California-based pharmaceutical company Allergan Inc. has won the approval of federal health regulators for a new use of its biodegradable eye implant Ozurdex.
On Monday, the U.S. Food and Drug Administration gave its go signal for Ozurdex (dexamethasone intravitreal implant) 0.7 mg for the treatment of vision loss in diabetic patients. The drug was previously approved to treat macular edema and non-infectious ocular inflammation but it has now been green-lighted as treatment of diabetic macular edema (DME) in adult patients who are scheduled to undergo cataract surgery or those who use artificial lens implant.
Diabetic macular edema (DME) occurs in individuals with Type 1 and Type 2 diabetes and causes the blood vessels to leak into the macula of the eye's retina. The condition causes swelling or thickening of the macula that progressively causes blurry visions, loss of vision and blindness.
Individuals who have diabetes, or over nine percent of the American population, have 10 percent elevated risks of developing DME. More than 560,000 individuals in the U.S. currently have the condition and there are about 300,000 new DME cases that develop per year.
Ozurdex uses a biodegradable solid polymer implant that releases steroid for an extended period of time to suppress the inflammation that is responsible for the development of DME. Allergan says that the implant has long term efficacy without requiring for monthly injection.
"The approval of OZURDEX(R) for certain patients with DME further strengthens Allergan's leadership position in ophthalmology and the retina subspecialty," said Scott Whitcup, Allergen's Research and Development executive vice president.
FDA'S approval was based on results of two clinical trials that demonstrated the efficacy of the implant. Common adverse events associated with the treatment that were observed in the studies include, conjunctival blood spot, foreign body sensation, retinal aneurysm, dropping eyelids, high blood pressure, retinal tear and corneal erosion.
Cataract may also occur with repeated injections and this would result in decreased vision that would require an operation to remove the cataract and restore the vision. Increased eye pressure may also occur and this needs to be managed with eye drops or with a surgery.
The Ozurdex is likewise not recommended for use by individuals with eye infections or diseases including viral diseases that affect the cornea and conjunctiva such as vaccinia, varicella, mycobacterial infections, and fungal diseases. Individuals with advanced glaucoma and those whose posterior lens capsule is not intact are also discouraged from using Ozurdex.