Ashvattha Therapeutics (“Ashvattha”), a clinical-stage company developing an at-home subcutaneous (subQ) monthly treatment, announced presentations at HC Wainwright Conference, Ophthalmology Futures Retina Forum, and EURETINA, highlighting clinical trial results of migaldendranib (MGB) for the treatment of diabetic macular edema (DME) and neovascular age-related macular degeneration (nAMD).

Globally, approximately half (50%) of DME and nAMD patients discontinue treatment after 2-3 years due to the burden of frequent clinic visits often requiring 3-6 hours due to travel and the visit. The majority of these patients have bilateral disease, requiring an intravitreal (IVT) injection in each eye and often separate office visits for each procedure. Even a long-acting product would still require these patients to have a minimum of 4 office visits per year (one visit per eye, twice per year). In contrast, MGB is subcutaneously injected at-home once per month treating both eyes (bilateral treatment effect). Transitioning these patients to a treatment paradigm that includes subQ MGB, could allow them to retain vision with fewer office visits while still under the expert care and guidance of their retina specialist.

MGB Phase 2 Study Overview

Ashvattha has completed its two-stage Phase 2 trial of migaldendranib (MGB), a hydroxyl dendrimer conjugated to a VEGFR tyrosine kinase inhibitor delivered subcutaneously. Phase 2 data will be presented at the upcoming EURETINA annual meeting in Vienna with a focus on results that continue to demonstrate intended biological activity in the retina after subQ administration and positive efficacy outcomes. Positive topline results from the chronic-dosing stage were previously reported; results from the single-ascending-dose mechanism-of-action stage will be presented at EU Retina.

The Phase 2 clinical study enrolled DME and nAMD participants previously treated with anti-VEGF injections. In the first stage, participants received a single IVT aflibercept dose in the designated study eye (worse-seeing eye) and were observed until retinal fluid returned to baseline. They then received a single subQ dose of MGB in a dose-escalation design. Supplemental anti-VEGF IVT rescue could be administered according to pre-defined criteria.

Results

  • BCVA was generally stable in all participants through the primary endpoint at Week 12

  • Central subfield thickness (CST) remained stable for ≥4 weeks in participants receiving 1.0 or 2.0 mg/kg, with no required supplemental anti-VEGF IVT injections

  • SubQ MGB was safe and well tolerated with no reported treatment-related systemic or ocular serious adverse events (SAEs); mild injection site reactions occurred in two participants

A single systemic subQ dose of MGB demonstrated its localization and activity in the retina. Clinical outcomes support MGB’s dual anti-VEGF and anti-inflammatory mechanism, normalizing VEGF, IL-6, and IL-1β in activated macrophages, microglia, and hypoxic RPE. A bilateral treatment effect was seen. Phase 2 data from both stages of the study, support advancement into Phase 2b in DME.

“Ashvattha’s clinical trials to date have demonstrated MGB’s localization and activity in the eye, resulting in structural and functional benefits and a reduced need for intravitreal anti-VEGF,” said Susan Schneider, MD, Acting Chief Medical Officer of Ashvattha Therapeutics. “In these clinical trials, MGB was safe and well tolerated, potentially allowing at-home subQ administration and a bilateral treatment effect. We are excited about our Phase 2b/3 study in DME patients, currently planned for 2027.”

“We are focused in retaining patients who otherwise stop visiting their ophthalmologist. Diabetic patients are often working age and must take significant time off work to remain compliant with current therapies,” said George Montgomery, Chairman of Ashvattha Therapeutics. “Our global market research indicates approximately half of patients stop receiving treatment after 2-3 years, a market substantially larger than currently treated patients. By continuing to treat these discontinued patients, MGB will maintain their vision, and retain them in the clinical practice of retinal ophthalmologists. We look forward to initiating our Phase 2b/3 trial in DME patients agreed upon with FDA.”

Presentations:

Meeting: HC Wainwright Annual Conference, September 14-16, 2026

Presentation Time/Location: September 14, 2026, Virtual

Presenter: Jeffrey L Cleland, PhD

Meeting: Ophthalmology Futures Retina Forum, September 30, 2026

Presentation Time/Location: Imperial Riding School, Vienna

Presenter: Susan Schneider, MD

Title: Ashvattha Therapeutics, Inc. presentation and Retina Forum panel

Meeting: EURETINA, October 1-4, 2026

Session: e-Poster

Presenter: Prof. Paulo Eduardo Stanga, The Retina Clinic London Ophthalmic Institute

Abstract Number: RETINA26-1222

Abstract Title: Migaldendranib, a novel first-in-class hydroxyl dendrimer nanomedicine administered subcutaneously for the treatment of diabetic macular edema and neovascular age-related macular degeneration

About Migaldendranib

Migaldendranib (MGB) is a novel first-in-class nanomedicine in clinical development for the treatment of DME and nAMD. Administered subcutaneously, MGB has a differentiated mechanism of action that crosses the blood-retinal barrier in regions of inflammation and selectively normalizes VEGF expression in activated macrophages and microglia, and hypoxic retinal pigment epithelial cells in the retina. MGB also normalizes IL-6 and IL-1β expression in activated macrophages. Phase 2 clinical trial results demonstrate that subcutaneous MGB is safe and well-tolerated across multiple doses, with the potential for convenient once-monthly at-home administration that could significantly reduce intravitreal injection burden for patients with DME and nAMD, including those with bilateral disease.

About Ashvattha Therapeutics

Ashvattha Therapeutics is advancing a new class of clinical-stage nanomedicine therapeutics that traverse tissue barriers to selectively target and reprogram activated cells only in regions of inflammation. Our targeted nanomedicine approach seeks to redefine precision medicine, empowering a new standard of care in ophthalmology. Ashvattha Therapeutics was founded by Kannan Rangaramanujam, Sujatha Kannan, and Jeff Cleland and incubated by Natural Capital. For more information, visit: www.avttx.com

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