Boehringer Starts Phase 2 Trial of Oral Therapy for DME

Boehringer Ingelheim has announced the initiation of the THULITE phase II clinical study (NCT06962839), a trial designed to evaluate the efficacy, safety, and tolerability of BI 1815368, an investigational oral therapy for the treatment of diabetic macular edema (DME).

Aiming to Transform the Management of DME

DME is a leading cause of vision loss in people with diabetes, affecting more than 21 million individuals globally. Current treatments are limited to intravitreal injections administered by retina specialists, often requiring frequent clinic visits and typically addressing only one eye at a time.

BI 1815368 is designed to reduce the permeability of newly formed blood vessels, preventing fluid leakage into the macula caused by DME. Unlike current injection-based treatments, this oral approach could allow for at-home administration and the simultaneous treatment of both eyes, offering a potentially significant shift in disease management.

Expert Perspectives on a New Approach

“An oral therapy for DME could represent a major step forward in its management,” said Charles C. Wykoff, MD, PhD, principal investigator of the trial, Director of Research at Retina Consultants of Texas and Chair of Research at 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.”

Dario Madani, CEO at PRO RETINA, which has members serving on Boehringer’s DME Clinical Program Steering Committee, also emphasized the patient burden:

“DME is one of the most challenging complications of diabetes, and as vision worsens, people may lose their independence and rely more on loved ones. 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.”

Part of a Broader Commitment to Eye Health

BI 1815368 is the fourth investigational compound from Boehringer Ingelheim’s Eye Health portfolio to advance into a phase II clinical trial. The company’s broader program targeting diabetic retinal disease also includes BI 764524, currently being studied in the CRIMSON phase II trial (NCT06321302) for diabetic retinopathy.

Patrick Bussfeld, MD, PhD, Global Head of Medicine, Eye Health at Boehringer Ingelheim, highlighted the company’s long-term vision:

“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. By targeting the disease pathway systemically, we also have the potential to prevent DME in one eye while the other is being treated.”