FDA approves Genentech's Lucentis (ranibizumab injection) for diabetic retinopathy, the leading cause of blindness among working age adults in the United States. Press release issued by Genentech in April 2017.
Alimera Sciences provides details on FDA approval of Iluvien as the first long-term treatment for diabetic macular edema. Press release issued by Alimera Sciences in September 2014.
Allergan announces FDA approves revised indication for Ozurdex (dexamethasone intravitreal implant) mg for the treatment of diabetic macular edema. Press release issued by Allergan in September 2014.
Allergan receives FDA approval for Ozurdex (dexamethasone intravitreal implant) mg as treatment option for use in certain patients with diabetic macular edema. Press release issued by Allergan in June 2014.
Treatment of diffuse diabetic macular oedema using steroid eye drops. Acta Ophthalmologica. November 2012.
FDA approves Lucentis to treat diabetic macular edema. FDA press release issued in August 2012.
Dexamethasone drug delivery system (Ozurdex) for the treatment of refractory diabetic macular oedema: retrospective case series analysis. Acta Ophthalmologica. Published online ahead of print in August 2012.
Ranibizumab for diabetic macular edema: results from 2 phase III randomized trials: RISE and RIDE. Ophthalmology . April 2012.
Long-term safety, high-resolution imaging, and tissue temperature modeling of subvisible diode micropulse photocoagulation for retinovascular macular edema. Retina. Published online ahead of print, November 2011.
The RESTORE study: ranibizumab monotherapy or combined with laser versus laser monotherapy for diabetic macular edema. Ophthalmology . April 2011.
National Diabetes Fact Sheet: National estimates and general information on diabetes and prediabetes in the United States, 2011. Department of Health and Human Services, Centers for Disease Control and Prevention. 2011.
Effects of intensive glucose lowering in type 2 diabetes. New England Journal of Medicine . July 2010.
Diabetic retinopathy. Cleveland Clinic: Current Clinical Medicine, 2nd ed. 2010.
Serous detachment of the neural retina. Ophthalmology, 3rd ed. 2008.
Comparison of the Modified Early Treatment Diabetic Retinopathy Study and mild macular grid laser photocoagulation strategies for diabetic macular edema. Archives of Ophthalmology. April 2007.
Study AMD-3 was a randomized, double-masked, sham-controlled, two-year study designed to assess the safety and efficacy of LUCENTIS in patients with neovascular AMD (with or without a classic CNV component). Data are available through Month 12. Patients received LUCENTIS mg or mg intravitreal injections or sham injections once a month for 3 consecutive doses, followed by a dose administered once every 3 months for 9 months. A total of 184 patients were enrolled in this study (LUCENTIS mg, 60; LUCENTIS mg, 61; sham, 63); 171 (93%) completed 12 months of this study. Patients treated with LUCENTIS in Study AMD-3 received a mean of 6 total treatments out of a possible 6 from Day 0 through Month 12.
Numerous trials (CATT trial, IVAN trial, GEFAL, MANTA, LUCAS) conducted worldwide have shown Bevacizumab injection in the eye to be non-inferior to Ranibizumab injection in the eye in terms of efficacy and safety in AMD. Bevacizumab on the other hand has the advantage of significantly reducing the cost of therapy. However, intravitreal bavacizumab injection has not been approved by the Food and Drug Administration (FDA) and the use in the eye is hence 'off label'. All patients need to be clearly informed when taking written consent for intraocular bevacizumab.