VEGF Trap-Eye, used for the treatment of the neovascular form of age-related macular degeneration (wet AMD), a condition that can lead to blindness, has been approved by a 10 to 0 FDA Panel vote. The treatment is approved for administration every other month at a dose of 2 milligrams, the panel recommended, which gives it an edge over rival Lucentis which needs to be used monthly.
VEFG Trap-Eye has the proposed brand name Eylea.
VEGF Trap-Eye is made by Regeneron Pharmaceuticals, Inc. Regeneron's shares were halted on Nasdaq, pending the results of the vote.
The unanimous vote by the Dermatologic and Ophthalmic Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) is not binding. The FDA is expected to make the final ruling on August 20th. However, the FDA nearly always goes along with the Committee's (Panel's) recommendations.
A BLA (Biologics License Application) was submitted by Regeneron in February 2011. It received a Priority Review designation, making the target date for an FDA decision August 20th, 2011.
FDA panel member Lynn Drake, a doctor at Massachusetts General Hospital, said:
"I think that the data suggests that this is an effective treatment and it's clearly needed. Anyone that's dealt with patients with this disease knows how devastating it can be."
George D. Yancopoulos, M.D., Ph.D., President of Regeneron Research Laboratories, said:
"The positive recommendation by the advisory committee is an important step toward providing wet AMD patients with a new treatment option that could potentially reduce the burden that exists with current therapies. We look forward to continuing to work with the FDA as it completes its evaluation of the Eylea BLA."
Regeneron said that lengthening the intervals between treatments will impact greatly on the patient's quality of life. There would also be fewer side effects. The drug is injected straight into the patient's eye by a doctor.
Jeffrey Heier, professor of ophthalmology at Tufts University and Harvard medical schools, who gave the Regeneron presentation, said:
"Monthly treatment leads to significant burden on patients, their caretakers and the healthcare system."
The eight-weekly Eylea injections were demonstrated to be as safe and effective as four-weekly Lucentis injections, according to Regeneron studies. Both medications stop the progression of wet age-realted macular degeneration, as well as improving patient's vision. 1.5 million Americans have lost their eyesight because of this condition.
Bayer HealthCare will market Eylea outside the USA, while Regeneron maintains exclusive rights within the United States.
Macular DegenerationMacular degeneration leads to the gradual loss of central vision. The patient finds it more difficult to see things that are directly in front. This affects reading, writing, recognizing faces, as well as driving. The macula is an oval shaped yellow spot close to the center of the retina in the eye. Macular degeneration, which causes damage to the retina, usually affects older individuals.
Macular degeneration is the largest cause of partial vision loss among people aged 50+ years. In most cases there is enough peripheral vision for the individual to walk about and carry on with daily activities.
Dry macular degeneration - there is no treatment, development is gradual. Patients can be taught how to cope with it.
Wet macular degeneration - develops more rapidly. The patient needs treatment as soon as symptoms appear. This is a more serious form of macular degeneration.
When patients develop symptoms over the age of 50, the condition is known as age-related AMD.
The following factors can contribute to a higher AMD risk: hypertension (high blood pressure), obesity, high cholesterol, high saturated fat intake, exposure to high-energy visible light, regular smoking, Caucasians have a higher risk.
Written by Christian Nordqvist