4D Molecular: Positive Interim Data from Phase 2 Wet AMD Trial

 

• 51 wet AMD patients with severe disease activity (mean of 442 µm central subfield thickness & presence of retinal fluid) and high treatment burden (mean of 10 anti-VEGF injections in preceding 12 months) were randomized to high (3E10 vg/eye) or low (1E10 vg/eye) dose 4D-150 or aflibercept control regimen
• 4D-150 was well tolerated with a favorable safety profile when evaluated through up to 48 weeks of follow-up: no significant inflammation observed (including no Grade ≥1+ inflammation in high dose patients) and all patients remained off topical steroids
• High dose 4D-150 resulted in an 89% reduction in the annualized anti-VEGF injection rate; 84% of patients received 0 or 1 injection, and 63% were injection-free through 24 weeks; visual acuity & central subfield thickness were both stable vs. aflibercept
• Positive interim results enable rapid advancement towards pivotal development, with Phase 3 clinical trial initiation expected in Q1 2025
• Company to host webcast on Monday, February 5, 2024 at 8:00 a.m. ET

Corporate Webcast Details to Discuss the Results:

Title:	4D-150 Randomized Phase 2 Dose Expansion in Severe Disease Activity Wet AMD with High Treatment Burden: Interim Clinical Data & Program Update
Date/Time:	Monday, February 5, 2024 at 8:00 a.m. ET
Registration:	Link

An archived copy of the webcast will be available for up to one year by visiting the “Investors & Media” section of the 4DMT website at the following link: https://ir.4dmoleculartherapeutics.com/events.

https://www.globenewswire.com/news-release/2024/02/03/2823166/0/en/4DMT-Presents-Positive-Interim-Data-from-Randomized-Phase-2-PRISM-Clinical-Trial-of-Intravitreal-4D-150-Demonstrating-Favorable-Tolerability-Clinical-Activity-in-Wet-AMD.html