A new of its kind study reports that an implantable drug delivery system for Lucentis (ranibizumab), a drug that improves vision from age-related macular degeneration(AMD), is a more convenient and promising treatment enabling patients to go 15 months in between treatments which represents a vast improvement over the typical regimen of nearly monthly eye injections.
The findings of Phase II clinical study was presented by the researchers from Wills Eye Hospital in Philadelphia at the 122nd Annual Meeting of the American Academy of Ophthalmology.
The researchers conducted a multicenter, randomized trial named LADDER study to evaluate the efficacy and safety of an investigational, long-acting port delivery system for Lucentis (ranibizumab), a drug that improves vision for millions across the globe suffering from age-related macular degeneration.
The study which enrolled 220 patients determined the time until a patient needed a refill of the implant. It also evaluated the effectiveness of three different concentrations of Lucentis compared with monthly injections of the drug.
Lucentis introduced 12 years ago soon became a promising hope for wet AMD patients as such patients have high chances to develop severe vision loss or blindness.
According to clinical trials, Lucentis was the first treatment to slow the disease, allowing more than 90 percent of patients to keep their vision but the percentage is closer to 50 percent in the real world. The probable reason behind this undertreatment was that most people with AMD must visit the ophthalmologist every six to eight weeks to keep their vision which is quite a difficult schedule to maintain for many elderly patients. Moreover, elderly patients are dependent on others to get them to the doctor.
Since Lucentis was introduced, researchers have been searching for a better alternative to monthly injections. One of the latest ideas was to surgically implant a refillable drug reservoir device, slightly longer than a grain of rice, into the eye. Filled with a concentrated version of Lucentis, the device, called the port delivery system, delivers the drug to the back of the eye over a longer time frame.
According to the researchers, patients treated with the highest drug concentration were able to go a median of 15 months before needing a refill. Port delivery treatment was also as effective as monthly injections.
“Fewer injections and office visits are exciting,” said Dr. Regillo, who administers more than 100 injections a week. “But more importantly, we think it will translate into better visual outcomes because, in the real world, patients get less treatment than they need. It’s not done consciously. Over time, things happen illness, hospitalization, a snowstorm, etc. and appointments are missed or delayed. If you’re a week or two late for a visit from time to time, you may have a decline in vision, and you can’t always recover from that. It’s a relentlessly progressive disease.”
The device is implanted under the eyelid and is not visible from outside which can be refilled after a visit to the ophthalmologist.