Ashvattha Therapeutics announced interim Phase 2 trial results for its subcutaneous migaldendranib (MGB), a potential treatment for diabetic macular edema (DME) and wet age-related macular degeneration (wet-AMD). The data, presented at the MaculArt Meeting, showed MGB was safe and effective through 24 weeks, potentially offering a monthly at-home alternative to the current standard of care, intravitreal injections. This subQ injection approach aims to reduce treatment burden and improve patient comfort.
The shift to a monthly subcutaneous injection could dramatically alter the treatment landscape for DME and wet-AMD. Current treatments require patients to undergo frequent intravitreal injections, posing a significant burden and potentially impacting adherence. A less invasive, at-home treatment option could improve patients’ quality of life and lead to better management of these chronic conditions, potentially slowing disease progression and preserving vision.
In the 24-week interim analysis, DME patients experienced a +4.5 letter improvement in best corrected visual acuity (BCVA) and a -69.1 µm reduction in central subfield thickness (CST). Wet-AMD patients maintained stable BCVA and CST. Treatment burden was reduced by approximately 80% in both groups, with a notable reduction also observed in the patients’ untreated fellow eyes (approximately 75%). The most frequent side effect was mild, transient injection site reactions. The study employed a more conservative criteria for supplemental anti-VEGF injections, strengthening the observed efficacy of MGB.
These promising interim results suggest that MGB could significantly improve the treatment experience for patients with DME and wet-AMD. If the final Phase 2 results confirm these findings, MGB could represent a major advancement in the field, offering a more patient-centric and potentially more effective approach to managing these debilitating eye diseases. This could lead to increased market share for Ashvattha and a shift in the standard of care for these conditions.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
