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Sumit Sharma, Allen Hu, Colette Hall, Barry Kapik, Thomas A Ciulla; Safety of Suprachoroidal Injection Procedure Utilizing a Microinjector across Three Retinal Disorders. Invest. Ophthalmol. Vis. Sci. 2021;62(8):1209.
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© ARVO (1962-2015); The Authors (2016-present)
Suprachoroidal injection (SCI) via SCS Microinjector® is an investigational ocular injection providing high, compartmentalized drug concentrations to chorioretinal layers via the suprachoroidal space (SCS). This post hoc study evaluated safety of SCIs across multiple clinical trials involving an investigational proprietary suspension of triamcinolone acetonide (CLS-TA), focusing on events occurring peri-procedurally.
Datasets from 8 clinical trials involving three disease states: noninfectious uveitis (NIU), diabetic macular edema (DME) and retinal vein occlusion (RVO) and included patients who received one or more SCI, either as monotherapy or with intravitreal (IVT) anti-VEGF. Procedure-related ocular serious adverse events (SAEs) assessed, occurring rarely with intraocular injections, included lens injury, suprachoroidal hemorrhage, retinal tear, retinal detachment, endophthalmitis, and reduced visual acuity. Treatment emergent adverse events (TEAEs) assessed included eye pain on the day of the procedure. Outcomes were compared to control eyes randomized to receive IVT anti-VEGF monotherapy and sham SCI.
621 patients received one or more SCI, either as monotherapy (N=161) or with IVT aflibercept (N=460). 3 of 621 patients experienced 3 SAEs of interest, all occurring in patients receiving multiple injections. One NIU monotherapy patient had a retinal detachment, and 2 RVO patients receiving combination therapy had reduced vision; each were deemed not related to treatment by a masked Investigator. There were no SAEs involving lens injury, suprachoroidal hemorrhage, endophthalmitis, or retinal tear in patients receiving SCIs, either alone or in conjunction with anti-VEGF. 449 control patients received IVT anti-VEGF in conjunction with a sham SCI. Three RVO patients experienced 3 SAEs of interest, including retinal detachment, vitreous hemorrhage and endophthalmitis. Each were deemed not related to treatment by a masked Investigator. Of 621 patients undergoing SCIs (161 as monotherapy, and 460 in conjunction with IVT injection), 37 (6%) experienced a TEAE related to eye pain, compared to control, 7 of 449 (1.6%) undergoing IVT injection.
Across 8 clinical trials involving NIU, DME and RVO, the safety profile of SCI, either as monotherapy or in conjunction with IVT injection, is comparable to IVT injections alone for events occurring at or after the procedure.
This is a 2021 ARVO Annual Meeting abstract.
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