4DMT and Otsuka Pharmaceutical partner on 4D-150 in the greater Asia-Pacific region

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 (wet AMD) and diabetic macular edema (DME) in the greater Asia-Pacific (APAC) region, including Japan.

According to the company, under the terms of the agreement, 4DMT will grant Otsuka exclusive rights to develop and commercialize 4D-150 for retinal vascular diseases in Japan, China, Australia, and other Asia-Pacific markets. Additionally, Otsuka will lead all regulatory and commercialization activities in its licensed territories.

4DMT will receive an upfront cash payment of $85 million as well as expected cost sharing of at least $50 million over the next 3 years for global development activities and is eligible for up to $336 million in potential regulatory and commercial milestone payments. 4DMT will retain full development and commercialization rights for 4D-150 outside the APAC region, including the US, Latin America, and Europe.

4D-150 is an investigational agent designed to provide multi-year sustained delivery of anti-VEGF (aflibercept and anti-VEGF-C) from the retina with a single, safe, intravitreal injection. It utilizes the company’s customized and evolved intravitreal vector, R100.

Recently, the company announced positive results from the SPECTRA clinical trial evaluating 4D-150 in patients with DME.

The study enrolled 22 patients across 3 dose levels, including the phase 3 dose of 3E10 vg/eye (n=9) and supplemental doses of 1E10 vg/eye (n=12) and 5E9 vg/eye (n=1). It was noted that 2 patients dosed in the 1E10 vg/eye missed over 50% of study visits and were considered not evaluable for injection burden or other efficacy parameters.

According to the data, 4D-150 is well-tolerated with no intraocular inflammation at any timepoint over 60 weeks. Additionally, no patients required any modification to the topical corticosteroid regimen.

David Kirn, MD, co-founder and CEO of 4DMT, as well as Makoto Inoue, president and representative director of Otsuka Pharmaceutical, commented on the partnership in a press release.

“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 Kirn. “This partnership is a key pillar of our global strategy, with 4DMT continuing to lead Phase 3 clinical trial and manufacturing activities globally, in addition to pre-commercial and commercial activities outside the APAC region.”

“Otsuka has created new value that contributes to the well-being of patients in Japan and around the world through both in-house and collaborative research. 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,” added Inoue.

References:

1. 4DMT Announces Exclusive License Agreement with Otsuka Pharmaceutical Co., Ltd. for Development and Commercialization of 4D-150 in Asia-Pacific. Published October 30 2025. Accessed November 3, 2025. https://ir.4dmoleculartherapeutics.com/news-releases/news-release-details/4dmt-announces-exclusive-license-agreement-otsuka-pharmaceutical

2. 4DMT announces positive results from SPECTRA trial evaluating 4D-150 in patients with DME. Published August 4, 2025. Accessed November 3, 2025. https://www.ophthalmologytimes.com/view/4dmt-announces-positive-results-from-spectra-trial-evaluating-4d-150-in-patients-with-dme