Singapore, 18 July 2022 – The Singapore Eye Research Institute (SERI) and Roche today announced Vabysmo® (faricimab) was approved for use by Singapore's Health Sciences Authority for the treatment of neovascular age-related macular degeneration (nAMD)[1] and diabetic macular edema (DME)[2] in June. Vabysmo was discovered by Roche scientists and is developed and manufactured by the company. The process was supported by SERI's research team, who gathered evidence required to facilitate clinical trials.
nAMD affects about 20 million people worldwide, and is the leading cause of vision loss in people above age 60. As the global population ages, nAMD will affect even more people. DME affects around 21 million people globally, and this number is also expected to grow as the prevalence of diabetes increases. When left untreated, DME is associated with blindness and decreased quality of life. There remains a significant unmet need for more effective, longer-lasting therapies for people with DME.
Vabysmo was developed with the expertise of the SERI research team over a span of 10 years. It is the first bispecific medicine for the eye. The medicine targets and inhibits two pathways – angiopoietin 2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A) – that are activated in retinal diseases which can lead to vision loss. By inhibiting both pathways, the medicine enables blood vessels to become more stable, and thereby reduces vessel leakage and inflammation in the eye.
"We are honoured to be a part of the development of Vabysmo in partnership with Roche. This is another exciting milestone for SERI, and we celebrate it because patients with nAMD and DME now have another option to help retain their vision," said Professor Gemmy Cheung, Head of the Retina Research Group at SERI and Medical Retina Department at Singapore National Eye Centre.
"Vision loss caused by retinal conditions can be physically, emotionally and economically devastating for people with nAMD and DME. Vabysmo represents a new approach that can help improve vision outcomes for longer periods and potentially reduce the burden of disease with fewer injections compared to with current available therapies," said Dr Sivabalan Sivanesan, Director of Medical & Regulatory Affairs at Roche Pharmaceuticals, Singapore. "We are proud that our partnership with SERI has brought this new option to patients and are committed to our continued collaboration to address the needs of people living with retinal conditions in Singapore."
SERI's forte in end-to-end clinical trials
Over the last 25 years, SERI has developed several therapeutics internally. One of its most notable successes is the low-dose atropine drug, MyopineTM, which aims to slow down the rapid progression of myopia in children, with minimal side effects. After a series of landmark clinical trials, it was clinically proven that 0.01% of atropine can slow down myopia by as much as 60% in young children, compared with untreated children. MyopineTM, unveiled in 2013, has since been licensed to companies in at least 12 countries in Asia and Europe, and is available for patients locally and overseas.
The drug development process usually takes around a decade; from the initial discovery stage, to pre-clinical development, three to four phases of clinical trials, and finally to approval from authorities. SERI is one of the few research institutions worldwide that has the capabilities and resources to see ophthalmic drug development from pre-clinical stage through to clinical trial phase (end-to-end), all under one roof.
"When it comes to handling clinical trials, its logistics and administrative requirements, SERI has a competitive edge over counterparts around the world. As an academic centre that enjoys close ties with a clinical centre, SERI performs these trials seamlessly and efficiently. This gives industry players a strong reason to work with our team when they are looking to manufacture ophthalmic drugs, a process where speed, accuracy and quality are big considerations," said Professor Jodhbir Mehta, Executive Director of SERI.
Efficacy of Vabysmo versus current standard of care
Four pivotal Phase III studies of faricimab were published across two papers in The Lancet earlier this year. In the four studies which recruited 3,000 patients, it was found that a significant proportion of patients treated with faricimab intravitreal injections up to every four months achieved results comparable to those treated with an existing drug every two months or monthly. By extending the time between treatments, it cuts down patients' number of visits for injections, and thereby potentially reduces their burden of treatment.
"nAMD and DME are leading causes of blindness and a focus of our research at SERI. Our multidisciplinary team leverages the expertise of scientists and clinicians, and brings together stakeholders including academia, hospitals and industry partners. Developing new therapies and diagnostics have been a key focus of our work. Our Translational Asian Age-related macular degeneration Programme (TAAP) has been boosted by a recent $24 million collaborative grant from the National Medical Research Council. Collaboration between academia with industry partners, such as SERI with Roche, is very important in expediting the bench-to-bedside translation," explained Prof Cheung. "AMD is a disease that requires highly personalised treatment. As such, the more treatment options there are available, the better it is for patients."
[1] Age-related macular degeneration is a condition that affects the part of the eye that provides sharp, central vision needed for activities like reading. Neovascular or "wet" AMD is an advanced form of the disease that can cause rapid and severe vision loss. It develops when new and abnormal blood vessels grow uncontrolled under the macula, causing swelling, bleeding and/or fibrosis.
[2] Diabetic macular edema is a vision-threatening complication of diabetic retinopathy. DME occurs when the damaged blood vessels leak into and cause swelling in the macula – the central area of the retina responsible for the sharp vision needed for activities like reading and driving.
