An announcement from Bausch + Lomb and Clearside Biomedical have reported that the US FDA granted approval to triamcinolone acetonide injectable suspension (“XIPERE”) for suprachoroidal use for the treatment of macular oedema associated with uveitis. The product is a proprietary preservative-free formulation of triamcinolone acetonide (TA), and the injection is performed as an in-office procedure using a proprietary syringe and needle platform (SCS Microinjector).
Following the approval by the FDA, the earlier research reported the results of two clinical trials: “PEACHTREE” and “MAGNOLIA”. The Phase III PEACHTREE study (with Clinicaltrials.gov reference NCT02595398) used CLS-TA (suprachoroidal injection of triamcinolone acetonide injectable suspension) for macular oedema (ME) due to non- infectious uveitis (NIU) enrolled 160 patients, randomised 3:2 to CLS-TA or sham with 2 administrations delivered 12 weeks apart. In the CLS-TA arm, 47% of patients gained ≥15 Early Treatment Diabetic Retinopathy Study (ETDRS) letters in best corrected visual acuity (BCVA) versus 16% in the control arm (p<0.001), meeting the primary endpoint at week 24. Thereafter, the primary objective of the MAGNOLIA extension study (with Clinicaltrials.gov reference NCT02952001) was to evaluate the efficacy of CLS-TA up to 24 weeks following exit from PEACHTREE, as shown by the need for additional (rescue) therapy for the signs or complications of uveitis. The secondary objective of MAGNOLIA was to determine the safety of CLS-TA, assessed as treatment-emergent adverse events (TEAEs), on-study AEs, changes in IOP and changes in cataract grading up to 24 weeks following exit from PEACHTREE.
According to the recent research report, the median time to rescue therapy was 257 days versus 55.5 days for the CLS-TA and sham-control arms, respectively, over the entire 48-week period for PEACHTREE and MAGNOLIA. Of 28 CLS-TA treated patients who participated in MAGNOLIA, 14 (50%) did not require rescue therapy through approximately 9 months after the second treatment. Among CLS-TA patients not requiring rescue, there was a mean gain of 12.1 letters and mean CST reduction of 174.5 μm at week 48. Commenting on study data Dr. Yeh, as a consultant to Clearside Biomedical, Bausch + Lomb stated that, “the procedure used for suprachoroidal TA injection is a nuanced technique. However, it is very reproducible, can be learned by any ophthalmologist who is comfortable administering intraocular injections, and is well-tolerated by patients”.