Ashvattha Therapeutics Names Robert J. Dempsey Interim CEO After Achieving Positive Phase 2 Data And FDA Guidance On Next Pivotal Study

Ashvattha Therapeutics, a clinical-stage biotechnology company developing nanomedicine-based therapeutics that can cross the blood-retinal barrier and selectively target inflamed retinal cells, has announced the appointment of Robert J. Dempsey as Interim Chief Executive Officer, effective immediately. Robert Dempsey brings over 20 years of extensive experience in ophthalmology, encompassing drug development, commercialization, and strategic transactions across both domestic and international markets. His leadership background positions Ashvattha to advance its lead candidate, migaldendranib, into pivotal clinical development and potential partnership or commercialization stages.

This leadership transition follows the recent presentation of positive topline results from Ashvattha’s 40-week Phase 2 clinical trial of migaldendranib, a subcutaneously administered investigational nanomedicine, in diabetic macular edema (DME) and neovascular age-related macular degeneration (nAMD) at EURETINA 2025. The study demonstrated that migaldendranib was safe and well-tolerated, with no treatment-related ocular or systemic serious adverse events. Importantly, the therapy showed strong efficacy, including significant reductions in the need for supplemental intravitreal anti-VEGF injections—an 83.4% (sixfold) reduction in nAMD patients and a 78.6% (4.7-fold) reduction in DME patients. Additionally, a bilateral treatment effect was observed in both the treated and fellow eyes, further supporting migaldendranib’s potential to transform treatment approaches in retinal diseases.

Building on these promising results, Ashvattha recently received positive feedback from the U.S. Food and Drug Administration (FDA) regarding its clinical development plan for migaldendranib. The FDA endorsed the company’s Phase 2b/3 trial design, including the primary efficacy endpoint, study timing, and overall development strategy. The agency also accepted Ashvattha’s plan to conduct two studies under a single protocol, providing a clear regulatory pathway and reducing development risk. This strong FDA alignment marks a major milestone for the company and validates the potential of migaldendranib to address significant unmet medical needs in DME and nAMD—conditions that affect millions of patients who currently depend on frequent intravitreal injections.

Commenting on the appointment, Jeffrey L. Cleland, Ph.D., co-founder and Chairman of Ashvattha Therapeutics, stated that the company has reached a critical stage in its growth as an ophthalmology-focused organization. He expressed confidence that Robert Dempsey’s leadership will be instrumental in guiding the company through its next phase of development and success, adding that he looks forward to supporting Dempsey’s efforts to build a leading ophthalmology business.

In response, Robert J. Dempsey said he was honored to join Ashvattha at such a pivotal time. He highlighted that the FDA’s alignment on the company’s Phase 2b/3 protocol, along with the strong Phase 2 clinical data, provides a solid foundation for advancing migaldendranib toward pivotal trials. Dempsey emphasized the significant potential of this differentiated subcutaneous therapy to reduce the treatment burden for patients with DME and nAMD, underscoring his excitement to lead the company through this next stage of growth.