Stockholm, 24 January 2023. Redwood Pharma AB (publ) announces that the company has completed further preparations for the scale-up of production of the company's medical technology product RP501, which is being developed as a treatment for dry eye. As part of the preparations, Redwood Pharma has invested in equipment at the company's manufacturing partner.
During 2022, Redwood Pharma has worked to optimize the process and produce a technical production batch of RP501. Once the new equipment has been installed at the contract manufacturer, the company can proceed with adapting the production process according to the international quality standard GMP (Good Manufacturing Practices) and scale up production in order to build up inventory of the product for the coming commercialization. In parallel, Redwood Pharma continues to prepare the regulatory documentation required to apply for CE marking, which is necessary to launch the product in Europe.
"At the end of 2022, we carried out a test batch with the optimized process for scaled-up production of RP501. Now we are taking another important step towards the commercial production of our product by ensuring that all production equipment is in place", states Martin Vidaeus, CEO of Redwood Pharma.
RP501 is being developed to be an effective non-prescription tear replacement agent for the temporary relief of dry eye, a condition that affects more than 300 million people worldwide. RP501 is based on IntelliGel - a patented and unique formulation that has the consistency of a drop of water when instilled into the eye, where it immediately transforms into a viscous, protective and lubricating film that remains over longer period of time.
The company is currently conducting a clinical trial of RP501 and the results are expected to be available in the first half of 2023.