Diabetic retinopathy (DR) is the leading cause of blindness in working age adults with high unmet medical need. There are no treatments for early-stage diabetic retinopathy which account for more than two thirds of total number of DR patients potentially requiring a therapeutic intervention. Current intravitreal treatments mainly target advanced, exudative diabetic retinopathy, when visual function is lost. New therapies in development are focused on intravitreal or oral applications, as topical therapies have shown previous limitations, using water as the delivery formulation.
Novaliq conducts a comprehensive R&D program with distinct and novel drug candidates with relevant mode-of-action in diabetic retinopathy assessing small & biomolecules, and NCEs with evidence of preclinical pharmacological effects on the pathophysiology of DR. The goal of the program is to maintain functional vision by treating diabetic retinopathy patients earlier, with a non-invasive, easily administered topical drug therapy. We therefore focus on novel pathways relevant to the non-proliferative stages of DR, such as vasodilative, anti-ischemic or neuroprotective, to halt progression to sight-threatening, proliferative, exudative diabetic retinopathy. A clear regulatory pathway with established clinical endpoints by the US FDA makes the development in diabetic retinopathy further attractive. Novaliq expects to complete the pre-IND enabling studies and targets a pre-IND meeting with the US FDA in 2025 for at least one API for a topical drug product for patients with non-proliferative diabetic retinopathy therapy.