The VEGF Trap-Eye aflibercept solution for injection is a new fusion protein recently approved by the Ministry of Health Malaysia for the treatment of wet age-related macular degeneration (AMD), based on convincing evidence from two Phase III clinical studies (VIEW 1 & VIEW 2) that demonstrated its efficacy in maintaining visual acuity with less frequent injections compared to a current therapy when administered over a 52-week study period.
“Wet AMD is a silent epidemic of the ageing population. It is a progressive, chronic eye disease that is a leading cause of preventable blindness among the ageing population, yet awareness remains dangerously low,” said consultant ophthalmologist and vitreoretinal surgeon Dr Kenneth Fong Choong Sian.
AMD affects an estimated 30 to 50 million people worldwide and is the leading cause of severe vision loss in developed countries. Wet AMD is a late form of the disease, affecting approximately 1.3% of people over 50 globally.
The prevalence of late AMD in Asians is largely similar to that in Caucasians. Even though wet AMD accounts for only about 10% of all AMD cases, it is responsible for 90% of the severe vision loss associated with the disease.
“Far too many are unaware of wet AMD and its symptoms. This means that they delay seeking treatment, unaware that they could lose their sight within three months. Those with wet AMD often lose the ability to read and write and perform household tasks. They also may have difficulty recognising faces or objects. The disease may also hinder mobility and independence, drastically affecting their emotional well-being. Blindness, regardless of its cause, drastically reduces a person’s quality of life,” added Dr Fong.
AMD is the breakdown of the macula, the part of the eye that is responsible for sharp, central vision needed to perform activities such as reading small print and threading a needle. Symptoms of AMD include blurriness, image distortions, or dark blotchy spots in the central part of a person’s vision.
There are two forms of AMD – dry and wet.
Wet AMD occurs when abnormal blood vessels begin to grow under the macula, beneath the retina. These new blood vessels can leak blood or fluid, blurring and scarring a person’s central vision.
The longer these abnormal blood vessels grow and the more they leak, the greater the risk of losing central vision. Vision loss due to wet AMD occurs more rapidly and noticeably than dry AMD. The damage is also more severe and irreversible.
“Without treatment, many people diagnosed with wet AMD will be functionally blind in two years. This means that it is crucial for patients to be diagnosed and treated as early as possible, and for them to stay on treatment in order to prevent further loss of sight.
“There is currently no cure for wet AMD, but there are treatments that can help slow the disease, or even reverse vision loss,” said consultant ophthalmologist Dr Wong Jun Shyan.
Early treatment options for wet AMD include laser, which is used to destroy the fragile, leaky blood vessels growing in the back of the eye, and photodynamic therapy, a light-activated drug that is injected into the arm and travels through the blood stream, after which a light is then shone into the eye to activate the drug to destroy the fragile, leaky blood vessels.
In more recent years, wet AMD is treated with vascular endothelial growth factor (VEGF) inhibitors, an effective treatment that targets a family of proteins that stimulate growth of the leaky vessels in the eye.
Commenting that laser treatments and photodynamic therapy are no longer widely used, Dr Wong said: “VEGF inhibitor therapy revolutionised the treatment of wet AMD and is the most common therapy used today. However, early VEGF inhibitor therapies require monthly monitoring of the eye and can be burdensome for both patient and physician.
“A new treatment such as aflibercept (that is proven to be effective with a good safety profile) can provide a simple but real benefit to patients. After the three initial monthly doses, aflibercept is administered every two months, giving patients more time between the monitoring visits.”
“With it, patients suffering from wet AMD can benefit from the effectiveness of a VEGF inhibitor therapy and enjoy a better quality of life with less frequent monitoring visits and possibly fewer injections. It marks an important milestone in wet AMD treatment and further fuels our commitment to improve lives through science,” said Thomas Steffen, managing director of Bayer Co (Malaysia) Sdn Bhd.