Novozymes Biopharma announced that an ophthalmic solution made using its recombinant human albumin, has been approved for Phase I/II development by the FDA.
Designed by R-Tech Ueno, RU-101 ophthalmic solution is being trialled as a therapy for severe dry eye, for which no effective treatment is currently available. The recombinant human albumin is part of Novozymes Biopharma’s albumin range. Novozymes Biopharma has a strong reputation in the industry for helping customers in the safe and successful commercialization and approval of new products.
The prevalence of severe dry eye, where patients suffer from instability of the tear film, continues to increase. It is the most diagnosed of all ophthalmic disorders and estimates put the market at approximately 1.5 billion USD. The trials for RU-101 ophthalmic solution will move ahead in two stages, the first of which will assess safety using a placebo control, and allow confirmation of the maximum dose. The second stage will then use this maximum dose for 12 weeks to evaluate the safety and effectiveness of RU-101 ophthalmic solution.
Dermot Pearson, Marketing Director at Novozymes Biopharma said, “Novozymes is dedicated to supporting our customers in the drug development and testing stages, and in assisting with the optimisation of their pathways through regulatory approval procedures. We are therefore delighted that RU-101 ophthalmic solution has been approved for clinical testing.”
Novozymes Biopharma’s recombinant albumin is designed to provide quality performance benefits when included in drugs developed by our customers. It was selected as a key component of this novel therapy back in 2011, due to its proven high quality and enhanced safety profile. Animal-free, with an exceptional purity profile and convenient liquid format at room temperature, recombinant albumin delivers consistent levels of quality, leading to reduced lot testing and vendor auditing.
All Novozymes’ recombinant human albumins deliver stable, safe and regulatory compliant ingredients for drug delivery and formulation, and are compliant with the National Formulary (NF) rAlbumin human monograph published by the United States Pharmacopeia (USP).