image credit- shutterstock
4D Molecular Therapeutics has announced a strategic partnership with Otsuka Pharmaceutical to develop and commercialise 4D-150 for the treatment of wet age-related macular degeneration (wet AMD) and diabetic macular edema (DME) in the greater Asia-Pacific (APAC) region including Japan.
The strategic partnership combines 4DMT’s expertise in AAV genetic medicine, development in retina and manufacturing with Otsuka’s strong development expertise, regulatory experience and commercial infrastructure across APAC markets. Together, the companies aim to receive 4D-150 marketing approval and commercialisation in major markets globally. 4D-150 is a potentially transformative backbone therapy providing durable benefit in retinal vascular diseases such as wet AMD and DME, which are among the leading causes of blindness in the world.
Under the terms of 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 Asia-Pacific markets. Otsuka will lead all regulatory and commercialization activities in its licensed territories. 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 end of year, with Japan sites expected to open in January 2026.
4DMT will receive an upfront cash payment of $85 million and expected cost sharing of at least $50 million over the next three years for global development activities. In addition, the Company is eligible for up to $336 million in potential regulatory and commercial milestone payments and tiered double-digit royalties depending on net sales in Otsuka’s territories. 4DMT retains full development and commercialization rights for 4D-150 outside the APAC region, including the US, Latin America and Europe.
