Ocular Clinical Safety of the MET penetration enhancer platform and OC134 for severe allergic conjunctivitis

Ocular allergies are widespread, affecting up to a fifth (20 %) of the world's population. Most patients will be helped by current medication available in the pharmacy. However, about 25 % of the sufferers have a more severe and chronic form of the condition (moderate to severe allergic conjunctivitis, MSAC) and are not effectively treated with these medicines.

MSAC is a form of the disease which is debilitating and can be sight threatening. For these patients the only available type of therapy (corticosteroids) can only be used sparingly because of the side-effects which can ultimately lead to blindness. Therefore, there is a significant unmet medical need and an urgent necessity for the availability of safe, steroid-sparing treatment options.

OC134 is a first in class topical aqueous eye drop formulation powered by Nanomerics proprietary Molecular Envelope Technology (MET) platform to deliver a known non-steroid drug with activity in the condition. MET has a dual functionality because it acts as non-irritant permeation enhancer: it increases the drug concentration at the disease site while avoiding systemic spill over into the blood stream, making OC134 a precision medicine.

The compelling pre-clinical data show that OC134 results in more than a 5-10 fold increase of the drug levels in the target tissues of the eye when compared to traditional eye drops at the same strength. Another important property of the system is that these water-like eye drops do not cause irritation which is otherwise commonly observed. OC134 contains the world's first non-irritant ocular penetration enhancer.

It is now important to demonstrate that these advantages can be translated into patients. The project will complete the first in-human clinical trial (Phase I) of OC134 to confirm the safety of both the product and the MET platform. Completion of the project paves the way to progression of OC134 to becoming a marketed product tackling a high level of unmet medical need.

Furthermore, this project will unlock the potential of other MET enabled ocular products in our pipeline allowing us to target other pressing ocular conditions at minimal risk.