmo: Dual-target; fast-growing market share. - Syfovre & Izervay: First-movers in GA. - RGX-314 & 4D-150: Future disruptors with one-time treatment potential. - Yesafili, Opuviz: Cost-effective alternatives, expanding access. 💡 Conclusion: A Clearer Vision for Millions The Age-Related Macular Degeneration (AMD) landscape is evolving from high-frequency, high-cost injection therapies toward smarter, longer-lasting, and more accessible treatments. From breakthrough gene therapies to affordable biosimilars and the first-ever drugs for geographic atrophy, this is an era defined by innovation and opportunity. As the AMD patient population swells worldwide, driven by aging demographics, these advancements are not just medically vital—they’re a necessity for sustainable and equitable eye care. Read Related CI Report: 1. Atypical Hemolytic-Uremic Syndrome Therapeutic 2. Chronic Rhinosinusitis with Nasal Polyps Sai Kumar DataM Intelligence 4market Research LLP +1 877-441-4866 sai.k@datamintelligence.com Visit us on social media: LinkedIn X Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

Phase 3Drug ApprovalGene Therapy

15 May 2025

·pharma.economictimes.indiatimes.com

Biocon plans ₹4,500-cr QIP to raise stake in Biologics unit: Kiran Shaw

Mumbai: India's biotech flagship Biocon 's profitability is being pulled down by structured venture debt prompting it to look at a fundraise of '4,500 crore to increase promoter stake in its subsidiary Biocon Biologics , Kiran Mazumdar-Shaw , chairperson, Biocon Group, told ET in an exclusive interaction. "I have a very strong business,but my profitability is being dragged down because of the structured venture debt that I took. This structured venture debt leads to a lot of provisioning and that erodes or erases your profitability," said Shaw. "My aim is to have a QIP and capital raise that can convert that structured venture debt into raised promoter equity. If I remove that, then my promoter equity of Biocon increases in Biologics." "That will then create a very strong balance sheet, and it will also create a good profitability which is what this business can do," said Shaw. Biocon Biologics acquired Viatris's global biosimilars business in 2022 for $3.3 billion. The company has been making efforts to reduce its total acquisition related debt of around $1.2 billion. Biocon operates its biosimilars business through BBL. Biocon Biologics has received investment from several entities, including True North, Tata Capital Growth Fund, Goldman Sachs, and ADQ, a sovereign wealth fund from Abu Dhabi. "I am not taking all of them back...some of them are straight equity which I will not touch but many of them are structured debt and that is what we are taking out," said Shaw, making clear her plan. She did not mention a specific timeline for the QIP but added that it will be "as soon as possible." For the quarter ended March, Biocon's net profit surged 153% to '344 crore, while consolidated total revenue was '4,454 crore, up 2 per cent over last year. "Today if I look at my business, I have 25 per cent Ebitda on a little over a billion dollars of sales right now...we have generated $260 million of Ebitda but then look at the profitability coming down due to all this provisioning...if I can remove all that it will throw up good cash and profits," she added. The company, which was earlier looking at listing its Biologics business, is now considering option to merge it with the parent company in view of the volatile market condition for an IPO. "Initially, we were obviously focused on an IPO for Biologics. Now, with all these market uncertainties, it's not the right time for an IPO," said Shaw. "So how soon will that window open? We don't know. In the interim, our board said also, look at a merger, because that could also unlock value with all the things that are going on. So, that's what we are also looking at, saying, what is a closer value unlocking opportunity, is it IPO? Or is it a merger? That's what we are looking at," she added. However, Shaw also said that ultimately the company may opt for an IPO, "but we are still also looking at a merger, and we wanted to be transparent about." Shaw also said the company aiming to be the number 3 biosimilars company in the world in the next five years. Biocon's global biosimilar launch plans over the next 12 to 18 months include aflibercept, bevacizumab, aspart and denosumab. Presently, Biocon has a portfolio of 20 biosimilars, ten of which are approved, nine have been commercialised globally of which five were launched in the US. In Q4, Biologics delivered a 9 per cent year-on-year revenue increase driven by significant market share gains in the US and key tender wins in emerging markets. On a full-year basis, the company posted a 15 per cent growth in FY25. It is set for five new product launches in the next 12-18 months and expanding patient access. In FY25, biosimilars continued to build shares in global markets with four biosimilars recording sales of $200 million each. By Rica Bhattacharyya & Vikas Dandekar ,

AcquisitionIPO

100 Deals associated with AFLIBERCEPT-JBVF

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Indication	Country/Location	Organization	Date
Vision, Low	Canada	Biocon Biologics Ltd. (India)	27 Jun 2025
Diabetic Retinopathy	United States	Biocon Biologics, Inc.	20 May 2024
Diabetic macular oedema	European Union	Biocon Biologics Ireland Ltd.	15 Sep 2023
Diabetic macular oedema	Iceland	Biocon Biologics Ireland Ltd.	15 Sep 2023
Diabetic macular oedema	Liechtenstein	Biocon Biologics Ireland Ltd.	15 Sep 2023
Diabetic macular oedema	Norway	Biocon Biologics Ireland Ltd.	15 Sep 2023
Myopic choroidal neovascularization	European Union	Biocon Biologics Ireland Ltd.	15 Sep 2023
Myopic choroidal neovascularization	Iceland	Biocon Biologics Ireland Ltd.	15 Sep 2023
Myopic choroidal neovascularization	Liechtenstein	Biocon Biologics Ireland Ltd.	15 Sep 2023
Myopic choroidal neovascularization	Norway	Biocon Biologics Ireland Ltd.	15 Sep 2023
Retinal vein occlusion-related macular edema	European Union	Biocon Biologics Ireland Ltd.	15 Sep 2023
Retinal vein occlusion-related macular edema	Iceland	Biocon Biologics Ireland Ltd.	15 Sep 2023
Retinal vein occlusion-related macular edema	Liechtenstein	Biocon Biologics Ireland Ltd.	15 Sep 2023
Retinal vein occlusion-related macular edema	Norway	Biocon Biologics Ireland Ltd.	15 Sep 2023
Wet age-related macular degeneration	European Union	Biocon Biologics Ireland Ltd.	15 Sep 2023
Wet age-related macular degeneration	Iceland	Biocon Biologics Ireland Ltd.	15 Sep 2023
Wet age-related macular degeneration	Liechtenstein	Biocon Biologics Ireland Ltd.	15 Sep 2023
Wet age-related macular degeneration	Norway	Biocon Biologics Ireland Ltd.	15 Sep 2023

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03610646 (not provided, Pubmed \| JAMA Ophthalmol)	Phase 3	Diabetic macular oedema	355	MYL-1701P	qfjcxxfkov(xhiguxtxrw) = bbyjaaigxx hcyfpbeybd (kzfwzbynbs, 0.55) View more	Positive	12 Sep 2024
				Aflibercept	qfjcxxfkov(xhiguxtxrw) = quoqafbuww hcyfpbeybd (kzfwzbynbs, 0.55) View more
FDA_CDER Manual	Not Applicable	Diabetic Retinopathy	297	Aflibercept 2 mg Q8 weeks	obpyinnmjx(swklrohzum) = txeajufghm rkjspcilrl (hvknlmjqlp )	Positive	20 May 2024
				Aflibercept 2 mg Q4 weeks	obpyinnmjx(swklrohzum) = vmclohmmgf rkjspcilrl (hvknlmjqlp )
FDA_CDER Manual	Phase 3	Retinal vein occlusion-related macular edema	187	Aflibercept 2 mg Q4 weeks	rdabrpbvdc(xvmfaikzpw) = agxubofspx nuxuqhobrl (tpjhgzhkbt ) View more	Superior	20 May 2024
FDA_CDER Manual	Phase 3	Wet age-related macular degeneration	905	Aflibercept 2 mg Q8 weeks	zfrksebifr(mnyiqclpkh) = psjmlqtrnd ffytwzgakb (ioevxxltap ) View more	Positive	20 May 2024
				Aflibercept 2 mg Q4 weeks	zfrksebifr(mnyiqclpkh) = wagmynnudi ffytwzgakb (ioevxxltap ) View more
FDA_CDER Manual	Phase 3	Retinal vein occlusion-related macular edema	181	Aflibercept 2 mg Q4 weeks	galmgaooua(dokncvvsjg) = zqyqexfmsu igzystxxta (nzbhsalujt ) View more	Superior	20 May 2024
FDA_CDER Manual	Phase 3	Diabetic macular oedema	459	Aflibercept 2 mg Q8	vrkclruorn(cnzisyzfxn) = ypoxjayvsz rhqxhnbwxw (zgvdhgedjr, 8.2) View more	Positive	20 May 2024
				Aflibercept 2 mg Q4 weeks	vrkclruorn(cnzisyzfxn) = anfgqqvmfg rhqxhnbwxw (zgvdhgedjr, 9.5) View more
FDA_CDER Manual	Not Applicable	Diabetic Retinopathy	451	Aflibercept 2 mg Q8 weeks	wstqzhwohb(qimjshgxop) = mfzrbynkdx dbgwtxotoi (mbrvuhojah )	Positive	20 May 2024
				Aflibercept 2 mg Q4 weeks	wstqzhwohb(qimjshgxop) = ihmoworaof dbgwtxotoi (mbrvuhojah )
FDA_CDER Manual	Phase 3	Wet age-related macular degeneration	906	Aflibercept 2 mg Q8 weeks	fjiamdrypf(ptamoiveuz) = pmvehnmroz fueanxkhjb (cbovmwekhz ) View more	Positive	20 May 2024
				Aflibercept 2 mg Q4 weeks	fjiamdrypf(ptamoiveuz) = aelkphhjza fueanxkhjb (cbovmwekhz ) View more
FDA_CDER Manual	Phase 3	Retinal vein occlusion-related macular edema	171	Aflibercept 2 mg Q4 weeks	bnbqdgjvun(ivnusvdaat) = pysyxdjgqh kdbtjkudch (xhrlngmazh ) View more	Superior	20 May 2024
FDA_CDER Manual	Phase 3	Diabetic macular oedema	403	Aflibercept 2 mg Q8 weeks	namjnlfngz(qmwmdazjfz) = fjygamelun wcgfrmchet (dqhmgtkerr, 9.3) View more	Positive	20 May 2024
				Aflibercept 2 mg Q4 weeks	namjnlfngz(qmwmdazjfz) = qvjmyxodfv wcgfrmchet (dqhmgtkerr, 9.6) View more

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