- 4FRONT-2 global enrollment completed approximately 4 months ahead of initial projections
- 4FRONT-2 over-enrolled (anticipated N>500), with final patient randomization expected in Q3 2026, reflecting strong interest from investigators and patients
- 4FRONT-2 52-week topline data is expected in H2 2027
EMERYVILLE, Calif., June 29, 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 enrollment completion for 4FRONT-2, the second Phase 3 clinical trial in our global program, evaluating 4D-150 in patients with wet age-related macular degeneration (wet AMD).
"Completing global enrollment in both 4FRONT-1 and 4FRONT-2 Phase 3 trials with over-enrollment and ahead of initial projections further validates 4D-150 as the potential cornerstone of a transformative, category-defining retina franchise at 4DMT," said David Kirn, M.D., Co-founder, President and Chief Executive Officer of 4DMT. "The high enrollment rate across both 4FRONT-1 and 4FRONT-2 trials, predominantly in treatment-naïve patients, reflects the enthusiasm of patients and retina physicians for 4D-150, as well as the high unmet medical need for a vision-preserving durable backbone therapy in wet AMD. With two Phase 3 readouts expected in 2027 and initiation of a Phase 3 trial in diabetic macular edema in the third quarter of this year, we are rapidly advancing our vision of 4D-150 as the potential backbone therapy for patients with large-market retinal vascular diseases worldwide."
"Wet AMD remains a leading cause of vision loss worldwide, and despite important advances in bolus anti-VEGF therapy, most patients still continue to face the real-world burden of frequent, lifelong injections and the associated risk of undertreatment and vision loss," said Julie Clark, M.D., Chief Medical Officer of 4DMT. "The completion of enrollment in 4FRONT-2 brings us one step closer to confirming the clinical evidence that 4D-150 can meaningfully reduce treatment burden while preserving vision outcomes. We are deeply grateful to the patients, investigators, study coordinators and sites around the world who have made this trial possible."
"As retina specialists, we see every day how the need for frequent intravitreal injections can create an unsustainable burden for many patients, caregivers and practices, and how missed or delayed treatments frequently put vision at risk," said Patricio G. Schlottmann, M.D., Director of the Research Department at the Charles Ophthalmic Center, Ophthalmology Department Director at Organización Médica de Investigación in Buenos Aires, Argentina, member of the 4DMT Retinal Advisory Board and a principal investigator in the 4FRONT-2 clinical trial. "The vision for 4D-150 is compelling because it aims to move wet AMD care beyond repeated bolus injections toward durable, continuous disease control with a single intravitreal administration as the backbone treatment. Based on the clinical data generated to date, I believe 4D-150 has the potential to represent an important paradigm shift for patients and physicians if the ongoing Phase 3 program is successful. I look forward to the topline results in 2027."
4FRONT-2 is a global Phase 3 multicenter, randomized, double-masked, aflibercept 2 mg (Q8W) comparator-controlled study of intravitreal 4D-150 in wet AMD that has enrolled both treatment-naïve and recently diagnosed treatment-experienced patients. The primary endpoint is non-inferiority in the mean change from baseline in best corrected visual acuity (BCVA) at 52 weeks. The key secondary endpoint is treatment burden reduction comparing the number of aflibercept injections received in the 4D-150 arm versus the aflibercept comparator arm over 52 weeks. Patients in both arms are eligible for supplemental aflibercept injections. 4FRONT-2 52-week topline data is expected in H2 2027. 4FRONT-1, the first 4D-150 wet AMD Phase 3 trial, is being conducted in North America evaluating treatment-naïve patients with an otherwise identical design to 4FRONT-2. 4FRONT-1 52-week topline data is expected in H1 2027.
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 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 and clinical benefits of, as well as the plans, announcements and related timing for the clinical development, regulatory interactions, and potential commercialization of our product candidates, including 4D-150. The words "may," "might," "will," "could," "would," "should," "expect," "plan," "anticipate," "intend," "believe," "expect," "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: (i) risks that clinical trial results may not support regulatory approval or demonstrate sustained therapeutic benefit; (ii) risks that our product candidates may not demonstrate sufficient safety or efficacy; (iii) risks related to regulatory approval processes and evolving standards for gene therapies; (iv) risks that 4D Molecular Therapeutics may not receive necessary funding or may require additional capital for its operations and anticipated commercialization; (v) risks related to manufacturing complexity and supply chain for gene therapies; and (vi) risks of competition and rapidly evolving treatment landscape; as well as other 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 November 10, 2025, as well as any subsequent filings with the Securities and Exchange Commission. In addition, any forward-looking statement represents 4D Molecular Therapeutics' views only as of today and should not be relied upon as representing its views as of any subsequent date. 4D Molecular Therapeutics undertakes no obligation to update any forward-looking statements to reflect events or circumstances after the date of this press release, except as may be required by law. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements.
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