In another stroke against macular degeneration, the Federal Drug Administration (FDA) has just approved a new drug for use by patients with a specific form of the condition, which is a leading cause of blindness in seniors. “Lucentis” (ranibizumab injection) is a monthly injectable that has been shown to help maintain vision in more than 90% of patients with a specific form of neovascular age-related macular degeneration (wet AMD), as shown by major Phase III studies.
Wet AMD is a retinal condition that is a major cause of blindness in people who are 55 and older. The retinal disease accounts for 10% of all AMD cases and is responsible for about 80% of vision loss associated with the condition.
So what causes wet AMD? Basically the growth of abnormal leaky blood vessels cause damage in the part of the eye that is responsible for central vision. This happens gradually and leads to the deterioration of the fine vision you need in order to do things such as driving, reading, or recognizing detailed objects.
The way that Lucentis works is that it blocks new blood vessel growth and leakiness. This helps slow down the disease’s progression, which could help prevent vision loss. It’s not painful and it occurs over a period of months to years.
In the United States, there are 1.7 million people who have the advanced form of AMD, according to the National Eye Institute. This number could grow to 2.95 million by 2020.
The approval of Lucentis will provide hope for seniors with wet AMD. The drug, manufactured by Genentech, Inc., is a “new molecular entity” (NME), which means that it contains an active substance that has never been approved in the U.S. for any form of marketing.
The drug, which is injected into the eye by a doctor, was shown to be effective in three clinical, randomized studies. The study included patients who were representative of the population that was typically struck with AMD. In the trials, almost 95% of the participants who got the injection once a month maintained their vision at 12 months, as compared to 60% of the patients who received the control treatment.
The results showed that a third of the patients involved in the trials experienced improved vision at 12 months. Participants taking the drug who showed an improvement in their vision could read at least three additional lines (15 letters) on the study eye chart. This was seen in 40% of the patients at the one-year mark.
Common reported side effects of the drug include eye pain, floaters, conjunctival hemorrhage, and increased eye pressure as well as inflammation of the eye. More serious side effects were rare and often associated with the injection of the drug. These included intraocular inflammation, severe inflammation of the eye’s interior (a.k.a. endophthalmitis), retinal tearing, increased eye pressure, and traumatic cataracts.
It is recommended that people with wet AMD should receive a 0.5 mg injection of the drug once a month. If this is not a workable dosage for the patient, it can be dropped down to one injection every three months after the first four monthly dosages. At the three-month injection rate, the improved vision translated to a one-line (five-letter) improvement. Regardless if your doctor prescribes Lucentis for wet AMD, you should have your vision evaluated on a regular basis.