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What is the new medicine for edema? The latest FDA approval and emerging treatments

3 min read

In September 2025, the U.S. Food and Drug Administration (FDA) approved Enbumyst, a bumetanide nasal spray, for edema, marking a significant advancement in treating fluid overload. This new medicine for edema addresses key limitations of traditional diuretics and could change how conditions like heart and kidney disease are managed.

Quick Summary

The latest advancements in edema treatment include the FDA-approved Enbumyst nasal spray for heart and kidney conditions, alongside emerging therapies targeting specific causes like lymphedema and diabetic macular edema. Innovations focus on faster delivery and new mechanisms of action.

Key Points

  • Enbumyst Approval: The FDA approved Enbumyst, a bumetanide nasal spray, in September 2025 for treating edema associated with congestive heart failure, liver disease, and chronic kidney disease.

  • Rapid Outpatient Treatment: The nasal delivery of Enbumyst allows for faster and more reliable absorption than oral diuretics, enabling earlier outpatient intervention and potentially reducing hospital visits.

  • New DME Implant: Susvimo is an implantable device approved in February 2025 for diabetic macular edema (DME) that continuously delivers medication to reduce the need for frequent eye injections.

  • Targeting Lymphatic System: The investigational eLym System, a catheter-based device with FDA Breakthrough status, is being studied for its ability to assist the lymphatic system in draining fluid in acute heart failure patients.

  • Lymphedema Research: Clinical trials are underway to evaluate whether GLP-1 receptor agonists like Ozempic and Wegovy can treat lymphedema, while other research explores gene and regenerative therapies.

  • Personalized Approaches: The new developments reflect a broader trend in pharmacology toward more specialized and convenient delivery methods that address the specific needs of different types of edema.

In This Article

Edema, or fluid retention, is a common and often challenging medical condition affecting millions of people. It can be a symptom of underlying health issues such as congestive heart failure (CHF), chronic kidney disease (CKD), or liver disease. For decades, the standard of care has revolved around oral and intravenous (IV) diuretics, or “water pills,” which help the body excrete excess fluid. While effective, these treatments have limitations. Oral diuretics can be slow-acting, and their absorption can be unreliable in patients with significant fluid build-up. IV diuretics require hospital visits, increasing healthcare costs and burden. Recent advancements in pharmacology, however, are shifting this landscape toward more innovative, efficient, and patient-friendly solutions.

The New Approach: Enbumyst Nasal Spray

On September 15, 2025, the FDA approved Enbumyst (bumetanide nasal spray). This offers a rapid, non-invasive alternative to traditional diuretics for treating edema linked to congestive heart failure, liver disease, and chronic kidney disease. Bumetanide, a loop diuretic, increases sodium and water excretion in the kidneys. Its nasal delivery allows for faster absorption than oral tablets, providing quicker relief for fluid overload. This innovation could enable earlier outpatient treatment and potentially reduce hospital readmissions. Corstasis Therapeutics plans to launch Enbumyst in the US in the fourth quarter of 2025.

Other Emerging Therapies for Edema

Beyond general fluid retention, specific types of edema are also seeing significant therapeutic advancements:

Advancements for Diabetic Macular Edema (DME)

Susvimo (ranibizumab injection), an implantable device that continuously delivers medication directly to the eye, was approved in February 2025 for diabetic macular edema. This reduces the need for frequent eye injections, improving convenience.

Innovations for Heart Failure Fluid Overload

The eLym System (WhiteSwell), a novel catheter-based system, is being evaluated for acute decompensated heart failure (ADHF). This device assists the lymphatic system in draining excess fluid and has received FDA Breakthrough Device designation.

Research for Lymphedema

New research for lymphedema, which doesn't respond to standard diuretics, includes investigations into:

  • GLP-1 Agonists: Clinical trials are exploring if GLP-1 receptor agonists, such as Ozempic and Wegovy, can improve lymphedema symptoms, particularly in patients with obesity.
  • Gene and Regenerative Therapies: Research focuses on regenerating lymphatic vessels and inhibiting fibrosis to address the root cause.

Comparing Treatment Options for Edema

Feature Enbumyst Nasal Spray Standard Oral Diuretics (e.g., Furosemide) Susvimo Implant eLym System GLP-1 Agonists (e.g., Ozempic)
Administration Intranasal spray Oral tablet Ocular implant Catheter-based, minimally invasive Subcutaneous injection
Target Conditions CHF, liver disease, CKD-related edema Broad range of edema causes Diabetic Macular Edema (DME) Acute Decompensated Heart Failure (ADHF) Lymphedema (under investigation)
Primary Advantage Rapid, outpatient-friendly absorption Established, widely used, low cost Continuous delivery, reduces injection frequency Assists lymphatic drainage for severe cases Potential to address underlying metabolic factors
Key Limitation Not yet widely available (expected late 2025) Slower absorption, less reliable in some cases Specific to DME Investigational, not yet FDA-approved Investigational for lymphedema, not yet approved

Conclusion: A Shift Toward Specialized and Efficient Care

The treatment of edema is becoming more specialized and efficient. The FDA approval of Enbumyst nasal spray highlights a move towards convenient and rapid-acting drug delivery, potentially reducing healthcare costs. Simultaneously, targeted therapies for specific conditions like the Susvimo implant for DME and investigational treatments for lymphedema and heart failure fluid overload demonstrate a focus on addressing underlying disease mechanisms. These advancements offer the promise of more personalized and effective care for the millions affected by edema. Patients should consult their healthcare provider to discuss the most appropriate treatment options. For general information on edema, resources like the Mayo Clinic can be helpful.

Frequently Asked Questions

The most recent medication approved by the FDA for the treatment of general edema is Enbumyst (bumetanide nasal spray), which received approval on September 15, 2025.

Enbumyst is absorbed through the nasal passages directly into the bloodstream, bypassing the digestive system. This allows it to reach therapeutic levels more quickly and reliably than oral diuretics, whose absorption can be hindered by gastrointestinal issues.

No, Enbumyst is specifically approved for edema associated with congestive heart failure, liver disease, and chronic kidney disease. It is not indicated for other forms of edema, such as lymphedema.

Susvimo is an implantable device approved in February 2025 that continuously delivers the medication ranibizumab into the eye. It is used to treat diabetic macular edema (DME), a specific type of swelling in the macula caused by diabetes.

While anecdotal reports suggest improvement, clinical trials are still underway to determine the efficacy of GLP-1 agonists (e.g., Ozempic, Wegovy) in treating lymphedema. There is no FDA-approved medication for lymphedema at this time.

The eLym System is an investigational, minimally invasive catheter-based device designed to assist the lymphatic system in draining excess fluid in patients with acute decompensated heart failure (ADHF), potentially reducing rehospitalizations.

Corstasis Therapeutics has indicated that Enbumyst is expected to be launched in the US during the fourth quarter of 2025.

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Medical Disclaimer

This content is for informational purposes only and should not replace professional medical advice.