(MENAFN- GlobeNewsWire - Nasdaq) FDA agrees with Phase 2b/3 clinical design, including primary endpoint and development approach, providing clear regulatory pathway to conduct two studies under single protocol

Dempsey brings proven track record of ophthalmology commercialization and will present company update at Eyecelerator ahead of American Academy of Ophthalmology Annual Meeting 2025

REDWOOD CITY, Calif., Oct. 14, 2025 (GLOBE NEWSWIRE) -- Ashvattha Therapeutics (“Ashvattha”), a clinical-stage company developing a nanomedicine therapeutic that traverses the blood-retinal barrier in areas of inflammation selectively targeting and reprogramming activated cells in the retina, today announced the appointment of Robert J. Dempsey as Interim CEO, effective immediately. Robert brings more than two decades of domestic and global experience in the ophthalmic space driving successful drug development, business transactions and commercialization to Ashvattha, positioning the company to advance its lead program through pivotal development and toward potential partnership or commercialization.

The appointment follows 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), presented at EURETINA 2025 in September. The data demonstrated that migaldendranib was safe and well-tolerated with no treatment-related ocular or systemic serious adverse events. The study showed improvements in efficacy outcomes and a marked reduction in the need for supplemental intravitreal anti-VEGF injections, with an 83.4% (6-fold) reduction in nAMD patients and a 78.6% reduction in DME patients. Notably, migaldendranib demonstrated a bilateral treatment effect in both study and fellow eyes, supporting advancement into pivotal development.

Building on these results, Ashvattha received strong support from the FDA for its clinical development program for migaldendranib – endorsing its roadmap to potential approval. Importantly, the FDA agreed with the company's Phase 2b/3 clinical design, including the primary efficacy endpoint, timing, and development approach, and has accepted Ashvattha's plan to conduct two studies under the same protocol. This guidance offers a clear regulatory path forward, de-risking key development milestones, and enabling advancement of pivotal development. This FDA interaction represents a meaningful value-inflection point and underscores the potential of Ashvattha's program to address significant unmet medical need in DME and nAMD, which affect millions of patients worldwide who currently require frequent intravitreal injections.

“Ashvattha has reached a critical inflection point as an ophthalmology-focused company. We are fortunate to bring on an experienced leader to guide the company through the next phase of growth,” said Jeffrey L. Cleland, PhD, co-founder and Chairman.“I look forward to supporting Bob's efforts to build a successful ophthalmology business.”

“I'm honored to be joining Ashvattha at this pivotal moment,” said Robert J. Dempsey, Interim CEO.“The FDA alignment on our Phase 2b/3 protocol, combined with the encouraging Phase 2 data, provides a strong foundation as we advance migaldendranib through pivotal development. Having led major transactions in ophthalmology, I see significant potential for this differentiated subcutaneous therapy that could meaningfully reduce treatment burden for patients with DME and nAMD.”

About Robert J. Dempsey

Robert brings more than 20 years of ophthalmology leadership across commercial, business development, medical affairs and venture-backed startups, with deep relationships across the ophthalmic ecosystem. Most recently, Robert served as Chief Executive Officer of AsclepiX Therapeutics following his CEO role at TearClear, accelerating business and commercial strategies that led to several value inflection points and positive FDA engagements.

At Shire (later acquired by Takeda), Robert served as Global Head of Ophthalmology where he built the ophthalmic franchise and led the launch of Xiidra, one of the most successful eyecare launches to date. He orchestrated one of only three ophthalmology transactions with >$1B upfront in the past two decades, with Xiidra transacting again four years later for He has also played key roles in early-stage venture capital fundraising and company building as a board member and advisor across multiple ophthalmology companies. His philanthropic time is spent as founder and board director of The Holland Foundation for Sight Restoration. Robert holds an MBA and a Bachelor of Science from Northeastern University in Boston, Massachusetts.

Robert will be presenting at Eyecelerator at the American Academy of Ophthalmology (AAO), where he will discuss Ashvattha's Phase 2 results, FDA alignment, and strategic vision. Details of the presentation are as follows:

Eyecelerator at American Academy of Ophthalmology 2025:

• Corporate Presentation
  Presenter: Robert Dempsey, Interim Chief Executive Officer of Ashvattha Therapeutics
  Date/Time: Thursday, October 16, 2025
  

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, microglia, and retinal pigment epithelial cells in the retina. Phase 2 clinical 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, 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:

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