Proportion of subjects in each arm gaining ≥ 15 ETDRS letters in BCVA from baseline at Week 24
(macular edema associated with uveitis)
(corticosteroid triamcinolone acetonide)
(diabetic macular edema)
|Retinal Vascular Disease||Proprietary Compound(s)|
|Orphan Diseases||Gene Therapy|
1. Miserocchi, E., Fogliato, G., Modorati, G. & Bandello, F. Review on the worldwide epidemiology of uveitis. European Journal of Ophthalmology 2013;23:705-717.
2. Thorne, J. E., Suhler, E., Skup, M., Tari, S., Macaulay, D., Chao, J., & Ganguli, A. Prevalence of noninfectious uveitis in the United States: A claims-based analysis. JAMA Ophthalmology 2016;134, 1237–1245.
3. Karim, R., Sykakis, E., Lightman, S. & Fraser-Bell, S. Interventions for the treatment of uveitic macular edema: a systematic review and meta-analysis. Clinical ophthalmology (Auckland, N.Z.) 2013;7, 1109–44.
4. Lardenoye, C. W. T. A., van Kooij, B. & Rothova, A. Impact of Macular Edema on Visual Acuity in Uveitis. Ophthalmology 2006;113, 1446–1449.
Table 1: Ocular Adverse Reactions Reported in ≥ 2% of Patients and Non-ocular Adverse Reactions Reported by ≥ 5% of patients
*includes cataract, cataract cortical and cataract subcapsular
Table 2: Summary of Adverse Reactions Related to Elevated IOP a
a Not associated with the injection procedure
b Includes intraocular pressure increased, ocular hypertension, and glaucoma
c Based on elevated intraocular pressure adverse reactions
Diabetic Macular Edema (DME) is an accumulation of fluid in the macula caused by leaky blood vessels as a consequence of diabetes mellitus. It is defined as retinal thickening within 2 disc diameters of the macula center. DME is the most common complication of Diabetes in patients with Diabetic Retinopathy (DR). DR affects more than 150 million people worldwide.1 It may cause images to appear blurry or wavy and colors that seem “washed out”.
1. Gupta N, Mansoor S, Sharma A, et al. Diabetic retinopathy and VEGF. Open Ophthalmol J. 2013;7:4-10.
Combination arm: Intravitreal Eylea + suprachoroidal CLS-TA (n=36)
Any additional treatment based on as needed criteria at Week 16 and Week 20 will be intravitreal Eylea