Redwood Pharma receives approval from an Austrian ethics committee for start of a clinical trial of RP501
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. ”
For further information
Martin Vidaeus – CEO, Phone: +46 70-232 29 29
About Redwood Pharma
Redwood Pharma develops ophthalmic products for unmet medical needs through novel approaches. In providing commercial partners and their customers with effective medical solutions, the company currently has products in development to treat dry eye disease in different target patient populations. The RP101 program targets moderate-to-severe dry eye disease in postmenopausal women by delivering a low-dose estrogen therapy to the front of the eye. The RP501 program aims to treat milder forms of dry eye in a broader patient population including both men and women. For other potential drug substances and therapeutic areas, the Company can employ the IntelliGel drug delivery platform that enhances patient convenience by controlling dosing and potentially reducing the number of instillations per day and subsequent side-effects. Redwood Pharma leverages its strengths in early clinical development and aims to generate revenues through, among others, licensing agreements with companies that have capabilities to manufacture and sell medical products worldwide.
Redwood Pharma AB (publ) is listed on the Nasdaq First North Growth stock market (Ticker: REDW.ST, ISIN: SE008294789).
For more information visit: www.redwoodpharma.com