05 Jan 2010: "Year of the…Drug Delivery System?"
2010 may be the year of drug delivery systems. Icon Bioscience, Inc., (IBI) has announced their initiation of Phase 2 and Phase 3 clinical trials for an injectable sustained release system for the use in cataract surgery. Their product, under the code name IBI-10090, will release anti-inflammatory drug for 2-3 weeks after cataract surgery. It is hoped that this will obviate the need for the standard anti-inflammatory drops used following cataract surgery.
Similar products, namely Ozurdex™ (Allergan), Iluvien® (Alimera) and I-vation™ (Surmodics) are also sustained release platforms, but all focused on the treatment of diabetic retinopathy or macular degeneration.
Ozurdex has already been FDA approved (and thus, available to the public) for the treatment of retinal vein occlusions. It is a sustained release system that releases a steroid, dexamethasone, to reduce macular swelling/edema following retinal vein occlusions. I suspect it will have “off-label” uses for both diabetic macular edema and wet macular degeneration.
Iluvien also releases a steroid. The steroid, fluocinolone, will be released for the treatment of diabetic macular edema. Their Phase 3 clinical trial should be ending soon and will be awaiting FDA approval.
Surmodics is hopeful that their I-vation system can be used to treat macular degeneration. Previously, I wrote about their hopes to combine the I-vation delivery system with Lucentis for the treatment of wet macular degeneration. This should, at the very least, reduce the number of intravitreal injections. It is also testing a product that releases steroid for diabetic retinopathy.
What Does This Mean? IBI is the latest to enter the sustained release market for ophthalmic drug delivery. There are now at least 4 companies focused (no pun intended) on extended release technology for the eye. It is the technology that is most exciting.
All of these delivery systems are expected to be versatile. They should be able to “carry” or deliver any number of different drugs depending upon the intended disease to be treated. For instance, while Ozurdex presently carries a steroid, it could easily carry (Novadur is the actual name for Allergan’s delivery technology) anti-VEGF drugs, etc.
While IBI is entering the market with a system for post-surgical cataract treatment, a similar product is in the IBI pipeline for the treatment of retinal diseases, such as diabetic retinopathy and macular degeneration.