Dexamethasone Implants for Diabetic Macular Edema

Diabetes is a raging epidemic in the United States, projected to impact nearly 600 million people within the next 20 years.¹ Diabetic macular edema (DME) and diabetic retinopathy (DR) complications affect about 25% of all patients with type 1 and type 2 diabetes and cause substantial reductions in vision and quality of life.²

DR is the leading cause of blindness among adults, with DME as the most common cause of vision loss in people who have diabetes. It’s estimated to cost around $490 million to treat the vision complications of diabetes.¹ Many people with DR are unaware they’ve developed such complications because the earliest stages are usually asymptomatic. Uncontrolled high blood sugar damages blood vessels in the eyes, which can lead to inflammation, allowing fluid and protein to seep into the macula causing swelling, blurred vision, and loss of contrast sensitivity, distorting central vision.²

Ozurdex (dexamethasone intravitreal implant), recently approved by the FDA in 2014, is indicated for retinal vein occlusion, posterior segment uveitis, and DME.³ Ozurdex works by suppressing inflammation by inhibiting multiple inflammatory cytokines resulting in decreased edema, fibrin deposition, capillary leakage and migration of inflammatory cells.³ The medication comes as one implant in an applicator and must be injected into the vitreous humor inside the eye by a health care professional in a clinic setting.

Clinical studies of Ozurdex have shown the medication’s efficacy and safety profile in patients with DME. In one clinical study, 328 patients were treated with ozdurex and 328 patients received placebo injections.³ Patients were eligible to receive an injection once every 6 months for 3 years. At the completion of the study, it was found that 20% of those who received Ozurdex gained 3 or more lines of vision in the eye chart.³ In comparison, only 11% of patients who received the placebo injections were found to have similar gains.³ It was also noted that after an injection, vision improvements peaked at about 3 months and then lowered.³ Another study evaluating the long-term efficacy and safety of Ozurdex in treating DME found that mean decrease in central retinal thickness was 315.9 µm at the 12th month and the mean best-corrected visual acuity improvement from baseline was 8.7 letters.⁴ Among both of the studies, the most commonly reported adverse effects included cataracts (68%), conjunctival hemorrhage (23%), and hypertension (13%).^3,4 The adverse effects on a general scale were rare and manageable. The increase in intraocular pressure was managed using topical intraocular pressure lowering medications and no glaucoma or cataract surgery was necessitated.⁴ This injection is contraindicated in patients who have ocular or periocular infections, glaucoma, torn or ruptured posterior lens capsules, and hypersensitivity to any components of the medication.^3,4 From the 2 studies, it was supported that Ozurdex is a safe and effective option for treatment of DME.

References

1. Holekamp NM. Overview of diabetic macular edema. Am J Managed Care. 2016;22(10):284-91. ajmc.com/journals/supplement/2016/improving-outcomes-in-diabetic-macular-edema-the-impact-of-new-therapies-in-managed-care/overview-of-diabetic-macular-edema.

2. Das UN. Diabetic macular edema, retinopathy and age-related macular degeneration as inflammatory conditions. Arch Med Sci. 2016;12(5):1142-1157.

3. About OZURDEX^® for DME. Study results. Ozurdex website. ozurdex.com/DME/Ozurdex-for-DME.

4. Matonti F, et al. Long-term efficacy and safety of intravitreal dexamethasone implant for the treatment of diabetic macular edema. Eur J Ophthalmol. 2016;26(5):454-459.