BioZurface – New first-line therapy for Dry Eye Disease (DED) with a fast onset of action, relieving signs and symptoms in DED patients.

Dry Eye Disease (DED) is a multifactorial, chronical eye disease that cause ocular surface inflammation and impact activities as reading, computer use and driving. The World Health Organization (WHO) has addressed eye health issues (2018), and acknowledged DED as a condition that have painful symptoms with substantial effect on general and health-related quality of life (QoL). The prevalence of DED in Europe (up to 30%) escalate with the ageing population and new lifestyles. Female gender and older age increase the risk. DED is a cost for patients, the health care system and society. In Europe costs to society is €78 Bn a year. Horizon 2020 recognizes DED as a priority for funding, and European Dry Eye Network (EDEN) was funded through a Marie-Curie action (2014). There is today no cure for DED. Biozep AS is an innovative Norwegian biopharmaceutical company developing safe and effective drugs for patients with chronic eye diseases; such as DED. They have identified a lead compound, BIZ-101, based on its effects documented by convincing in vitro data. Their first prototype product, “BioZurface” contains BIZ-101 outperforms one of the global leading products Ikervis® in an animal model of DED and also has faster onset action. Biozep’s approach is to carry out preclinical and Phase I/IIa studies and work with pharmaceutical partners to navigate the regulatory process through to market approval. Clinical studies will start in 2020 followed by market launch in 2025 by their target customers - pharmaceutical companies in the field of ophthalmology. The DryEyeCure project will include WPs as Optimization of Product Formulation, Production of API, Production of IMP, Non Clinical Safety Studies and Preparations & Phase 1 Clinical Trial. The ophthalmic drug market is currently $27 Bn (CAGR 5.5%) and the DED market alone is forecasted to reach $ 6.2 Bn by 2030. The preliminary sales estimates is min. €970 Mn sale of BioZurface in 2030.