Summary
Ozurdex is the first biodegradable drug delivery system for the eye. Approved for retinal vein occlusions, the off-label use will ensure wider use than the FDA approval. Ozudex may supplant intravitreal injections and the novel technology may be useful in treatment of macular degeneration and diabetics.
Analysis
The timing for a biodegradable drug delivery system for the eye could not be more timely. Allergan's "Ozurdex" is now FDA approved for treatment of retinal vascular disease. Allergan has apparently perfected a small, intravitreal, biodegradable drug delivery system designed for in office injection. Ozurdex utilizes Allergan's Novadur drug delivery system. This injectable polymeric drug delivery system, when carrying dexamethasone, will be sold as Ozurdex.
The system is introduced at a time when direct injection of substances into the eye are common place, e.g. intravitreal injections for treatment of macular degeneration. The Ozurdex system will be injected into the also in the office setting.
The drug utilized is dexamethasone, a well known and well studied corticosteroid. Retinal specialists and ophthalmologists have long been using dexamethasone or similar corticosteroids for retinal disease treatment. What is key is that while a new technology is being introduced, it employs an "old" and well know drug.
Unique to this drug-delivery system is that it is biodegradable. Similar products have similar attributes, but are not biodegradable, must be implanted surgically and may cause structural damage to the retina. In theory, this biodegradable will be small enough to "float" within the vitreous and then disappear without damage. As intravitreal injections have become the mainstay of treatment for various retinal diseases, Ozurdex may be considered a longer lasting injection.
With the wide use of intravitreal triamcinolone (another corticosteroid) injections already commonplace, there will many off-label indications for Ozurdex, e.g. diabetic macular edema.
There are several unique aspects of this soon to be released product. The drug delivery system will be Allergan's first major pharmaceutical product for treatment of retinal disease. Soon to come will be advances, using similar technology, in treatments for diabetic retinopathy and macular degeneration.
Randall V. Wong, M.D.
