The suprachoroidal space

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

WATCH ANIMATION

Eye

Focused Pipeline of SCS Treatments for Multiple Blinding Eye Disease

Indication

Study drug

Current Status

Uveitis
(macular edema associated with uveitis)
Suprachoroidal CLS-TA
(corticosteroid triamcinolone acetonide)
row1
DME
(diabetic macular edema)
Suprachoroidal CLS-TA row3
Retinal Vasular Disease Proprietary Compound(s) row4
Orphan Diseases Gene Therapy row5

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

Diabetic Macular Edema (DME)

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.

Diabetic Macular Edema Phase 2: TYBEE Trial

  • Controlled, masked, randomized study of combination suprachoroidal CLS-TA + intravitreal Eylea vs. intravitreal Eylea alone
  • Evaluation at Month 6; treatment is based on PRN criteria from Month 3
  • Primary outcome measure is comparison of mean change from baseline in BCVA at 24 weeks between the combination arm and the control arm. The study was powered and designed to show that the mean change in BCVA is not different between the two arms.

Combination arm: Intravitreal Eylea + suprachoroidal CLS-TA (n=36)

Tybee chart

Any additional treatment based on as needed criteria at Week 16 and Week 20 will be intravitreal Eylea

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