4DMT Begins 4FRONT-1 Phase 3 Trial of 4D-150 in Wet AMD

12 March 2025
In EMERYVILLE, CA, USA, biotechnology firm 4D Molecular Therapeutics, recognized on the Nasdaq as FDMT, announced a significant milestone on March 10, 2025. The company, which is at the forefront of developing innovative treatments aimed at delivering enduring therapeutic solutions, has initiated patient enrollment for the 4FRONT-1 Phase 3 clinical trial. This trial is pivotal for evaluating 4D-150, a groundbreaking treatment targeting wet age-related macular degeneration (wet AMD).

The commencement of this trial marks a notable advancement for 4DMT, transitioning it into a Phase 3 company. According to David Kirn, M.D., Co-founder and CEO, 4D-150 is poised to address crucial unmet needs within the wet AMD patient community. The treatment promises to alleviate the strain of frequent eye injections and aims to preserve eyesight over extended periods. Dr. Kirn expressed optimism regarding the trial's design, the potential of 4D-150, and the positive clinical data so far, all of which he believes could lead to successful approval and widespread adoption in clinical practices.

4FRONT-1 is designed as a multicenter, randomized, double-masked study. It compares aflibercept 2 mg (administered every eight weeks) with intravitreal 4D-150 in treating wet AMD. The primary objective is to establish non-inferiority in changes from baseline in best corrected visual acuity over 52 weeks. A key secondary goal is to evaluate the reduction in treatment burden by comparing the number of aflibercept injections in the 4D-150 group against those in the comparator group. Participants in both study arms have the option to receive additional aflibercept injections as needed, with the trial enrolling treatment-naïve wet AMD patients across North America.

Looking ahead, 4DMT plans to launch a second Phase 3 trial, 4FRONT-2, which mirrors 4FRONT-1 in structure. This trial will expand globally, including patients who are either newly diagnosed or have prior treatment experience. The initiation of 4FRONT-2 is slated for the third quarter of 2025, with primary endpoint data from both trials anticipated in the latter half of 2027.

The implications of these trials are profound, given the current challenges faced by wet AMD patients. Dr. Fuad Makkouk, a principal investigator in the 4FRONT-1 trial, highlighted how the frequent intravitreal injections currently required present a significant quality-of-life burden on patients and their families. He emphasized the potential of 4D-150 to significantly improve patient experiences and outcomes.

Arshad M. Khanani, M.D., M.A., FASRS, and a principal investigator in the same trial, echoed this enthusiasm. Having previously participated in the PRISM Phase 1/2 study with 4D-150, Dr. Khanani noted its potential to alter the disease's trajectory and lessen the treatment burden. He expressed excitement about his involvement in 4FRONT-1, hopeful that 4D-150 could significantly impact patients' lives.

4D-150 represents a promising therapeutic approach, offering multi-year delivery of anti-VEGF treatments through a single, safe intravitreal injection. Developed using 4DMT's proprietary Therapeutic Vector Evolution platform, 4D-150 is engineered to alleviate the burdensome injection process associated with wet AMD and diabetic macular edema. The innovative design is intended to preserve vision while reducing treatment frequency.

Wet AMD is a prevalent condition projected to affect over four million people in major markets, including the U.S., EU, and Japan, within the next five years. It is characterized by the abnormal growth of blood vessels in the macula, leading to retinal swelling, bleeding, and scarring, which distort and diminish vision. This condition is driven by VEGF, and without intervention, it can progress to complete vision loss.

4DMT, through its pioneering research and development, continues to lead the charge in creating transformative treatments for retinal and other vascular diseases, with the promise of significantly improving patient care and therapeutic outcomes.

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