Data presented at the Angiogenesis, Exudation, and Degeneration 2024 Conference consisted of 24-week landmark results from the PRISM clinical trial’s randomized Phase 2 Dose Expansion cohort.

A single intravitreal dose of 4D-150 demonstrated favorable safety results through the data cutoff date (all ophthalmic exams through up to 48 weeks of follow-up):

No significant intraocular inflammation

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 and central subfield thickness were both stable vs. Regeneron Pharmaceuticals Inc.’s (NASDAQ:REGN) Eylea ( aflibercept).

4D-150 was well tolerated with a favorable safety profile when evaluated through up to 48 weeks of follow-up: no significant inflammation was observed (including no Grade ≥1+ inflammation in high-dose patients), and all patients remained off topical steroids.

The company plans to start the first Phase 3 study in the first quarter of 2025.

Safety results were maintained in all 15 patients treated to date (up to 104 weeks of follow-up) with no new inflammation or change in steroid status.

Price Action: FDMT shares are up 71.58% at $30.00 on the last check Monday.

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