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Novel agent reduces inflammation, recurrence in noninfectious uveitis
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SAN FRANCISCO — A novel nonsteroidal agent caused a dose-dependent reduction in recurrence of inflammation among patients with sight-threatening noninfectious uveitis, according to a speaker.
Voclosporin (ISA247, Lux Biosciences), a calcineurin inhibitor that has also been used to treat psoriasis and used in patients with renal transplants, also helped preserve visual acuity and avoid the need for high-dose steroids as a rescue therapy, Bahram Bodaghi, MD, PhD, said during the joint meeting of the American Academy of Ophthalmology and Pan-American Association of Ophthalmology.
The data are from the phase 3 LUMINATE trial. Lux Biosciences is now working closely with the U.S. Food and Drug Administration on a fast-track application because voclosporin addresses an unmet medical need, Dr. Bodaghi said.
Patients in the study were treated with placebo or one of three dosing strengths while being tapered off of a topical corticosteroid agent. While statistically significant reductions in rates of inflammation recurrence were seen at week 22 — when corticosteroid use was finally eliminated — in the 0.4 mg/kg group and 0.6 mg/kg group, the difference at week 26 was significant only in the 0.4 mg/kg group. The 0.2 mg/kg group did not produce any significant reduction in inflammation at any time point compared with placebo, according to Dr. Bodaghi.