4D Molecular starts Phase 3 trial for diabetic eye disease drug

Emeryville, California - 4D Molecular Therapeutics (NASDAQ:FDMT) has initiated its Phase 3 clinical trial, known as 4SIGHT, to assess the efficacy of 4D-150 in treating diabetic macular edema (DME). The multinational study will involve 514 patients who have not previously received treatment for DME. The trial will compare 4D-150 against aflibercept 2 mg, administered every eight weeks, in a randomized, double-masked format. Participants will initially receive five aflibercept loading doses.

The primary objective of the trial is to determine if 4D-150 is non-inferior to aflibercept in improving best corrected visual acuity at week 52. Other secondary endpoints include reduced treatment burden and improvement in diabetic retinopathy severity.

In parallel, the company has shared data from its SPECTRA clinical trial involving nine patients who received the Phase 3 dose. This data showed a mean improvement of 10.8 letters in visual acuity and a 176-micrometer reduction in central subfield thickness. The treatment was well-tolerated, with no instances of intraocular inflammation, serious adverse events, or progression to proliferative diabetic retinopathy.

Patients in the SPECTRA trial required an average of 5.2 supplemental injections over two years, compared to the projected 13 injections with on-label aflibercept treatment, indicating a 61% reduction in treatment burden.

DME impacts around one million individuals in the United States and is traditionally managed with intravitreal anti-VEGF agents given every 4-12 weeks. 4D-150 has garnered FDA Regenerative Medicine Advanced Therapy designation for DME. The company has secured alignment with the FDA and European Medicines Agency for potential regulatory filings based on data from the 4SIGHT trial, as well as from its SPECTRA and PRISM trials, and its 4FRONT wet AMD program.