4DMT and Otsuka Announce Strategic Partnership to Advance 4D-150 Gene Therapy Across Asia-Pacific
4D Molecular Therapeutics (4DMT) announced a strategic partnership with Otsuka Pharmaceutical to develop and commercialize 4D-150 for the treatment of wet age-related macular degeneration (AMD) and diabetic macular edema (DME) across the greater Asia-Pacific (APAC) region, including Japan.
According to the companies, the collaboration unites 4DMT’s proprietary expertise in adeno-associated virus (AAV) genetic medicine, retinal disease development, and advanced manufacturing with Otsuka’s established regulatory, clinical, and commercial infrastructure in key APAC markets. Together, the companies aim to secure global marketing approval and commercialization for 4D-150, a gene therapy candidate designed to deliver long-lasting benefit to patients suffering from retinal vascular diseases.
Under the agreement, 4DMT will grant Otsuka exclusive rights to develop and commercialize 4D-150 for retinal vascular diseases, including wet AMD and DME, in Japan, China, Australia, and other APAC markets. Otsuka will oversee regulatory and commercialization efforts in its territories, while 4DMT will continue to lead all global phase 3 clinical activities, including those within APAC. Enrollment for clinical sites in 4FRONT-2, the global phase 3 study in wet AMD, is expected to begin in the region by the end of 2025, with Japan sites launching in early 2026.
Under the terms of the agreement, 4DMT will receive an upfront payment of $85 million and cost-sharing support of at least $50 million over the next 3 years to fund global development activities. The company is also eligible for up to $336 million in regulatory and commercial milestone payments and will receive tiered double-digit royalties based on net sales in Otsuka’s licensed territories. 4DMT retains full rights to 4D-150 outside APAC, including in the United States, Europe, and Latin America.
“APAC represents a large and underserved retina market, with a high prevalence of wet AMD and DME. Navigating the region’s regulatory and patient-access complexities requires a strong local partner, and Otsuka’s deep expertise will accelerate both development of and access to 4D-150,” said Chris Simms, Chief Commercial Officer of 4DMT.
4D-150 is gene therapy candidate designed to provide multi-year or potentially lifelong sustained delivery of anti-VEGF (aflibercept and anti-VEGF-C) directly from the retina via a single intravitreal injection. It utilizes 4DMT’s proprietary R100 vector, engineered through the company’s Therapeutic Vector Evolution platform, optimized for safe and efficient intravitreal delivery. 4D-150 is being developed to treat wet AMD and DME, aiming to reduce the need for frequent injections while maintaining or improving vision.