Key Takeaways
1. 4D-150 showed significant efficacy in treating DME, with a 9.7 letter improvement in best corrected visual acuity and a 174 micrometer reduction in central subfield thickness after 60 weeks.
2. Patients receiving the Phase 3 dose of 4D-150 needed 78% fewer supplementary injections compared to those on standard aflibercept treatment.
3. Four out of nine patients in the Phase 3 group were able to go without any injections, highlighting the therapy’s potential for reduced treatment burden.
4. 4D-150 was well tolerated with no signs of intraocular inflammation or other serious complications reported during the trial.
5. The therapy has the potential to transform DME treatment by improving adherence and providing lasting vision improvements.
4D Molecular Therapeutics (4DMT) has recently shared data from a clinical trial that lasted 60 weeks, focusing on its gene therapy known as 4D-150. This innovative therapy encodes aflibercept and a sequence that inhibits vascular endothelial growth factor C (VEGF-C). The active control in this study was aflibercept, which is an anti-VEGF medication.
Positive Efficacy Results
The findings demonstrate the effectiveness of 4D-150 in treating DME. Participants who got the Phase 3 dosage of 4D-150 experienced an improvement of 9.7 letters in best corrected visual acuity (BCVA) and a 174 micrometer decrease in central subfield thickness (CST). These outcomes suggest both visual and anatomical enhancements.
Reduced Injection Needs
Patients who received the Phase 3 dose of 4D-150 after three loading doses of aflibercept needed 78% fewer supplementary injections than those following the standard 2-milligram aflibercept treatment every 8 weeks. When comparing those on lower doses of 4D-150, patients on the Phase 3 dose fared better, needing 58% fewer supplemental injections. Out of nine patients in the Phase 3 group, four were able to go without injections, while only one out of 11 in the lower dose group achieved similar results.
These findings were presented by David Almeida during the 43rd Annual American Society of Retina Specialists (ASRS) Scientific Meeting.
Transformative Potential
According to David Almeida, “4D-150 has the potential to fundamentally transform the treatment of DME by reducing treatment burden with a product that has adherence by design, while providing meaningful, lasting vision improvement.”
The 4D-150 therapy was generally well accepted by the study participants. Throughout the trial, there were no signs of intraocular inflammation at any point, and none of the subjects required any changes to their topical corticosteroid treatment. There were no reports of hypotony, endophthalmitis, vasculitis, choroidal effusions, or retinal artery occlusion. Additionally, the average intraocular pressure stayed within normal ranges.
Source:
Link
Leave a Reply