Boehringer Ingelheim Launches Phase II Trial of Oral BI 1815368 to Treat Diabetic Macular Edema

Boehringer Ingelheim Launches Phase II Trial of Oral BI 1815368 to Treat Diabetic Macular Edema

(IN BRIEF) Boehringer Ingelheim has initiated the THULITE Phase II trial (NCT06962839) to assess BI 1815368, a novel oral agent for diabetic macular edema (DME). Affecting more than 21 million people globally, DME is typically managed by frequent eye injections, a burdensome approach for patients and caregivers when both eyes require treatment. BI 1815368 aims to reduce vascular leakage in the macula, offering systemic, at-home administration that can address both eyes concurrently. The trial is led by Principal Investigator Charles C. Wykoff, M.D., Ph.D., and guided by input from patient advocates like Dario Madani of PRO RETINA. As the fourth compound in Boehringer’s Eye Health portfolio to reach Phase II—alongside BI 764524 in the CRIMSON diabetic retinopathy study—BI 1815368 underpins the company’s strategy of early, disease-modifying intervention in diabetic retinal conditions. Boehringer Ingelheim’s expertise in biopharmaceutical R&D, backed by over 130 years of innovation, furthers its mission to develop therapies that improve long-term outcomes and patient autonomy.

(PRESS RELEASE) INGELHEIM, 7-Jul-2025 — /EuropaWire/ — Boehringer Ingelheim has commenced the THULITE Phase II clinical trial (NCT06962839) to evaluate BI 1815368, an oral therapy designed to enhance vision in patients with diabetic macular edema (DME).1

A leading cause of sight impairment in people with diabetes, DME affects over 21 million individuals worldwide—up to 10 percent of the diabetic population.2–4 Present standard of care relies on repeated intravitreal injections, often requiring separate visits for each eye.5,6 This regimen places significant demands on patients and their caregivers, particularly when both eyes need treatment.

“DME is one of the most challenging complications of diabetes,” says Dario Madani, CEO of PRO RETINA and member of Boehringer’s DME Clinical Program Steering Committee. “As vision declines, patients lose independence and balance numerous health and life responsibilities. We urgently need treatments that ease this burden.”

BI 1815368 targets pathological leakage in the macula—the retina’s central zone responsible for detailed vision—by reducing the permeability of newly formed blood vessels. Administered orally, it offers the prospect of treating both eyes simultaneously from home, preventing fluid accumulation that leads to vision loss.

“Oral therapy for DME would be transformative,” notes Charles C. Wykoff, M.D., Ph.D., Principal Investigator of the trial and Director of Research at Retina Consultants of Texas. “A safe systemic option could replace frequent injections, enable earlier intervention, boost adherence, and substantially improve patients’ quality of life.”

“Early intervention is key to preventing irreversible vision damage,” explains Dr. Patrick Bussfeld, Global Head of Medicine, Eye Health at Boehringer Ingelheim. “By developing oral agents that address the underlying disease pathway, we empower patients to manage their condition and protect sight in both eyes.”

BI 1815368 is the fourth candidate from Boehringer’s Eye Health pipeline to enter Phase II studies, joining BI 764524 (a Sema3A antibody in the CRIMSON trial for diabetic retinopathy)7,8 as part of a comprehensive program against diabetic retinal diseases.

About BI 1815368

BI 1815368 is an investigational compound intended to ameliorate retinal vascular hyperpermeability, thus treating existing exudation and preventing future exudation. The compound was discovered and developed by Boehringer Ingelheim and is part of its research and development portfolio in retinal conditions.

About diabetic retinal disease

Diabetic retinal disease includes all diabetes-related changes in the retina (at the back of the eye), including harm to retinal blood vessels (diabetic retinopathy or DR), swelling in the retina (diabetic macular edema or DME), restriction of blood supply to the macula (diabetic macular ischemia or DMI), and damage to retinal nerve cells that help us see (diabetic retinal neuropathy or DRN).9

About diabetic macular edema (DME)

DME is a form of diabetic retinal disease characterized by the leakage of fluid (exudation) into the retina due to hyperpermeability of existing blood vessels in response to inflammatory processes driven by the underlying diabetes. Exudation in the fovea of the eye usually leads to significant vision loss that may become permanent and progressive.10

About Boehringer Ingelheim

Boehringer Ingelheim is a biopharmaceutical company active in both human and animal health. As one of the industry’s top investors in research and development, the company focuses on developing innovative therapies that can improve and extend lives in areas of high unmet medical need. Independent since its foundation in 1885, Boehringer takes a long-term perspective, embedding sustainability along the entire value chain. Our approximately 54,500 employees serve over 130 markets to build a healthier and more sustainable tomorrow. Learn more at www.boehringer-ingelheim.com.   

Boehringer Ingelheim’s Intended Audiences Notice

This press release is issued from our Corporate Headquarters in Ingelheim, Germany and is intended to provide information about our global business. Please be aware that information relating to the approval status and labels of approved products may vary from country to country, and a country-specific press release on this topic may have been issued in the countries where we do business.

References

1. ClinicalTrials.Gov. A Study to Test Whether BI 1815368 Helps People With an Eye Condition Called Diabetic Macular Edema. Available at: https://clinicaltrials.gov/study/NCT06962839. Accessed: June 2025.
2. James H B Im, Ya-Ping Jin, et al. Prevalence of diabetic macular edema based on optical coherence tomography in people with diabetes: A systematic review and meta-analysis. Survey of Ophthalmology. 2022;67:1244-51.
3. International Diabetes Federation. Clinical Practice Recommendations for Managing Diabetic Macular Edema. Available at: https://idf.org/media/uploads/2019/09/IDF-DME-CPR.pdf. Accessed June 2025.
4. Prevent Blindness. Diabetic Macular Edema (DME). Available at: https://preventblindness.org/diabetic-macular-edema-dme/. Accessed June 2025.
5. Watane A, Tabano D, Cox O, et al. Investigating nAMD and DME treatment burden on recipients and caregivers in the UK. Investigative Ophthalmology & Visual Science. 2023;64(4196).
6. Jampol LM, Glassman AR and Sun J. Evaluation and Care of Patients with Diabetic Retinopathy. The New England Journal of Medicine. 2020 Apr 23;382:1629-37.
7. Phase II start of oral treatment for Geographic Atrophy | Boehringer Ingelheim
8. Positive results Diabetic Macular Ischemia treatment | Boehringer Ingelheim
9. Abramoff, MD, Fort PE, Han IC, et al. Investigative Ophthalmology & Visual Science. 2018;59:519-27.
10. Sakini ASA, Hamid AK, Alkhuzai, ZA, et al. Diabetic macular edema (DME): dissecting pathogenesis, prognostication, diagnostic modalities along with current and futuristic therapeutic insights. International Journal of Retina and Vitreous. 2024;10:83.

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Dr Reinhard Malin
press@boehringer-ingelheim.com

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Phone +49 – 6132 – 77 0
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SOURCE: Boehringer Ingelheim