Ashvattha Therapeutics Reports Positive Phase 2 Results for Potential First-in-Class Treatment for DME and Wet AMD

Ashvattha Therapeutics announced positive topline results from its phase 2 study of migaldendranib (MGB) in diabetic macular edema (DME) and wet age-related macular degeneration (AMD) at the Euretina Congress.

MGB is an investigational VEGF receptor tyrosine kinase inhibitor covalently linked to a hydroxyl dendrimer, designed to cross the blood-retinal barrier selectively in inflamed areas and normalize VEGF expression in activated macrophages, microglia, and hypoxic retinal pigment epithelial cells. Unlike traditional anti-VEGF therapies requiring frequent intravitreal (IVT) injections, MGB is administered subcutaneously (subQ), with the potential for once-monthly, at-home dosing.

The multicenter, chronic dosing study enrolled patients with prior anti-VEGF exposure and identified IVT responders before initiating 40 weeks of MGB treatment in the worse-seeing study eye. Supplemental anti-VEGF IVT was permitted under predefined criteria.

Highlights include:

• Reduced Treatment Burden

  • In study eyes: Annualized IVT injections decreased from 8.4 to 1.6 per year – a 78.6% reduction in DME (n=8) and an 83.4% reduction in nAMD (n=14)

  • In fellow eyes: Annualized IVT injections decreased from 8.3 to 0.9 per year, an 89.1% reduction—demonstrating a bilateral therapeutic benefit

• Visual and Anatomic Outcomes

  • DME study eyes: +6.1 ETDRS letters in best-corrected visual acuity (BCVA) and –23.3 μm central subfield thickness (CST) at Week 40

  • nAMD study eyes: also showed improvements in both BCVA and CST

• Safety

  • SubQ MGB was well tolerated, with no treatment-related systemic or ocular serious adverse events

  • No clinically significant changes were observed in renal, hepatic, or cardiac parameters

“These phase 2 results demonstrate the potential of MGB to address one of the biggest challenges in retinal care today—the treatment burden associated with frequent in-office intravitreal injections,” said Susan Schneider, MD, Acting Chief Medical Officer, Ashvattha Therapeutics. “With the safe systemic and ocular outcomes seen to date, MGB offers a differentiated approach that could meaningfully reduce the burden of care for patients with DME and nAMD.”

“Over the 40-week duration of this trial, MGB was well tolerated, and we observed improvements in both vision and retinal anatomy, along with a significant reduction in the need for supplemental intravitreal injections,” added Arshad M. Khanani, MD, MA, FASRS, Sierra Eye Associates. “Delivering a bilateral therapeutic effect through a once-monthly subcutaneous injection represents a meaningful advancement for patients with these vision-threatening diseases.”