Aflibercept

EMERYVILLE, CA, USA I July 02, 2025 I 4D Molecular Therapeutics (Nasdaq: FDMT, 4DMT or the Company), a leading late-stage biotechnology company advancing durable and disease-targeted therapeutics with potential to transform treatment paradigms and provide unprecedented benefits to patients, today announced the acceleration of the 4D-150 4FRONT Phase 3 program in wet age-related macular degeneration (wet AMD). The Company also has streamlined operations to offset additional expenses expected based on the accelerated timelines for the 4FRONT clinical trials and BLA preparation, which supports the Company’s cash runway into 2028, as previously guided. The transition reflects the Company’s focus on its late-stage pipeline, a strategy previously announced in January 2025. Company Streamlined to Drive Accelerated Phase 3 Development “We are thrilled with the strong interest in 4D-150 from investigators and patients in both 4FRONT Phase 3 studies, reflecting their belief in the Phase 1/2 data demonstrating the tolerability and robust, durable clinical activity of this potential foundational backbone therapy for retinal vascular diseases. This progress also confirms our belief that durable treatment burden reduction is the greatest unmet need for these patients. As a result, we now anticipate topline data for 4FRONT-1 in the first half of 2027,” said Dhaval Desai, Chief Development Officer of 4DMT. “We have aligned our resources to deliver on our mission of bringing transformative and durable genetic medicines to millions of patients in need, with a focus on 4D-150 for wet AMD, in our ongoing transition to becoming a commercial company,” said David Kirn, M.D., Co-founder and Chief Executive Officer of 4DMT. “I want to express my deep gratitude and respect for the talented colleagues whose work has been critical to 4DMT’s success to date, who we thank sincerely for their dedication to and passion for our mission.” About 4D-150 4D-150 is a potential backbone therapy that is designed to provide multi-year sustained delivery of anti-VEGF (aflibercept and anti-VEGF-C) from the retina with a single, safe, intravitreal injection. 4D-150 utilizes the Company’s customized and evolved intravitreal vector, R100, which was invented at 4DMT through the Company’s proprietary Therapeutic Vector Evolution platform. 4D-150 is being developed for wet AMD and DME, which both affect millions of patients globally, with the goal of freeing patients from burdensome injections while preserving vision. About Wet AMD Wet AMD is a highly prevalent disease, with more than 4 million individuals expected to be affected in the next five years in certain major markets, including the U.S., the EU and Japan. The disease also has a high incidence, with 200,000 individuals estimated to be newly diagnosed every year in the U.S. alone. Wet AMD is a type of macular degeneration in which abnormal blood vessels grow into the macula (macular neovascularization or MNV), the central area of the retina. MNV causes swelling and edema of the retina, bleeding and scarring, leading to visual distortion and reduced visual acuity. The proliferation and leakage of abnormal blood vessels is stimulated by VEGF. This process distorts and, without treatment, can potentially destroy central vision and may progress to blindness. About 4DMT 4DMT is a leading late-stage biotechnology company advancing durable and disease-targeted therapeutics with potential to transform treatment paradigms and provide unprecedented benefits to patients. The Company’s lead product candidate 4D-150 is designed to be a backbone therapy forming the foundation of treatment of blinding retinal vascular diseases by providing multi-year sustained delivery of anti-VEGF (aflibercept and anti-VEGF-C) with a single, safe, intravitreal injection, which substantially reduces the treatment burden associated with current bolus injections. The Company’s lead indication for 4D-150 is wet age-related macular degeneration, which is currently in Phase 3 development, and second indication is diabetic macular edema. The Company’s second product candidate is 4D-710, which is the first known genetic medicine to demonstrate successful delivery and expression of the CFTR transgene in the lungs of people with cystic fibrosis after aerosol delivery. 4D Molecular Therapeutics™, 4DMT™, Therapeutic Vector Evolution™, and the 4DMT logo are trademarks of 4DMT. All of the Company’s product candidates are in clinical or preclinical development and have not yet been approved for marketing by the U.S. Food and Drug Administration or any other regulatory authority. No representation is made as to the safety or effectiveness of the Company’s product candidates for the therapeutic uses for which they are being studied. Learn more at www.4DMT.com and follow us on LinkedIn . SOURCE: 4DMT

TORONTO, July 2, 2025 /PRNewswire/ - Apotex Inc. ("Apotex" or the "Company"), the Canadian-based global health company, today announced that Health Canada has approved Aflivu™ (aflibercept), a biosimilar to Eylea®, indicated for the treatment of neovascular (wet) age-related macular degeneration, macular edema secondary to central or branch retinal vein occlusion, treatment of diabetic macular edema, and treatment of myopic choroidal neovascularization. This approval marks a key milestone for Apotex, introducing its first ophthalmic biosimilar and its fourth biosimilar since 2016, and reflecting the Company's commitment to expand its biologics portfolio and execution of its Journey of Health strategy. "With Aflivu, we're expanding affordable treatment options for Canadians affected by retinal diseases," said Raymond Shelley, President, Apotex Canada. "Apotex continues to deliver innovative, patient-focused solutions across our growing portfolio of brands, biosimilars, generics and consumer health products." "The approval of Aflivu represents a positive advancement in ophthalmic care," said Dr. Bernard R. Hurley, BSc, MD, FRCSC, Assistant Professor at the University of Ottawa Eye Institute. "Biosimilars, supported by clinicians, regulators, and manufacturers, have the potential to transform the treatment landscape for retinal diseases, preserving vision and providing quality, cost-effective care for countless Canadians." "In clinical practice, having access to a broader range of therapeutic options can empower physicians to tailor care to individual patients' needs," said Dr. Ghassan Cordahi, MD, FACS, Assistant Clinical Professor, Faculty of Medicine, Department of Ophthalmology, Université de Montréal. "Aflibercept has been a cornerstone in managing retinal diseases, and the introduction of Aflivu offers a more affordable alternative without compromising quality." Aflivu joins Apotex's successful biosimilar portfolio, which includes Grastofil® (filgrastim), Lapelga® (pegfilgrastim), and Bambevi® (bevacizumab). About Apotex Apotex is a Canadian-based global health company. We improve everyday access to affordable, innovative medicines and health products for millions of people around the world, with a broad portfolio of generic, biosimilar, and innovative branded pharmaceuticals, and consumer health products. Headquartered in Toronto, with regional offices globally, including in the United States, Mexico, and India, we are the largest Canadian-based pharmaceutical company and a health partner of choice for the Americas for pharmaceutical licensing and product acquisitions. Learn more about us at SOURCE Apotex Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED