AFLIBERCEPT-JBVF

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 ,

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.