4D Molecular Therapeutics (4DMT) has entered into a strategic partnership with Otsuka Pharmaceutical Co., Ltd. to develop and commercialize its lead gene therapy candidate 4D-150 for retinal vascular diseases across the Asia-Pacific region. The agreement, announced on October 30, 2025, provides 4DMT with an immediate $85 million upfront cash payment and expected cost sharing of at least $50 million over the next three years for global development activities.
Under the licensing agreement, Otsuka gains exclusive rights to develop and commercialize 4D-150 for wet age-related macular degeneration (wet AMD) and diabetic macular edema (DME) in Japan, China, Australia, and other Asia-Pacific markets. The partnership positions both companies to address significant unmet medical needs in a region where wet AMD is expected to affect more than 4 million individuals in the next five years across major markets including the U.S., EU, and Japan.
Financial Structure and Development Timeline
The comprehensive deal structure includes up to $336 million in potential regulatory and commercial milestone payments, along with tiered double-digit royalties based on net sales in Otsuka's territories. 4DMT retains full development and commercialization rights for 4D-150 outside the APAC region, including the United States, Latin America, and Europe.
4DMT will continue to lead all Phase 3 clinical activities globally, including within the APAC region. APAC clinical sites in 4FRONT-2, the global Phase 3 study in wet AMD, are expected to open by the end of 2025, with Japan sites anticipated to begin operations in January 2026. Otsuka will assume responsibility for all regulatory and commercialization activities within its licensed territories.
Therapeutic Innovation and Market Impact
4D-150 represents a potentially transformative approach to treating retinal vascular diseases through its design as a backbone therapy providing multi-year, and potentially lifelong, sustained delivery of anti-VEGF agents (aflibercept and anti-VEGF-C) from a single intravitreal injection. The therapy utilizes 4DMT's customized and evolved intravitreal AAV vector, R100, developed through the company's proprietary Therapeutic Vector Evolution platform.
"We are thrilled to announce this strategic partnership with Otsuka, a leading global pharmaceutical company with a strong presence in the APAC region, reflecting our shared long-term commitment to improving outcomes for patients with retinal vascular diseases," said David Kirn, M.D., Co-founder and Chief Executive Officer of 4DMT.
The therapy aims to address significant treatment burden issues in current care paradigms. DME, which affects approximately one million individuals in the U.S., is typically treated with intravitreal anti-VEGF agents administered every 4-16 weeks, though patient compliance with therapy remains poor, resulting in high unmet medical need.
Regional Market Dynamics
Chris Simms, Chief Commercial Officer of 4DMT, emphasized the strategic importance of the APAC region: "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 we expect Otsuka's deep presence and expertise to accelerate both development of and access to 4D-150."
Wet AMD demonstrates significant disease burden globally, with 200,000 individuals estimated to be newly diagnosed every year in the U.S. alone. The condition involves abnormal blood vessel growth into the macula, causing swelling, bleeding, and scarring that can lead to visual distortion and potentially progress to blindness without treatment.
Makoto Inoue, President and Representative Director of Otsuka Pharmaceutical Co., Ltd., stated: "By introducing 4D-150 to the markets in Japan, and elsewhere in Asia and Oceania, we aim to help prevent vision loss through a single, potentially lifelong administration."
The proceeds and cost sharing from this partnership are expected to support 4DMT's global Phase 3 clinical trial in DME and pre-commercial activities, positioning the company to advance its gene therapy platform across multiple indications in retinal vascular diseases.
