The FDA has approved R-Tech Ueno's novel ophthalmic solution, developed using Novozymes Biopharma's recombinant human albumin, to enter into Phase I/II trials.
R-Tech is trialing RU-101 ophthalmic solution as a severe dry eye therapy.
Novozymes Biopharma marketing director Dermot Pearson 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."
First of the two-stage RU-101 studies will assess safety and confirm the maximum dose, which will then be evaluated for safety and effectiveness for a 12-week period in the second stage.
Novozymes' recombinant albumins are animal-free, pure and available in liquid form at room temperature.
The recombinant human albumins are designed to deliver stable, safe and regulatory compliant ingredients for drug delivery and formulation, and are compliant with the National Formulary rAlbumin human monograph published by the US Pharmacopeia, according to Novozymes.
Image: Ophthalmic solution from R-Tech Ueno made using Novozymes Biopharma's recombinant human albumin will enter clinical trials. Photo: Novozymes.
