Sydney, Australia: Thursday 24 June 2004. Australian eyecare company Regenera (ASX:RGA ) today signed a memorandum of understanding (MOU) with the Singapore Eye Research Institute (SERI), the national research institute of ophthalmology in Singapore, for cooperation on planned clinical trials of Visagen. The trials will begin in September 2004.
Specifically, Regenera and SERI have agreed to cooperate on clinical trials of the steroid triamcinolone acetonide (TA), the active component of Regenera’s Visagen™ product under development for the treatment of diseases of the back of the eye.
Included in the terms of the arrangement is the provision by Regenera of assistance in the preparation of the trial protocol, to ensure compliance with best practices specified by the US Food and Drug Administration.
Visagen’s key active ingredient is the synthetic steroid TA is already widely used “off-label” by ophthalmologists in the US, where the Regenera Group holds patent rights.
“We welcome the opportunity to work with a leading eye research institute such as SERI in taking Visagen to the stage of clinical trials of its effectiveness in treating inflammatory diseases of the eye, which are increasingly prevalent in our ageing society,” said chairman of Regenera, Tony Fitzgerald.
About Regenera
Regenera operates in the area of ophthalmology and has developed a treatment specifically for diseases of the back of the eye such as age-related macular degeneration (AMD) and diabetes-related (D-R) eye diseases.The Company listed on the Australian Stock Exchange on 16 June, having raised more than AUD$10 million in an Initial Public Offering which was oversubscribed by $2 million.
Visagen™, Regenera’s main product, is under development for the treatment of AMD and D-R eye diseases. It is a proprietary formulation of the synthetic steroid, triamcinolone acetonide (TA), a proven treatment of AMD. Recent clinical studies have demonstrated the effectiveness of TA in treating these diseases either alone or in conjunction with other treatments.
About the Singapore Eye Research Institute
Singapore Eye Research Institute (SERI) is the national research institute of ophthalmology in Singapore, funded by the National Medical Research Council. SERI is dedicated to performing vision research with local institutions as well as major eye centres and research institutes throughout the world. In the relatively short time since its inception in 1997, SERI has established a high profile as a leading centre in South Asia for eye and visual science research. In 2003, SERI was privileged to be appointed as a National University of Singapore affiliated institute. With its close integration of clinical, basic science and epidemiological research, SERI is a leading eye research centre in South East Asia.
About Age-related Macular Degeneration (AMD) and Diabetes Related Eye Diseases (DR)
Macular degeneration covers diseases that cause progressive loss of central vision, leaving only side vision intact. The most common form, AMD, is associated with ageing, affecting people over 50 years of age.
In Australia, an estimated 800,000 people suffer from macular degeneration, with 14% of those showing severe visual loss in one or both eyes. It is estimated that more than 15 million people in the US have the condition. Concurrently, the incidences of AMD and DR diseases are growing rapidly.
Dr William Ardrey
Chief Executive Officer
Regenera Limited
(08) 9389 5933
