Boehringer Ingelheim Limited

Boehringer Ingelheim initiates Phase II study of BI 1815368, a potential first-in-class oral treatment for diabetic macular edema

Ingelheim, Germany, July 7, 2025 – Boehringer Ingelheim today announces the start of the THULITE Phase II clinical study (NCT06962839). It will investigate the efficacy, safety and tolerability of BI 1815368 as a potential oral treatment to improve vision in people with diabetic macular edema (DME).¹

DME is a leading cause of vision loss in people with diabetes. It affects more than 21 million people globally—impacting up to 10% of those living with diabetes.^2,3,4 Current treatments for DME require frequent visits to a retina specialist for eye injections, with each visit addressing only one eye at a time. This places considerable burden on patients and caregivers, especially when both eyes require treatment.^5,6

“DME is one of the most challenging complications of diabetes, and as vision worsens, people may lose their independence and reply more on loved ones,” said Dario Madani, CEO at PRO RETINA, members of which serve on Boehringer’s DME Clinical Program Steering Committee. “Patients and caregivers may have to balance work, family obligations and other diabetes complications, while managing their eye condition. We need treatment options that could reduce this burden.”

In DME, fluid leaks into the macula, the central part of the retina responsible for sharp vision needed for everyday tasks.³ BI 1815368 has the potential to treat and prevent fluid leakage by reducing the permeability of newly formed blood vessels. Unlike other treatments for DME, it is orally administered, offering the potential for at-home treatment and simultaneously addressing both eyes with, or at risk of DME.

“An oral therapy for DME could represent a major step forward in its management,” said Charles C. Wykoff, M.D., Ph.D., Principal Investigator of the trial, Director of Research, Retina Consultants of Texas and Chair of Research, Retina Consultants of America. “A safe and effective systemic therapy would offer an important alternative to repeated intravitreal injections; it could enable more consistent initiation of care earlier in the disease process, improve treatment adherence and optimize quality of life for patients.”

“At Boehringer Ingelheim, we are working towards a future where earlier intervention leads to long-term outcomes that prevent vision loss. One way we aim to achieve this is by developing oral treatments, which offer patients the ability to be more in control of their condition,” shared Dr. Patrick Bussfeld, Global Head of Medicine, Eye Health at Boehringer Ingelheim. “By targeting the disease pathway systemically, we also have the potential to prevent DME in one eye while the other is being treated.” 

BI 1815368 is the fourth investigational compound from Boehringer Ingelheim’s Eye Health portfolio to advance into Phase II clinical trials.^7,8 It is part of Boehringer’s broader clinical program targeting diabetic retinal disease, which also includes BI 764524, a Sema3A antibody being studied in the CRIMSON Phase II trial (NCT06321302) for diabetic retinopathy.

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).

1. 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.
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   3. Abramoff, MD, Fort PE, Han IC, et al. Investigative Ophthalmology & Visual Science. 2018;59:519-27.
   4. 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.