The suprachoroidal space

Drugs precisely delivered by suprachoroidal injection with access to the choroid and the retina where the diseases present. 

WATCH ANIMATION

Eye

Uveitis eye

Uveitis
(Macular Edema associated with Uveitis)

  • Uveitis is a collection of inflammatory conditions affecting the eye. Roughly 30 diseases causing inflammation in the eye fall under the classification of Uveitis.
  • Uveitis is further identified by the dominant (anatomic) location of the inflammation in the eye as anterior, intermediate, posterior, or pan uveitis.
  • Over 350,000 adults in the U.S. have uveitis. Most patients are aged 20-50 years. 2
  • Macular edema may be found with any geographic location of uveitis.3 Approximately 30-40% of uveitis patients have macular edema.4
  • There are no approved treatments for macular edema secondary to uveitis.

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.

Uveitis Phase 3: PEACHTREE Trial

  • Two-armed randomized, controlled, double-masked, multi-center trial at ~60 clinical sites
  • 3:2 randomization of suprachoroidally injected CLS-TA vs. sham injection; 160 patients total
  • Primary endpoint at week 24: Proportion of subjects in each arm gaining ≥ 15 EDTRS letters in BVCA from baseline

Peachtree

Design for Pivotal Phase 3 Clinical Trial

Peachtree Graph

Primary Endpoint

Proportion of subjects in each arm gaining ≥ 15 ETDRS letters in BCVA from baseline at Week 24

primary endpoint

Secondary Endpoint

Mean change from baseline in CST at week 24 in microns

Secondary Endpoint

Safety Summary

Table 1: Ocular Adverse Reactions Reported in ≥ 2% of Patients and Non-ocular Adverse Reactions Reported by ≥ 5% of patients

safety summary

*includes cataract, cataract cortical and cataract subcapsular

Table 2: Summary of Adverse Reactions Related to Elevated IOP a

safety summary

a Not associated with the injection procedure
b Includes intraocular pressure increased, ocular hypertension, and glaucoma
c Based on elevated intraocular pressure adverse reactions

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