02 Oct Intraocular Drug System Passing FDA Testing
Earlier this week, I wrote about a device, Iluvien ™, that will release steroid into the eye. This drug delivery system is manufactured by Alimera Sciences.
Read my earlier post “Company Hopes Injectable Implant To Cure Diabetic Macular Edema.”
Alimera Sciences has announced that early data is showing that the drug system is safe and effective in humans. The results are preliminary, but promising.
Phase 2 clinical drug trials are designed to show safety of a drug at different doses. So far, after 18 of 36 months have been completed, both high and low doses of Iluvien™ appear to be safe and free from systemic side effects.
If you recall, Iluvien ™ releases fluocinalone, a steroid for the treatment of diabetic retinopathy. It is also exciting to find that both doses of Iluvien ™ may be effective at reducing macular edema and improving vision.
In short, the FDA (U.S. Food and Drug Administration) testing seems to be going as planned for the Alimera Sciences. The Iluvien drug delivery system moves another step closer to approval (after phase 2, a phase 3 clinical trial will need to be competed).
Have a great weekend.
Randall V. Wong, M.D.
Ophthalmologist, Retina Specialist