4DMT Secures $420M Deal with Otsuka for Retinal Gene Therapy Rights

4D Molecular Therapeutics (4DMT) has announced a significant partnership with Otsuka Pharmaceutical, selling the Asia-Pacific rights to its promising eye gene therapy, 4D-150. The deal, valued at up to $420 million, provides 4DMT with substantial funding to advance the therapy's phase 3 development for retinal vascular diseases.

Deal Structure and Financial Terms

Under the agreement, 4DMT will receive $85 million in upfront cash from Otsuka. The Japanese pharmaceutical company will also contribute at least $50 million over the next three years for global development activities. Additionally, the deal includes potential regulatory and commercial milestone payments of up to $336 million, along with tiered double-digit royalties on future sales.

In exchange, Otsuka gains the rights to develop and commercialize 4D-150 for conditions such as wet age-related macular degeneration (AMD) and diabetic macular edema (DME) in Japan, China, Australia, and other Asia-Pacific markets.

4D-150: A Promising Gene Therapy for Retinal Diseases

4D-150 is designed to provide sustained delivery of anti-VEGF agents, potentially improving patient outcomes and reducing the burden of frequent injections. The therapy encodes aflibercept—the active ingredient in Regeneron's Eylea—and a sequence that inhibits VEGF-C expression.

Recent phase 2 trial data for 4D-150 showed promising results, with a 78% reduction in supplemental injections for patients receiving the phase 3 dose compared to projected on-label use of Eylea 2 mg. The gene therapy is currently in a phase 3 trial for wet AMD, with plans for an additional late-stage study in DME.

Strategic Implications and Market Potential

David Kirn, M.D., CEO of 4DMT, emphasized the strategic importance of the partnership, stating, "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."

Chris Simms, 4DMT's Chief Commercial Officer, highlighted the significant market opportunity in the Asia-Pacific region, noting its high prevalence of wet AMD and DME. The collaboration with Otsuka is expected to accelerate both the development of and access to 4D-150 in these underserved markets.