Boehringer Ingelheim has initiated the THULITE Phase II trial to evaluate the safety, tolerability and efficacy of BI 1815368, an oral treatment aimed at improving vision for individuals with diabetic macular oedema (DMO).
The study specifically targets adults aged 18 years and above who are affected by a subtype known as centre-involved DMO.
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It consists of two parts, where subjects are randomly assigned to receive either the investigational oral treatment or a placebo.
The first part involves two groups taking either BI 1815368 or placebo tablets, while the second part includes four groups with three receiving varying doses of BI 1815368 and one receiving a placebo.
Over approximately one year, subjects will be required to attend 16 times to the study site.
During these visits, healthcare professionals will monitor their vision, record any health issues, and capture images of the eye to track changes and assess the treatment’s functioning. The study has ten US locations.
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By GlobalDataDMO involves fluid leakage into the macula, which is crucial for sharp central vision.
Discovered and developed by the company, BI 1815368 aims to ameliorate retinal vascular hyperpermeability.
This compound represents the fourth candidate from the company’s Eye Health portfolio to progress into Phase II trials and is part of a wider clinical programme aimed at diabetic retinal diseases, including the Sema3A antibody BI 764524, currently in the CRIMSON Phase II trial for diabetic retinopathy.
Boehringer Ingelheim eye health’s global head of medicine Dr Patrick Bussfeld said: “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 diabetic macular oedema in one eye while the other is being treated.”
In April 2025, Boehringer’s drug candidate for human epidermal growth factor receptor 2 (HER2)-mutated non-small cell lung cancer (NSCLC) showed a durable response of more than 14 months while maintaining a manageable safety profile.
