- After a single intravitreal dose of 4D-150, visual acuity and anatomic control was maintained with consistent and durable treatment burden reduction through 2 years
- 4D-150 continues to be well tolerated with no new safety or intraocular inflammation findings
EMERYVILLE, Calif., July 18, 2026 (GLOBE NEWSWIRE) — 4D Molecular Therapeutics (Nasdaq: FDMT, 4DMT or the Company), a leading late-stage biotechnology company advancing durable and disease-targeted therapeutics with potential to transform treatment paradigms and provide unprecedented benefits to patients, today announced positive 2-year data from the PRISM Phase 2b clinical trial evaluating 4D-150 in a broad wet age-related macular degeneration (wet AMD) population. The data were presented by Carl Awh, M.D., FASRS, Tennessee Retina, in an oral presentation titled “2-Year Follow Up: PRISM Phase 2b Clinical Trial Evaluating Investigational 4D-150, an Intravitreal Gene Therapy, in a Broad Neovascular AMD Population” at the 44th Annual Scientific Meeting of the American Society of Retina Specialists (ASRS).
2-Year Data from PRISM Phase 2b Clinical Trial (Data Cutoff May 18, 2026):
Trial and Patient Cohort Overview
- The Phase 2b trial enrolled 45 patients at two dose levels of a single intravitreal dose of 4D-150 (3E10 and 1E10 vg/eye); 3E10 vg/eye was chosen as the dose for the 4FRONT Phase 3 clinical trials
- The Phase 2b overall cohort enrolled patients with broad disease activity (n=30 dosed with 3E10 vg/eye and n=15 dosed with 1E10 vg/eye)
- The Phase 2b cohort subgroup comprised recently diagnosed patients (diagnosed within 6 months, n=15 at 3E10 vg/eye), which is most comparable to the population enrolled in the 4FRONT Phase 3 clinical trials
Phase 2b Efficacy Results Through 2 Years:
- Consistent maintenance of best corrected visual acuity (BCVA)
- Consistent control of central subfield thickness (CST) as measured by optical coherence tomography
- Consistent, durable and clinically meaningful reduction in treatment burden:
- Overall cohort:
- 78% overall treatment burden reduction (2.7 mean supplemental injections per patient vs. 12.0 injections projected with on-label aflibercept 2 mg Q8W)
- Recently diagnosed subgroup:
- 87% overall treatment burden reduction (1.6 mean supplemental injections per patient vs. 12.0 injections projected with on-label aflibercept 2 mg Q8W)
- Overall cohort:
- Dose response maintained throughout 2 years in favor of the Phase 3 dose
Safety Data for Phase 3 Dose in Overall PRISM Phase 1/2a & 2b Clinical Trial (n=71)
- 4D-150 continues to be well tolerated:
- Intraocular inflammation:
- As previously reported, within approximately the first 6 months (28 weeks) post-4D-150 dosing, 2.8% (2 of 71) of patients had 4D-150-related 1+ (mild) intraocular inflammation (IOI) (SUN/NEI scales), which were transient 1+ vitreous cells noted at a single timepoint
- Following the first 28 weeks post-4D-150 dosing, no new cases of inflammation with 2 to more than 4 years of follow-up on all patients as of the data cutoff
- No 4D-150-related hypotony, endophthalmitis, vasculitis, occlusive/non-occlusive retinal vasculitis or choroidal effusions observed to date
- Intraocular inflammation:
“Two-year PRISM data continue to strengthen our conviction in 4D-150’s potential to become a foundational backbone therapy for wet AMD,” said David Kirn, M.D., Co-founder, President, and Chief Executive Officer of 4DMT. “The continued consistency in visual acuity and anatomic control with meaningful reduction in treatment burden and long-term tolerability reinforces our confidence in delivering a transformative treatment option for retina specialists and their patients.”
“For retina specialists and our patients, maintaining the intensive injection schedule necessary to preserve vision is a tremendous challenge,” said Carl Awh, M.D., FASRS, Tennessee Retina. “The two-year PRISM results demonstrate the potential of a single intravitreal administration of 4D-150 to provide long-term anti-VEGF and sustained disease control. Reducing treatment burden will undoubtedly improve our ability to preserve vision over the long term for our patients.”
The presentation from ASRS is available on the 4DMT website under Scientific Presentations.
About 4D-150
4D-150 is a potential backbone therapy designed to provide multi-year, and potentially lifelong, sustained delivery of anti-VEGF biologics (aflibercept and anti-VEGF-C) within the retina following a single intravitreal injection. 4D-150 utilizes our customized and evolved intravitreal AAV vector, R100, which was invented at 4DMT through our proprietary Therapeutic Vector Evolution platform. 4D-150 is being developed for wet AMD and diabetic macular edema (DME), which both affect millions of patients globally, with the goal of freeing patients from burdensome injections while preserving vision.
About Wet AMD
Wet AMD, or wet age-related macular degeneration, is a highly prevalent disease, with more than 4 million individuals expected to be affected in the next five years in certain major markets, including the U.S., the EU and Japan. The disease also has a high incidence, with 200,000 individuals estimated to be newly diagnosed every year in the U.S. alone. Wet AMD is a type of macular degeneration in which abnormal blood vessels grow into the macula (macular neovascularization or MNV), the central area of the retina. MNV causes swelling and edema of the retina, bleeding and scarring, leading to visual distortion and reduced visual acuity. The proliferation and leakage of abnormal blood vessels is stimulated by VEGF. This process distorts and, without treatment, can potentially destroy central vision and may progress to blindness.
About 4DMT
4DMT is a leading late-stage biotechnology company advancing durable and disease-targeted therapeutics with potential to transform treatment paradigms and provide unprecedented benefits to patients. The Company’s lead product candidate 4D-150 is designed to be a backbone therapy forming the foundation of treatment of blinding retinal vascular diseases by providing multi-year sustained delivery of anti-VEGF biologics (aflibercept and anti-VEGF-C) with a single intravitreal injection, which substantially reduces the treatment burden associated with current bolus injections. The Company’s lead indication for 4D-150 is wet age-related macular degeneration, which is currently in Phase 3 development, and second indication is diabetic macular edema. The Company’s second product candidate is 4D-710, which is the first known genetic medicine to demonstrate successful delivery and expression of the CFTR transgene in the lungs of people with cystic fibrosis after aerosol delivery. 4D Molecular Therapeutics™, 4DMT™, Therapeutic Vector Evolution™, Backbone 4 Retina™ and the 4DMT logo are trademarks of 4DMT.
All of the Company’s product candidates are in clinical or preclinical development and have not yet been approved for marketing by the U.S. Food and Drug Administration or any other regulatory authority. No representation is made as to the safety or effectiveness of the Company’s product candidates for the therapeutic uses for which they are being studied.
Learn more at www.4DMT.com and follow us on LinkedIn.
Forward-Looking Statements:
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, implied and express statements regarding the therapeutic potential, treatment-burden reduction, durability, clinical development plans, regulatory timing, and success of clinical trials for 4D-150. The words “may,” “might,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “seek,” “predict,” “future,” “project,” “potential,” “continue,” “target” and similar words or expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including risks and uncertainties that are described in greater detail in the section entitled “Risk Factors” in 4D Molecular Therapeutics’ most recent Quarterly Report on Form 10-Q filed on May 7, 2026, as well as any subsequent filings with the Securities and Exchange Commission. In addition, any forward-looking statements represent 4D Molecular Therapeutics’ current views and should not be relied upon as representing its views as of any subsequent time. 4D Molecular Therapeutics explicitly disclaims any obligation to update any forward-looking statements. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements.
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