Table 2.
Review intervals for supplemental efficacy indications for ophthalmic drugs (calendar 2010–2020).
| Drug | Category | New indication | Submitted | Approved | Interval |
|---|---|---|---|---|---|
| Ranibizumab (Lucentis®) | Retina | Macular edema following retinal vein occlusion | 22-Dec-09 | 22-Jun-10 | 6 |
| Diabetic retinopathy in patients with diabetic macular edema | 7-Aug-14 | 6-Feb-15 | 6 | ||
| Myopic choroidal neovascularization | 11-Jul-16 | 5-Jan-17 | 5.8 | ||
| Diabetic retinopathy | 18-Oct-16 | 15-Apr-17 | 6.3 | ||
| Afilbercept (Eylea®) | Retina | Macular edema following central vein occlusion | 23-Nov-11 | 21-Sept-12 | 10 |
| Diabetic macular edema | 18-Oct-13 | 29-Jul-14 | 9.3 | ||
| Macular edema following retinal vein occlusion | 20-Dec-13 | 6-Oct-14 | 9.5 | ||
| Diabetic retinopathy due to diabetic macular edema | 30-Sept-14 | 25-Mar-15 | 9.5 | ||
| Diabetic retinopathy | 13-Jul-18 | 13-May-19 | 10 | ||
| Dexamethasone (Dextenza®) | Inflammation | Addition of post-operative inflammation indication | 10-Jan-19 | 20-Jun-19 | 6.0 |
| Difluprednate (Durezol®) | Inflammation | Uveitis | 24-Dec-08 | 14-Jun-12 | 42.3 |
Review times are calculated from initial submission until approval. These reflect FDA review time, as well as Sponsor response time in answering FDA requests for additional information.