4DMT and Otsuka Partner on 4D-150 Gene Therapy in APAC

4D Molecular Therapeutics (4DMT) has entered a strategic collaboration with Otsuka Pharmaceutical to develop and commercialize 4D-150, a gene therapy candidate for wet age-related macular degeneration (AMD) and diabetic macular edema (DME), across the greater Asia-Pacific (APAC) region, including Japan. The partnership combines 4DMT’s genetic medicine platform with Otsuka’s regional infrastructure to accelerate development and access in APAC.

Strategic Alliance to Address Retinal Vascular Diseases in APAC

The newly announced partnership brings together 4DMT’s proprietary expertise in adeno-associated virus (AAV) gene therapy, retinal disease development, and advanced manufacturing, with Otsuka’s well-established regulatory, clinical, and commercial operations in Asia-Pacific markets. The primary goal of the collaboration is to achieve global marketing approval and widespread commercialization of 4D-150, a gene therapy designed to offer long-lasting benefits to patients with retinal vascular diseases.

Terms of the Agreement and Regional Responsibilities

Under the agreement, 4DMT will grant Otsuka exclusive rights to develop and commercialize 4D-150 in Japan, China, Australia, and other APAC territories. Otsuka will be responsible for all regulatory and commercialization activities within these markets. Meanwhile, 4DMT will continue to lead all global Phase 3 clinical activities, including those within the APAC region.

Enrollment for clinical sites in the 4FRONT-2 global Phase 3 study for wet AMD is expected to begin in the APAC region by the end of 2025, with Japanese sites starting in early 2026.

Financial Terms and Global Rights Retention

As part of the collaboration, 4DMT will receive an upfront payment of $85 million. Additionally, Otsuka will provide at least $50 million in cost-sharing over the next three years to support global development efforts. 4DMT is also eligible for up to $336 million in regulatory and commercial milestone payments and will receive tiered double-digit royalties on net sales in Otsuka’s licensed territories.

Importantly, 4DMT retains full rights to 4D-150 outside of the APAC region, including in the United States, Europe, and Latin America.

Addressing a High-Unmet Need in the APAC Retina Market

Chris Simms, Chief Commercial Officer of 4DMT, emphasized the significance of the APAC market:
“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.”

About 4D-150

4D-150 is an investigational gene therapy designed to deliver multi-year or potentially lifelong therapeutic benefit through a single intravitreal injection. It targets both VEGF-A (aflibercept) and VEGF-C to reduce the frequency of injections required to treat wet AMD and DME, while maintaining or improving visual outcomes.

The therapy is powered by 4DMT’s proprietary R100 vector, developed using the company’s Therapeutic Vector Evolution platform, and is optimized for safe and effective intravitreal delivery.