Ashvattha Therapeutics Announces Positive Topline 40-Week Phase 2 Results for Migaldendranib in Diabetic Macular Edema and Neovascular Age-Related Macular Degeneration

Migaldendranib (MGB) is a new class of targeted nanomedicine for the treatment of diabetic macular edema (DME) and neovascular age-related macular degeneration (nAMD) with a novel mechanism of action that normalizes VEGF expression.

End of study, 40-week results demonstrated that MGB, delivered via subcutaneous (subQ) administration, is safe and well-tolerated with no MGB treatment-related ocular or systemic serious adverse events.

This Phase 2 clinical study showed improvements in efficacy outcomes and a marked reduction in the need for supplemental intravitreal anti-VEGF injections in both study and fellow eyes of DME and nAMD participants.

MGB has the potential for safe at-home administration, exhibiting a bilateral treatment effect with a single monthly subQ administration that may be an alternative option to frequent in-office intravitreal injections.

Excerpt from the Press Release:

REDWOOD CITY, Calif., Sept. 04, 2025 (GLOBE NEWSWIRE) — Ashvattha Therapeutics (“Ashvattha”), a clinical-stage company developing a nanomedicine therapeutic that traverses the blood-retinal barrier in areas of inflammation selectively targeting activated cells in the retina, today announced positive topline end-of-study results from its Phase 2 study of migaldendranib (MGB) for the treatment of diabetic macular edema (DME) and neovascular age-related macular degeneration (nAMD) at the 25th European Society of Retina Specialists (EURETINA) Congress.

This multicenter, chronic dosing, 40-week Phase 2 clinical trial evaluated the safety and efficacy of subcutaneous MGB, an investigational VEGF receptor tyrosine kinase inhibitor covalently linked to a hydroxyl dendrimer, designed to shut down VEGF expression in activated macrophages and microglia, and hypoxic retinal pigment epithelial cells. Previously anti-VEGF treated DME and nAMD patients were enrolled. Responders to intravitreal (IVT) anti-VEGF were identified prior to entering the 40-week MGB treatment period. Criteria for supplemental anti-VEGF IVT while receiving subQ MGB during the study were pre-defined. The participants’ worse-seeing eye was designated as the study eye.

Key findings include:

• The annualized rate of IVT injections in all study eyes (DME and nAMD) decreased from 8.4 to 1.6 per year, or a 78.6% (4.7-fold) DME (n=8) and an 83.4% (6-fold) nAMD (n=14) reduction in the need for supplemental anti-VEGF versus pre-study IVT

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