RP501 represents an extension into the medical technology arena for Redwood Pharma

Redwood Pharma extends its reach into the medical technology arena with the broadening of its development programs with the RP501 for dry eye treatment. With its roots in pharmaceutical development, RP501 is an extension into medical devices building upon the latest clinical data from the company. Redwood is now devising the best strategy to commercialize this new treatment initially in Europe.

Facts about the medical technology industry in Europe[1]

  • 33,000 medical technology companies in Europe
  • 95% are small and medium-sized companies (SME) (i.e. Redwood Pharma)
  • Most companies are found in Germany, Italy, the UK, France and Switzerland

Medical technologies are products, service or solutions used to save and improve people’s lives. There are 3 main categories of medical technologies:

  • Medical devices (MDs) are product, services or solutions that prevent, diagnose, monitor, treat and care for human beings by physical means.
  • In vitro diagnostics medical devices (IVDs) are non-invasive tests used on biological samples (for example blood, urine or tissues) to determine the status of a person’s health.
  • Digital health refers to tools and services that use information and communication technologies (ICTs) to improve prevention, diagnosis, treatment, monitoring and management of health and lifestyle.

RP501 will be considered a medical device; the Redwood team with help of regulatory experts is developing a regulatory strategy to enter the European market by first obtaining a CE marking. The CE marking on a product indicates that the manufacturer or importer of that product affirms its compliance with the relevant EU legislation and the product may be sold anywhere in the European Economic Area (EEA)[2].

In parallel, we are also exploring regulatory processes for entry into the US market.

RP501 – a differentiated therapy addressing a large market

RP501 has significant therapeutic  and commercial potential as a next-generation first-line therapy to treat the majority of DED sufferer, including males and females of all ages. The global market was valued at US$2.3 billion in 2019 and expected to grow to US$2.9 billion by 2030 (Source: Transparency Market Research 2020). Today, DED sufferers turn first to artificial tears (saline eye drops) to provide temporary relief.  

Regular eye drops are, however, quickly cleared from the front of the eye and need frequent reapplication, creating a need for products that stay longer on the eye and reduce the number of drops to provide daily relief.

RP501 (IntelliGel) was used as the vehicle (placebo control) in the RP101 Phase II clinical trial completed last year, and our data from the RP101 trial showed that twice daily administration of RP501 improved both symptoms and objective measures of DED, in post-menopausal women with severe disease. In this trial, RP501 demonstrated increased tear fluid production as measured by the Schirmer test. Likewise, it improved various symptoms including foreign body sensation and dryness. RP501, as an easy-to-apply alternative to artificial tears providing long-lasting relief with fewer instillations per day, may thus offer a convenient and differentiated solution to over 340 million people worldwide suffering from DED.

For further information

Martin Vidaeus – CEO, Phone: +46 70-232 29 29

Email: martin.vidaeus@redwoodpharma.com

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 is currently developing treatments for dry eye disease in various target patient populations. The RP101 program targets moderate-to-severe dry eye disease in post-menopausal 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 of all ages. 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

[1] Medtech Europe publication, June 2021: The European Medical Technology in figures 2021

[2] https://en.wikipedia.org/wiki/CE_marking

2021-12-16