This section highlights FDA-related milestones and regulatory updates for drugs developed by 4D Molecular Therapeutics (FDMT).
Over the past two years, 4D Molecular Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
4D-150, 4D-175, and 4D-710. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
4D-150 - FDA Regulatory Timeline and Events
4D-150 is a drug developed by 4D Molecular Therapeutics for the following indication: Intravitreal vector, R100, and a transgene payload that expresses both aflibercept and a VEGF-C inhibitory RNAi.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- 4D-150
- Announced Date:
- July 2, 2025
- Indication:
- Intravitreal vector, R100, and a transgene payload that expresses both aflibercept and a VEGF-C inhibitory RNAi.
Announcement
4D Molecular Therapeutics announced the acceleration of the 4D-150 4FRONT Phase 3 program in wet age-related macular degeneration (wet AMD).
AI Summary
4D Molecular Therapeutics announced an accelerated timeline for its 4D-150 4FRONT Phase 3 program aimed at treating wet age-related macular degeneration (wet AMD). The North American Phase 3 trial, known as 4FRONT-1, now expects to deliver 52‐week topline data in the first half of 2027—six months ahead of the previous schedule—thanks to enrollment and site activation exceeding initial projections. This acceleration demonstrates strong support from investigators and patients, highlighting the potential benefits of 4D-150’s multi-year treatment effect with a single injection.
In addition, the company initiated its global 4FRONT-2 trial ahead of schedule in June 2025. While both trials share a similar design, the second trial will enroll both newly diagnosed treatment-naïve patients and those who have recently received treatment. This focused approach marks an important step in 4D Molecular Therapeutics’ efforts to transform retinal disease treatment and reduce the treatment burden for patients with wet AMD.
Read Announcement- Drug:
- 4D-150
- Announced Date:
- May 1, 2025
- Indication:
- Intravitreal vector, R100, and a transgene payload that expresses both aflibercept and a VEGF-C inhibitory RNAi.
Announcement
4D Molecular Therapeutics announced that the U.S. Food and Drug Administration (FDA) has granted the Regenerative Medicine Advanced Therapy (RMAT) designation to 4D-150 for the treatment of diabetic macular edema (DME).
AI Summary
4D Molecular Therapeutics recently announced that the U.S. Food and Drug Administration (FDA) has granted its Regenerative Medicine Advanced Therapy (RMAT) designation to 4D-150 for treating diabetic macular edema (DME). This milestone recognizes the drug candidate’s promising early results in the ongoing 4D-150 SPECTRA DME study and its potential to address a significant unmet need among patients with DME—a common and vision-threatening complication of diabetes marked by retinal swelling. The RMAT designation, which facilitates an expedited development and review process, supports 4D Molecular Therapeutics’ plans to move 4D-150 into Phase 3 trials. The company hopes that 4D-150 will lead to sustained improvements in visual acuity while reducing the treatment burden, potentially offering a long-lasting solution compared to the frequent injections typically required for managing DME.
Read Announcement- Drug:
- 4D-150
- Announced Date:
- March 10, 2025
- Indication:
- Intravitreal vector, R100, and a transgene payload that expresses both aflibercept and a VEGF-C inhibitory RNAi.
Announcement
4D Molecular announced that the first patients have been enrolled across multiple sites in the 4FRONT-1 Phase 3 clinical trial evaluating 4D-150 for the treatment of wet age-related macular degeneration (wet AMD).
AI Summary
4D Molecular Therapeutics announced an important milestone as the first patients have been enrolled in the 4FRONT-1 Phase 3 clinical trial for 4D-150, a new treatment for wet age-related macular degeneration (wet AMD). The trial is being conducted at multiple sites in North America and uses a randomized, double-masked design to compare 4D-150 with the current standard treatment, aflibercept. The study will check if 4D-150 can provide similar improvement in visual acuity over 52 weeks while reducing the number of injections needed. According to the company’s CEO, this trial is a historic step that could offer multi-year relief from frequent, invasive eye injections, potentially preserving sight for millions suffering from wet AMD. This enrollment marks 4D Molecular’s transition to a Phase 3 company in its journey to improve treatment standards for retinal diseases.
Read Announcement- Drug:
- 4D-150
- Announced Date:
- February 28, 2025
- Indication:
- Intravitreal vector, R100, and a transgene payload that expresses both aflibercept and a VEGF-C inhibitory RNAi.
Announcement
4D Molecular outlined expected upcoming milestones.
AI Summary
4D Molecular Therapeutics recently outlined its upcoming milestones, setting the stage for several key clinical trials. The company is preparing to initiate two large Phase 3 studies for its lead product candidate, 4D-150, aimed at treating wet age-related macular degeneration. The 4FRONT-1 trial is planned to begin in March 2025, with the 4FRONT-2 trial scheduled for the third quarter of 2025. Topline 52-week data from both trials is expected to be released in the second half of 2027. In addition, for diabetic macular edema, a 52-week interim data update from the SPECTRA trial is on track for presentation at a scientific conference in the third quarter of 2025. The company is also advancing its pulmonology program with 4D-710 for cystic fibrosis, reflecting a robust pipeline aimed at reducing treatment burdens and improving patient outcomes.
Read Announcement- Drug:
- 4D-150
- Announced Date:
- February 8, 2025
- Indication:
- Intravitreal vector, R100, and a transgene payload that expresses both aflibercept and a VEGF-C inhibitory RNAi.
Announcement
4D Molecular Therapeutics announced positive initial interim 52-week data from the Phase 2b Population Extension cohort of the PRISM clinical trial evaluating 4D-150 in a broad wet age-related macular degeneration (wet AMD) patient population. Additional data were provided on the durability of aflibercept expression for up to two years.
AI Summary
4D Molecular Therapeutics announced positive 52‐week data from the Phase 2b Population Extension cohort of its PRISM clinical trial of 4D-150 in patients with wet age-related macular degeneration (wet AMD). The study showed that most patients needed little to no extra aflibercept injections over the year, which could greatly reduce treatment burden. These results indicate promising levels of vision improvement and retina stability, offering hope for a treatment that minimizes the need for frequent injections.
In addition, the company provided encouraging data on the durability of aflibercept expression, with consistent levels observed for up to two years. These findings suggest that 4D-150 has the potential to offer long-lasting benefits for patients, positioning it as a future backbone therapy for treating vascular retinal diseases.
Read Announcement- Drug:
- 4D-150
- Announced Date:
- January 29, 2025
- Estimated Event Date Range:
- February 8, 2025 - February 8, 2025
- Target Action Date:
- February 8, 2025
- Indication:
- Intravitreal vector, R100, and a transgene payload that expresses both aflibercept and a VEGF-C inhibitory RNAi.
Announcement
4D Molecular announced that the Company will present the initial interim 52-week data from the Phase 2b Population Extension cohort of the PRISM clinical trial evaluating 4D-150 in a broad wet age-related macular degeneration (wet AMD) patient population at Angiogenesis, Exudation, and Degeneration 2025 being held virtually on February 8, 2025.
AI Summary
4D Molecular announced that it will present initial interim 52-week data from the Phase 2b Population Extension cohort of its PRISM study. The trial is evaluating 4D-150 in a broad group of patients with wet age-related macular degeneration (wet AMD). The data presentation is scheduled for the virtual Angiogenesis, Exudation, and Degeneration 2025 event on Saturday, February 8, 2025, with Dr. Dante Pieramici, a principal investigator on the PRISM trial, leading the session.
The data includes findings from a subgroup of recently diagnosed patients, which closely resembles those enrolled in the upcoming Phase 3 4FRONT-1 and -2 trials. The presentation will provide important insights into the treatment’s durability and safety profile. Additionally, a webcast is planned for February 10, 2025, to further discuss and analyze these interim results.
Read Announcement - Drug:
- 4D-150
- Announced Date:
- January 10, 2025
- Indication:
- Intravitreal vector, R100, and a transgene payload that expresses both aflibercept and a VEGF-C inhibitory RNAi.
Announcement
4D Molecular Therapeutics announced positive topline interim data from Part 1 of the SPECTRA clinical trial evaluating 4D-150 in diabetic macular edema (DME) and alignment with the U.S. Food and Drug Administration (FDA) on registrational pathway for 4D-150 in DME.
AI Summary
4D Molecular Therapeutics announced positive topline interim results from Part 1 of the SPECTRA trial evaluating 4D-150 for diabetic macular edema (DME). The data showed that 4D-150 was well tolerated with no intraocular inflammation observed. One tested dose, 3E10 vg/eye, demonstrated strong clinical activity by achieving a sustained gain of +8.4 letters in visual acuity and a reduction of -194 µm in central subfield thickness through Week 32. Additionally, this dose significantly reduced the injection burden—by up to 86% compared to projected on-label aflibercept 2mg given every eight weeks. Importantly, the company has received alignment from the U.S. FDA on a registrational pathway for 4D-150 in DME, paving the way for a single Phase 3 clinical trial based on the data gathered from both the SPECTRA and PRISM trials.
Read Announcement- Drug:
- 4D-150
- Announced Date:
- December 16, 2024
- Indication:
- Intravitreal vector, R100, and a transgene payload that expresses both aflibercept and a VEGF-C inhibitory RNAi.
Announcement
4D Molecular announced the publication of landmark preclinical data demonstrating the potential of the Company's proprietary Therapeutic Vector Evolution (TVE) platform, intravitreal R100 vector and the R100-based genetic medicine 4D-150.
AI Summary
4D Molecular Therapeutics announced landmark preclinical findings showing the promise of its proprietary Therapeutic Vector Evolution (TVE) platform. The company’s intravitreal R100 vector demonstrated significantly improved human retinal cell transduction—up to a tenfold increase over the standard AAV2—in both in vitro experiments and in primate retinal cells following injection. This advancement highlights R100’s potential as a best-in-class vector for treating retinal diseases.
The preclinical data also revealed that the R100-based genetic medicine, 4D-150, was well tolerated in nonhuman primate models of wet age-related macular degeneration (wet AMD). Following intravitreal delivery, 4D-150 produced robust retinal expression of dual transgenes, leading to complete suppression of severe choroidal neovascularization lesions. These promising results support ongoing Phase 1/2 and upcoming Phase 3 clinical trials aimed at transforming treatment options for wet AMD and diabetic eye diseases.
Read Announcement- Drug:
- 4D-150
- Announced Date:
- September 18, 2024
- Indication:
- Intravitreal vector, R100, and a transgene payload that expresses both aflibercept and a VEGF-C inhibitory RNAi.
Announcement
4D Molecular Therapeutics announced data showing continued robust and durable clinical activity, based on longest interim follow-up data from the Phase 1/2 PRISM clinical trial, and 4FRONT Phase 3 study design, which will be presented at its 4D-150 Wet AMD Development Day.
AI Summary
4D Molecular Therapeutics announced that its investigational 4D-150 treatment for wet age-related macular degeneration (AMD) has shown robust and durable clinical activity based on the longest interim follow-up from its Phase 1/2 PRISM trial. The data revealed significant treatment burden reduction, with around 70% of patients in a broad Phase 2 study remaining injection-free through 52 weeks, and an 83% overall reduction in annualized injections observed in the severe Phase 1/2a population. Safety results were promising, showing an intraocular inflammation profile similar to that of approved anti-VEGF agents. Additionally, the company unveiled its 4FRONT Phase 3 study design, aimed at maximizing the clinical, regulatory, and commercial success of 4D-150 in global markets. These key insights and further details will be presented at the upcoming 4D-150 Wet AMD Development Day webcast on September 18, 2024.
Read Announcement- Drug:
- 4D-150
- Announced Date:
- August 27, 2024
- Estimated Event Date Range:
- September 18, 2024 - September 18, 2024
- Target Action Date:
- September 18, 2024
- Indication:
- Intravitreal vector, R100, and a transgene payload that expresses both aflibercept and a VEGF-C inhibitory RNAi.
Announcement
4D Molecular Therapeutics announced that the Company will host a 4D-150 Wet AMD Development Day on September 18, 2024 at 4:15 p.m. ET.
AI Summary
4D Molecular Therapeutics has announced it will host a 4D-150 Wet AMD Development Day on September 18, 2024 at 4:15 p.m. ET. The event will focus on the development strategy for 4D-150 in treating wet age-related macular degeneration (wet AMD). Attendees can expect detailed presentations on the Phase 1/2 PRISM clinical trial, including discussions of the longest available interim follow-up data that highlight the candidate’s safety and biological activity. The webcast will feature live Q&A sessions with senior company leadership and a panel of key opinion leaders in retinal disease. This forum is designed to provide insights into the trial design, patient populations, and dosing strategies, helping to illuminate the strategic approach to optimizing the treatment regimen. The event aims to inform stakeholders about progress and future plans for 4D-150 in addressing wet AMD.
Read Announcement- Drug:
- 4D-150
- Announced Date:
- July 17, 2024
- Indication:
- Intravitreal vector, R100, and a transgene payload that expresses both aflibercept and a VEGF-C inhibitory RNAi.
Announcement
4D Molecular Therapeutics announced positive initial interim 24-week landmark data from the Population Extension cohort of the PRISM Phase 2 Clinical Trial, which evaluated intravitreal 4D-150 in a broad wet AMD patient population.
AI Summary
4D Molecular Therapeutics announced positive interim 24‑week data from the Population Extension cohort of its PRISM Phase 2 Clinical Trial. The study evaluated intravitreal 4D‑150 in a broad group of wet AMD patients. At the planned Phase 3 dose of 3E10 vg/eye, the treatment achieved an 89% reduction in the annualized injection rate, with 93% of patients receiving 0 or 1 injection and 77% remaining injection‑free through Week 24. In addition, patients at this dose experienced improvements in vision, with a mean increase of +4.2 letters from baseline and a dose response favoring the 3E10 vg/eye dose over the low dose (+5.7 letters). The study also demonstrated sustained anatomic control and a favorable safety profile, showing no significant inflammation. These results support 4D‑150’s potential to reduce the treatment burden and preserve vision for a wide range of wet AMD patients.
Read Announcement- Drug:
- 4D-150
- Announced Date:
- June 18, 2024
- Indication:
- Intravitreal vector, R100, and a transgene payload that expresses both aflibercept and a VEGF-C inhibitory RNAi.
Announcement
4D Molecular Therapeutics announced that the Company will present the initial interim 24-week landmark analysis from the Population Extension cohort of the PRISM Phase 2 Clinical Trial evaluating 4D-150 in a broad wet AMD patient population at the ASRS Annual Scientific Meeting being held in Stockholm, Sweden from July 17-20, 2024.
AI Summary
4D Molecular Therapeutics announced that it will present the initial interim 24-week landmark analysis from the Population Extension cohort of its PRISM Phase 2 Clinical Trial evaluating 4D-150 in a broad wet AMD patient population. The presentation will take place during the American Society of Retina Specialists (ASRS) Annual Scientific Meeting in Stockholm, Sweden, from July 17 to 20, 2024. The data include safety and clinical activity results from 45 patients, with details shared by Raj K. Maturi, M.D. at 8:49 a.m. CEST on July 17. Additionally, the company will host a webcast at 6:30 a.m. ET on the same day, where more details will be discussed and Q&A will be available with lead investigator Arshad M. Khanani, M.D. This analysis aims to provide further insights into the safety profile and potential clinical benefits of 4D-150 for patients affected by wet AMD.
Read Announcement- Drug:
- 4D-150
- Announced Date:
- June 8, 2024
- Indication:
- Wet AMD and diabetic macular edema
Announcement
- 4D Molecular Therapeutics today presented supplemental aflibercept injection-free subgroup analyses of the previously reported 24-week landmark results from the randomized Dose Expansion cohort from the Phase 2 PRISM clinical trial evaluating intravitreal 4D-150 in wet age-related macular degeneration (wet AMD) patients with severe disease activity and a high treatment burden.
AI Summary
4D Molecular Therapeutics recently presented supplemental analyses from the Phase 2 PRISM trial that focused on a subgroup of wet AMD patients with high disease severity and treatment burden. In these injection-free analyses, a single intravitreal dose of 4D-150 (3E10 vg/eye) maintained visual acuity levels that were equal to or higher than those achieved with the standard bimonthly aflibercept group over a 24-week period. Additionally, the 4D-150 treatment resulted in a sustained reduction and stabilization of the central subfield thickness, showing a mean CST change of –31 microns in favor of 4D-150 at Weeks 20 and 24. The findings provide further evidence of the therapy’s ability to improve retinal anatomy and stabilize vision without the need for supplemental anti-VEGF injections, reinforcing the positive topline results from the PRISM trial.
Read Announcement
4D-175 - FDA Regulatory Timeline and Events
4D-175 is a drug developed by 4D Molecular Therapeutics for the following indication: For the Treatment of Geographic Atrophy.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- 4D-175
- Announced Date:
- June 24, 2024
- Estimated Event Date Range:
- July 1, 2025 - December 31, 2025
- Target Action Date:
- 2025-H2
- Indication:
- For the Treatment of Geographic Atrophy
Announcement
4D Molecular Therapeutics announced that Enrollment for Phase 1 GAZE clinical trial is expected to begin in H2 2024
AI Summary
4D Molecular Therapeutics announced that enrollment for its Phase 1 GAZE clinical trial is expected to begin in the second half of 2024. The trial will assess 4D-175, a promising intravitreal genetic medicine designed to treat geographic atrophy (GA), a severe form of age-related macular degeneration. 4D-175 uses a low-dose R100 adeno-associated virus (AAV) vector to deliver a codon-optimized transgene that encodes a shortened version of human complement factor H (sCFH). This approach aims to provide durable treatment benefits with a single injection, potentially reducing the treatment burden for patients who currently undergo monthly or bimonthly injections. The Phase 1 study will focus on evaluating safety, tolerability, and transgene expression levels to determine the optimal dose for Phase 2 trials.
Read Announcement- Drug:
- 4D-175
- Announced Date:
- June 24, 2024
- Indication:
- For the Treatment of Geographic Atrophy
Announcement
4D Molecular Therapeutics announced U.S. Food and Drug Administration (FDA) clearance of the Investigational New Drug Application (IND) for 4D-175, an R100 vector-based intravitreal genetic medicine, for the treatment of patients with GA.
AI Summary
4D Molecular Therapeutics recently announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug Application (IND) for 4D-175. This novel treatment uses the company’s proprietary R100 vector to deliver a codon-optimized transgene encoding a shortened form of human complement factor H (sCFH). The therapy is designed for patients with geographic atrophy (GA), a severe, vision-threatening form of age-related macular degeneration (AMD).
The clearance paves the way for the Phase 1 GAZE clinical trial, which will assess the safety, tolerability, transgene expression, and biological activity of 4D-175 delivered via a single, low-dose intravitreal injection. This advancement offers hope for a durable treatment option that could decrease the current burden of frequent injections and improve long-term vision outcomes for patients with GA.
Read Announcement
4D-710 - FDA Regulatory Timeline and Events
4D-710 is a drug developed by 4D Molecular Therapeutics for the following indication: Cystic fibrosis lung disease.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- 4D-710
- Announced Date:
- June 6, 2024
- Indication:
- Cystic fibrosis lung disease
Announcement
4D Molecular Therapeutics announced positive interim clinical data from the 4D-710 Phase 1/2 AEROW clinical trial for the treatment of cystic fibrosis (CF) lung disease.
AI Summary
4D Molecular Therapeutics announced positive interim clinical data from the ongoing Phase 1/2 AEROW trial for 4D-710, a gene therapy treatment for cystic fibrosis (CF) lung disease. In the study, patients with mild to moderate lung function impairment showed meaningful improvements in lung function, as measured by ppFEV1, at the 12‐month follow-up. The treatment, delivered via aerosol at doses up to 1E15 vg, was well tolerated with no significant adverse events reported. Notably, robust and widespread expression of the CFTR transgene and protein was observed across lung samples, indicating the therapy’s potential to restore proper lung function in CF patients. The promising results have led the company to select the 1E15 vg dose for further development, with plans to begin enrollment for the Phase 2 Dose Expansion stage in the second half of 2024 and an interim update expected in mid-2025.
Read Announcement- Drug:
- 4D-710
- Announced Date:
- May 30, 2024
- Indication:
- Cystic fibrosis lung disease
Announcement
4D Molecular Therapeutics announced that interim data from the Phase 1/2 AEROW clinical trial evaluating aerosolized 4D-710 for treatment of cystic fibrosis lung disease will be presented at the 47th European Cystic Fibrosis Conference, taking place in Glasgow, UK.
AI Summary
4D Molecular Therapeutics announced that interim data from its Phase 1/2 AEROW trial evaluating aerosolized 4D-710 for cystic fibrosis lung disease will be presented at the 47th European Cystic Fibrosis Conference. The presentation, led by Dr. Jennifer L. Taylor-Cousar of National Jewish Health, will occur on Thursday, June 6, 2024, from 5:00 to 5:15 p.m. BST in Glasgow, UK. The data focuses on CFTR transgene expression in airway epithelial cells after treatment, offering insights into a new gene therapy approach for cystic fibrosis patients. Additionally, the company will host a webcast that same day at 8:00 a.m. ET, where more details about the interim results and program updates will be discussed. More information about the presentation is available on the 4D Molecular Therapeutics website.
Read Announcement
