FDA Approval of New Drug: Allergan’s Ozurdex

June 30, 2009
Dear Colleague,

Retina Consultants of Southwest Florida®, along with our in-house research facility, the National Ophthalmic Research Institute™ (NORI), is proud to announce the U.S. Food and Drug Administration’s (FDA) approval of the first drug-therapy for macular edema due to retinal vein occlusion.

Allergan’s Ozurdex just received FDA approval and will soon be available for public use. Administered into the eye via injection by the physician, the Ozurdex implant delivers an extended release dose of the corticosteroid, dexamethasone, to the retina. In clinical studies, patients achieved an average of a three-line improvement when reading from an eye chart compared to those patients who received a placebo.

The FDA approval of Ozurdex comes after several years of clinical testing. NORI has been at the forefront of Ozurdex’s clinical trials and is one of Allergan’s largest patient enrolling sites in North America, participating in multiple studies with Ozurdex.

The FDA approval is proof of how important the years of clinical studies are to finding new treatments for diseases. Because Retina Consultants of Southwest Florida offers a clinical testing site, we can allow patients the opportunity to participate in studies when there are no other options for treatment.

Once Ozurdex is on the market, it may also be used as treatment for other eye diseases such as diabetic macular edema and macular degeneration. Abnormal functioning retinal vessels found in these diseases may work better when treated with steroid medications.

We are very excited about Ozurdex. It has the potential to save the vision of countless patients who would otherwise not have treatment options and potentially lose vision. If you have a patient whom you feel may benefit from Ozurdex or who may be a candidate for any of our ongoing clinical studies, please call our office. If you have questions regarding any clinical trials, please contact NORI at (239) 938-1284.

Best regards,
Joseph P. Walker, MD
Glenn L. Wing, MD
Paul A. Raskauskas, MD
Tom Ghuman, MD
Ashish G. Sharma, MD, FACS
Donald C. Fletcher, MD