A potential oral treatment to improve vision in people with diabetic macular oedema (DMO), which is currently treated with eye injections, has moved into a Phase 2 clinical study.
The THULITE Study (NCT06962839) will investigate the efficacy, safety, and tolerability of BI 1815368, according to a media release from German biopharmaceutical company Boehringer Ingelheim.1
DMO is a leading cause of vision loss in people with diabetes. In DMO, fluid leaks into the macula, the central part of the retina responsible for sharp vision needed for everyday tasks.
BI 1815368 has the potential to treat and prevent fluid leakage by reducing the permeability of newly formed blood vessels. Unlike other treatments for DMO, it is orally administered, offering the potential for at-home treatment and simultaneously addressing both eyes with, or at risk of DMO.
By targeting the disease pathway systemically, we also have the potential to prevent DMO in one eye while the other is being treated.
“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,” said 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 DMO 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.
Reference
- Boehringer Ingelheim, Boehringer Ingelheim initiates Phase II study of BI 1815368, a potential first-in-class oral treatment for diabetic macular edema (media release, 7 July 2025) available at: boehringer-ingelheim.com/science-innovation/human-health-innovation/phase-ii-start-oral-treatment-diabetic-macular-edema [accessed July 2025].
