FDA Approves Lucentis® (Ranibizumab Injection) for Treatment of Diabetic Macular Edema (DME)

#1

Press Release

-- First Major Treatment Advance in More Than 25 Years for Sight-Threatening Condition --

South San Francisco, Calif. -- August 10, 2012 -- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that Lucentis® (ranibizumab injection) was approved by the U.S. Food & Drug Administration (FDA) for treatment of diabetic macular edema (DME), an eye condition in people with diabetes that causes blurred vision, severe vision loss and sometimes blindness. Diabetes is now the leading cause of new cases of blindness in American adults1 and DME is estimated to affect more than 560,000 Americans with the disease.2


Lucentis is the first and only FDA-approved medicine for DME, a condition for which the standard of care has not changed significantly in more than 25 years. To date, the standard of care in the U.S. for DME has been laser surgery, which slows the rate of vision loss and helps stabilize vision, but has demonstrated only limited ability to restore lost vision.3


"For the first time, Americans with diabetic macular edema will have access to an FDA-approved medicine shown to help many patients rapidly regain substantial amounts of lost vision," said Hal Barron, M.D., chief medical officer and head, Global Product Development. "We developed Lucentis to treat diseases of the eye and are pleased to have received this third U.S. indication to help a new population of people whose eyesight may be affected by diabetes."

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Lucentis
#2

I was a participant in the trials for this treatment. It wasn't really effective in my case, but I'm glad to see that it helps some patients!

#3

I just had an injection of lucentis yesterday, they said I would have to have injections for the rest of my life. every thing I have read is saying significant improvment after a couple of months to a year. Am I to understand to keep my vision I have to become friends with lucetis on a monthly schedule? I believe I am still in shock. was diagnosed with DME, anyone else taking this? I am in Canada and sure hope my insurance will cover this, being $2000.00

#4

My son is currently being treated with Lucentis in both eyes. He has mild to moderate DME. His macular edema is resolving. However, he is a newly diagnosed type 1 since August. He has literally halved his A1c to 5.0. I really think the improvement in his DME is largely due to his getting his bgs under control. Lucentis may have helped. Please note that getting eye injections has a significant risk in itself. My son is now dealing with a cornea infection at the injection site. The infection is clearing up, but he is suffering from blurred vision because of it.
My advice would be to keep the bgs as tightly controlled as possible in the normal range and see if that improves the DME before resorting to eye injections, especially if your DME is mild and your visual acuity is good. One needs to take a good hard look at proposed drug treatments. Besides, Lucentis is obscenely expensive which should not be the case.

#5

thanks for the Reply Cary, I have had this a while just hadn't gone to the specialist, eye doctor was keeping an eye on it, but well it got worse and I do have blurred vision so they wanted to treat me right away and hope that it improves. they only did it in my left eye yesterday so not sure if they are going to do my right eye next month or the left again. unsure, as for the risks was reading them, I have to put drops in my eyes 6x a day for 5 days so that I do not get an infection after the injection, so crossing fingers. I have been type 1 Diabetic for 14 years just this past year I have been treated for whole body nerve damage, fast heart beat, and now this. ugggg, my A1C's range between 5.9 - 6.8 so good in that area.

Price I agree that is insane, wondering however is it $2000.00 per treatment or per eye? LOL

#6

How long should it take before seeing results? I have only had the one injection so far, the next month is coming up fast however and still not sure if it is covered. I seem to see better in the eye that did not get the injection though so wondering how long before you actually see results? and is this something I would need every month for the rest of my life? also wondering if the cost is per eye or per treatment?

#7

Hi dishers,
My son has received 3 Lucentus injections, 2 in his right eye and 1 in his left eye. The right eye responded dramatically to the injections reducing the swelling by about 200 microns by the second week after the second injection. Unfortunately it looks like the effects are wearing off, the swelling is back up to around 300 microns although the contour of the macula has remained improved. He developed a herpes type infection in the cornea of his left eye after an injection. It is receding but he is still experiencing clouded vision. He is scheduled to have another injection tomorrow in his right eye. I appreciate the fact that his doctor is extremely proactive in treating his retinopathy while his vision is still excellent. Yet, we have to balance the number of doctor visits, already 8 times this month alone and the unpleasantness of getting the injections with the possible benefits of the drug. I don't think the doctors know whether the lucentus will permanently stabilize the edema or not. It definitely has a short term effect. You would probably notice a difference in two weeks. The cost of our treatments are $2,000 per injection, covered by insurance. Good luck with what you decide to do, and hopefully you won't have to go through monthly injections to achieve stabilization.

#8

My doctor has suggested Lucentis injections in my right eye due to leaking fluid. I was told that that the number of injections and timing would depend on how I respond, but probably monthly for six months. I am a bit freaked out by the whole procedure, but am glad that they can do something. The leak is in the center of my vision, so they can't do laser treatments.
...and yes the cost is crazy. Any advice?

#9

Since I posted, I have had my Left eye, then none then the right eye. have to go every 6-8 weeks, as you have mentioned they can't tell me until he has looked, he wanted to keep checking that my glucoma was ok as well so far it is. I have noticed once I get an injection that month sometimes I need my glasses some days I don't. I asked about this and he told me it is my diabetes not the injections. so why is it that my sugars are in good control and when I don't get one my eyes do not change on a daily basis? I think it is the injection but don't know for sure.