Clinical trial research on the treatment of sub-cutaneous (subQ) migaldendranib (MGB), sponsored by Ashvattha Therapeutics, has announced interim results from an ongoing Phase II study for the treatment of diabetic macular oedema (DME) and wet age-related macular degeneration (AMD). The results were presented at the MaculArt Meeting, June 29–July 1, 2025 in Paris, providing “a first-in-class subcutaneously administered candidate being developed for convenient, at-home monthly treatment of DME and wet AMD, aiming to reduce treatment burden while avoiding systemic side effects.” If approved by regulators, the treatment may provide a paradigm shift of medical care for patients by reducing the burden of intravitreal injections at clinical hospital or consultant offices.
Migaldendranib (MGB) is a potent anti-angiogenic nanomedicine (“dendranib”) that crosses the blood-retinal barrier and selectively targets activated microglia, macrophages and retinal pigment epithelial cells in the eye. If approved, the treatment may offer an at-home dosing option by a subcutaneous route of administration, rather than delivery via intravitreal injection. The sponsor’s study, entitled “ Subcutaneous Migaldendranib (MGB) for the Treatment of Neovascular Age-Related Macular Degenerations and Diabetic Macular Edema: Interim Results of Chronic Dosing Phase 2 Study”, showed promising safety and tolerability in both DME and wet AMD patients in the first 24 weeks of treatment.
Figure 1 [a] and [b]).Previously presented by Michael Singer, MD, a board-certified vitreoretinal specialist and director of clinical research at Medical Center Ophthalmology Associates in San Antonio, Texas, and clinical professor of ophthalmology at the University of Texas Health Science Center in San Antonio. Dr. Singer is principal investigator for Ashvattha’s Phase 2 clinical trial evaluating migaldendranib, and is on the company’s advisory board.
The summary results showed that wet AMD patients had a central subfield thickness (CST) and a stable mean best corrected visual acuity (BCVA) for 24 weeks, with 45.5µm and +3 letters, respectively, and a comparable 79.9% reduction in treatment burden. DME patients exhibited a decreased central subfield thickness (CST) of -69.1 µm and an increased BCVA of +4.5 letters, with an observed reduction in treatment burden by 80%. In addition, the sponsor noted that fellow eye results also showed substantial treatment burden reduction of approximately 75%, compared to pre-treatment, demonstrating the potential bilateral benefits of subcutaneous administration. Finally, safety findings included injection site reactions in 8.6% of injections administered, which were reported to be localized, transient and mostly mild. According to Dr. Singer, Principal Investigator of the trial, he commented that, “this medicine is a subcutaneous injection that will treat both eyes with a single shot, and presumably we do it at home. It’s a tyrosine kinase inhibitor (TKI) like other TKIs, that blocks other forms of vascular endothelial growth factor (VEGF). What’s interesting is that it’s cleared in the kidney, so there’s no systemic or liver toxicity. It’s uptake is only by the retinal pigment epithelial (RPE) cells and macrophages in actively inflammatory lesions. It’s retained in the cells for 30 days and then cleared from the body in 2 days.”