Why Is Eye Disease-Focused 4D Molecular Therapeutics Stock Shooting Higher Today?

4D Molecular Therapeutics FDMT shares are trading higher after the company released interim data from the Phase 2 PRISM clinical trial evaluating intravitreal 4D-150 in wet age-related macular degeneration (wet AMD) patients. 

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: None
• 97% (38 of 39 pts) completed the 20-week prophylactic topical corticosteroid taper on schedule
• Low dose: Single eye at week 16 had 1+ anterior mixed (pigmented & white blood) cells, resolved by next visit and completed prophylactic topical corticosteroid taper by week 26
•  All patients are currently off steroids.
• No 4D–150–related serious adverse events (SAEs) or study eye SAEs, with no hypotony, endophthalmitis, retinal vasculitis, choroidal effusions, or retinal artery occlusions, were observed.

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 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.

Photo by Amanda Dalbjörn on Unsplash