FDA Asleep at the Wheel on Ozurdex Eye Drug?

Dr. Kisling Uncategorized Leave a Comment

The FDA has approved the new drug Ozurdex  from Allergan to treat macular edema that results from a retinal vein occlusion. The treatment of retinal vein occlusions has few options and has been controversial in the past. Careful reading of the information posted by Allergan to date leads one to wonder why the drug is being marketed as a treatment.
A study with 1300 patients reported 20-30% of patients had their vision improve three lines better on the eye chart at a significantly faster rate than untreated patients. It evidently did not show any improvement over untreated patients, just a faster improvement in 20-30% of the patients. Furthermore the effect only lasted 1-3 months. Retinal vein occlusion is serious eye disorder and the macular edema often results in serious vision loss and blindness.  Unfortunately, until there is further evidence based medicine on the safety and efficacy  of Ozurdex it will remain questionable treatment in my opinion.
Ozurdex is a biodegradable implant  of the steroid drug dexamethasone designed to allow a slow extended release of the medication. The delivery mechanism is through Allergans NOVADUR solid polymer delivery system.  is delivered by an intravitreal eye injection which carries the risks associated with any injection into the eye. (Warnings and Precautions from Allergans information-Intravitreal injections have been associated with endophthalmitis, eye inflammation, increased intraocular pressure, and retinal detachments. Use of corticosteroids may produce posterior subcapsular cataracts, increased intraocular pressure, glaucoma, and may enhance the establishment of secondary ocular infections due to bacteria, fungi, or viruses. Corticosteroids should be used cautiously in patients with a history of ocular herpes simplex. Corticosteroids should not be used in active ocular herpes simplex.)

The NOVADUR solid polymer delivery system may prove to be a breakthrough technology but Ozurdex appears to be a drug with questionable value for patient outcomes. Only time will tell if this is a valuable addition or another example of the FDA asleep at the wheel.

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