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.
Randall V. Wong, M.D.
Ophthalmologist, Retina Specialist
Fairfax, Virginia
***This post is for information purposes only. This posting does not offer legal or medical advice, so nothing in it should be construed as legal or medical advice. The information on this blog/post is only offered for informational purposes. You shouldn’t act or rely on anything in this blog or posting or use it as a substitute for legal/medical advice from a licensed professional. The content of this posting may quickly become outdated, especially due to the nature of the topics covered, which are constantly evolving. The materials and information on this posting/blog are not guaranteed to be correct, complete, or timely. Nothing in this posting/blog and nothing you or I do creates a doctor-patient relationship between you and the blog; between you and me; or between you and Randall Wong, M.D. or RetinaEyeDoctor.com. Even if you try to contact me through the blog or post a comment on the blog you are still not creating a doctor-patient relationship. Although, I am a doctor, I’m not YOUR doctor until and unless there is a written agreement specifically providing for a doctor-patient relationship.***
Is Iluvien made by the same company as Ozurdex?
sorry for the delay.
Ozurdex is marketed by Allergan.
Iluvien is marketed by Alimera Sciences.
Thanks for following!
Randy
Dear DR.
any clinical trials for this new drug? Is it safe?
Hi Dr.
is the new medication given by injection like AVASTIN injection? what is ment by the delivery vehicle? are we talking about implants? Thanks
Dear Chris,
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.
Randy
Chris,
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.
Stay tuned!
Randy
Thank you Dr. Would the implant then remain in the eye after the whole medicine runs out?