Kurs & Likviditet
Beskrivning
| Land | Sverige |
|---|---|
| Lista | First North Stockholm |
| Sektor | Hälsovård |
| Industri | Bioteknik |
Redwood Pharma has received approval from an Austrian ethics committee for the start of a clinical trial of RP501. This application represents the first of two necessary approvals for the commencement of the clinical trial. The company will now submit the clinical trial application for national approval by the Austrian Federal Office for Safety in Health Care (BASG). This initiates Redwood Pharma's development efforts towards a CE-marking approval of RP501, the company's novel, first-line treatment for relief of dry eye disease (DED). A CE-marking approval will facilitate the future sale of RP501 as an over-the-counter product within Europe.
CEO Martin Vidaeus says: "First-line treatments for DED represent a large and growing market globally. Artificial tears generate over two billion dollars in annual sales. RP501, a thermogel solution, is the next generation of first-line treatments that can reduce the number of instillations per day and thus provide increased comfort for those seeking relief from their symptoms. We are now taking the next step in the development towards a CE-marking approval through our planned clinical study under the leadership of Professor Gerhard Garhöfer. The study aims to generate meaningful data for regulatory applications to primarily assess the safety and efficacy of RP501 (IntelliGel) in men and women with and without contact lenses. A total of 60 patients will be included in the study. After having now received ethics approval, we can soon submit our application for clinical trial to the Austrian Medicines Agency (BASG). As soon as formal approval has been obtained, Redwood Pharma and its partner, the Medical University of Vienna, will begin to include patients in the study. "