01 Jul Iluvien Treatment for Diabetic Macular Edema
Iluvien gets closer to FDA approval for treatment of diabetic macular edema. Earlier this week, I wrote about emerging treatments for diabetic retinopathy. Of the group, Iluvien is now the most likely to be available.
Alimera Sciences has filed for NDA (New Drug Application) for Iluvien. In March, the company announced the favorable results in their clinical trials for the FDA. The NDA is the last step for FDA approval.
Iluvien Releases Steroid
Iluvien is a sustained release drug delivery system. Similar to Ozurdex, the delivery system will release steroid after injection into the eye. (Ozurdex is presently FDA approved for retinal vein occlusions, not diabetic retinopathy. The makers of Ozurdex are hopeful that it may be used for diabetes.)
The steroid released by Iluvien, fluocinolone, will last for 24 months after injection. The vehicle will remain in the eye after the drug is released.
Alternative to Present Treatments
The present treatment for diabetic macular edema involves laser treatment, anti-VEGF injections and/or steroid injections. The laser treatment has limited applications, that is, it can’t be used in all patients and also doesn’t work as well as any of the injections.
The injections, on the other hand, don’t last long and need to be repeated.
Iluvien may obviate the need for repeated treatments and offer significant improvement in vision compared to the standard laser therapy. With fewer injections, there is less chance of infection.
What Does This Mean? Ozurdex was FDA approved about one year ago. The significance of Iluvien’s NDA is the validation of the advantages of intraocular sustained release drug systems.
All emerging treatments for diabetic macular edema involve injections. All seem to offer superior treatment compared to the standard of care, laser photocoagulation. A sustained release system for diabetic retinopathy will change the way we treat this very common eye disease.
The introduction of Iluvien is estimated to be towards the end of the year according to this week’s press release.
I can’t wait.
Aissa DPosted at 12:06h, 01 July
Is Iluvien made by the same company as Ozurdex?
Randall V. Wong, M.D.Posted at 11:42h, 08 July
sorry for the delay.
Ozurdex is marketed by Allergan.
Iluvien is marketed by Alimera Sciences.
Thanks for following!
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ChrisPosted at 03:29h, 21 July
any clinical trials for this new drug? Is it safe?
Randall V. Wong, M.D.Posted at 06:53h, 21 July
Alimera Sciences has submitted NDA (New Drug Application). This is the last step to gaining FDA approval in the U.S. The clinical trials showed a good safety profile. Here is a link to another article I wrote.
More on Iluvien.
Thanks for you comments.
ChrisPosted at 05:03h, 21 July
is the new medication given by injection like AVASTIN injection? what is ment by the delivery vehicle? are we talking about implants? Thanks
Randall V. Wong, M.D.Posted at 06:55h, 21 July
Exactly. The implant will be small enough to inject into the eye via a 25 gauge “needle.” The “implant,” or vehicle, will release the medicine, and in this case, remain undissolved in the eye.
ChrisPosted at 02:26h, 22 July
Thank you Dr. Would the implant then remain in the eye after the whole medicine runs out?
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