Three extra lines on an eye chart.
That may not seem like much at first glance (!), but those lines represent a significant step forward in the treatment of a form of diabetic retinopathy known as diabetic macular edema (DME).
In groundbreaking news this week, the Food and Drug Administration cleared the first drug of its kind to treat DME for people with diabetes, called Lucentis from California-based Genentech.
The FDA noted that this drug is for use with "good diabetic sugar control" and is designed to be given once a month as an injection into the eye by a qualified health care professional.
OK, injecting anything into your eye definitely does not sound appealing... BUT until now, those suffering from this degenerative eye condition have had to rely on laser treatments. This can slow vision loss and help stabilize a PWD's vision, but cannot actually improve vision. And this standard treatment hasn't changed in more than a quarter-century!
"Before this, macular laser treatment has been the standard of care for diabetic macular edema, and its efficacy and safety profile has not changed since 1985," said spokesman Terry Hurley at Genentech. "The goal of laser therapy timing is to intervene before vision loss, with the benefit of preventing visual decline demonstrated to outweigh the risks of the laser procedure."
But this new injectable drug marks a change in that now there is a way to actually improve vision. It's already being sent to retina specialists' offices around the country as of Wednesday, Aug. 15, Hurley said.
With more than 560,000 American PWDs living with the disease (and 55% supposedly not knowing they have DME), this is pretty huge. The FDA first approved Lucentis for treatment of other, related conditions: wet age-related macular degeneration about six years ago and (non-diabetic) macular edema following retinal vein occlusion in 2010.
The FDA approval was based on manufacturer Genentech's Phase III trials, called RIDE and RISE. Those two identically-designed, parallel, double-masked, three-year clinical trials tested 759 patients. Since Genentech joined with Roche three years ago, this Genentech discovery is part of Roche's roster of drugs.
In the trials, drug efficacy was measured by (you guessed it!) improvements in the number of lines patients could read on an eye chart. More patients who received Lucentis were able to read at least three additional lines — made up of 15 letters — on the eye chart at 24 months of treatment, or had average vision gains exceeding two lines — 10 letters each— on the eye chart at the two-year mark. They were also more likely to maintain their vision improvements.
As someone who has personally experienced early signs of diabetic retinopathy and could before long be a candidate for laser surgery, I find this significant news! OK yes, it freaks me out to think about anything being injected into my eye, but at least there's hope for vision improvement should DME set in and threaten my vision any further.
So, I'm thankful to be able to be able to welcome Lucentis, and know what this news represents to so many people.
Got diabetic eye issues? Let's talk.