Ashvattha Therapeutics Announces Presentations Highlighting Mechanism of Action 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, IL-6, and IL-1β expression.

MGB, delivered via subcutaneous (subQ) administration, reduces inflammation and VEGF expression leading to inhibition of retinal fluid production in nAMD and DME patients after a single dose.

This clinical study showed stabilization of fluid and vision 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.

REDWOOD CITY, Calif.--(BUSINESS WIRE)--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, announced presentations at the Association for Research in Vision and Ophthalmology (ARVO) highlighting the clinical trial results of migaldendranib (MGB) for the treatment of diabetic macular edema (DME) and neovascular age-related macular degeneration (nAMD) and the novel mechanism of action of reducing VEGF, IL-6, and IL-1β expression.

Ashvattha has completed a two stage Phase 2 trial with positive topline results reported from the chronic MGB treatment stage of the study reported previously. The first stage of the study evaluated the mechanism of action of MGB after a single subcutaneous (subQ) dose of MGB administered after washout of intravitreal (IVT) aflibercept dose (return of retinal fluid to baseline). This multicenter, single ascending dose stage of the Phase 2 clinical trial evaluated the safety and mechanism of action of subcutaneous MGB, an investigational hydroxyl dendrimer covalently linked to a VEGF receptor tyrosine kinase inhibitor, designed to normalize VEGF expression in activated macrophages and microglia, and hypoxic retinal pigment epithelial cells. MGB also normalizes IL-6 and IL-1β expression in activated macrophages demonstrating an anti-inflammatory effect. Previously anti-VEGF treated DME and nAMD patients were enrolled. After a single IVT aflibercept dose in the study eye, patients were observed until retinal fluid returned to their baseline and then received a single subQ MGB dose to evaluate the potential to inhibit fluid production and maintain visual acuity. 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:

• MGB localization and activity in the retina as evidenced by stable central subfield thickness (CST) and best-corrected visual acuity (BCVA).
• Stable CST for ≥ 4 weeks all participants receiving 1.0 or 2.0 mg/kg subQ MGB without requiring supplemental IVT.
• 4 of 9 participants maintained stable CST for ≥ 8 weeks, and 1 participant maintained stable CST until end of study at 12 weeks (16 & 24 weeks after the single IVT aflibercept, respectively).
• BCVA was generally stable out to 12 weeks in all participants.
• SubQ MGB was safe and well tolerated with no treatment-related systemic or ocular serious adverse events (SAEs) and two participants had mild MGB-related injection site reactions reported.

"These Phase 2 results demonstrate the potential of subcutaneous MGB to inhibit fluid production and maintain best corrected visual acuity in patients with retinal vascular diseases and the possibility of a safe at-home administration," said Susan Schneider, MD, Acting Chief Medical Officer of Ashvattha Therapeutics. “The ability to normalize VEGF and pro-inflammatory cytokine (IL-6 and IL-1β) expression from systemic administration provides a novel approach to treating retinal vascular diseases. Monthly at-home subcutaneous administration of MGB could meaningfully reduce the burden of care for patients with DME and nAMD, conditions that are chronic and typically bilateral.”

Unlike current anti-VEGF therapies that require repeated intravitreal injections directly into each affected eye, subcutaneously administered MGB provides a differentiated mechanism of action by crossing the blood-retinal barrier in regions of inflammation and selectively normalizing VEGF expression in activated macrophages and microglia, and hypoxic retinal pigment epithelial cells. The anti-inflammatory properties of MGB may also be beneficial in reducing retinal inflammation and edema. By reducing VEGF expression rather than blocking VEGF signaling, MGB reduces the need for anti-VEGF intravitreal injections, which must be given in the physician’s office, and should potentially improve patient compliance by a safe, at home, monthly administered product.

“We are focused on diabetic eye diseases for MGB because many of these patients do not visit retinal ophthalmologists due to fear of chronic IVT injections, and approximately half of the patients on IVT treatment drop out after two years due to the heavy treatment burden,” said George Montgomery, Chairman of Ashvattha Therapeutics. “Our third-party market research indicates that MGB will be able to grow the multi-billion dollar market for diabetic eye disease treatment and increase patient flow and retention in retinal ophthalmology practices. We look forward to initiating our Phase 2b/3 trial in DME patients agreed upon with FDA later this year.”

Presentations:

Meeting: Eyecelerator
Presentation Time/Location: 2:23 pm, May 1, 2026 / Room 403, Colorado Convention Center
Presenter: Susan Schneider, MD
Title: Ashvattha Therapeutics, Inc.

Meeting: ARVO
Session: Diabetic Eye Disease III
Presentation Time/Location: 4:45 pm, May 5, 2026 / Bluebird Ballroom 1B, Colorado Convention Center
Presenter: Jeffrey L Cleland, PhD
Title: Subcutaneous migaldendranib, a novel first-in-class nanomedicine for 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.