Background

This post hoc analysis compared the efficacy and safety of CLS-TA to other commonly available treatments for noninfectious uveitis (NIU).

Methods

Results from the PEACHTREE study were compared between subjects randomized to CLS-TA not requiring rescue therapy and those subjects randomized to control and subsequently requiring rescue therapy. Endpoints included best corrected visual acuity (BCVA), central subfield thickness (CST), treatment emergent adverse events (TEAEs), and intraocular pressure (IOP) related safety findings.

Results

In this analysis, there were 83 unrescued CLS-TA subjects and 46 rescued control subjects. At Week 24, 51.9% of the unrescued CLS-TA subjects gained ≥15 letters in BCVA, compared to 37.0% of the rescued control subjects (P = 0.115). Unrescued CLS-TA subjects showed a mean gain of 15.7 versus 10.9 letters in rescued control subjects (P = 0.080). A significantly greater mean reduction in CST was observed for unrescued CLS-TA subjects versus rescued control subjects (174.0 and 148.5 μm; P = 0.040). Of unrescued CLS-TA subjects, 4.9% experienced IOP elevations ≥ 30 mm Hg at any visit versus 10.9% of rescued control subjects. Further, use of IOP-lowering medications appeared lower in unrescued CLS-TA subjects versus rescued control subjects (7.2% versus 13.0%). There were no IOP-related surgical interventions in either group.

Conclusion

CLS-TA subjects experienced significantly greater reduction in CST and tended towards greater improvement in BCVA, compared with rescued control subjects. Suprachoroidally administered CLS-TA showed a lower incidence of IOP-related safety findings.

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