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D. S. Chu, LUMINATE Investigator Group, R. L. Beckman; Cataract Formation in Patients Treated With Lx211 (Luveniq/Voclosporin Oral Capsules) With Non-Infectious Uveitis Affecting the Posterior and Anterior Segments. Invest. Ophthalmol. Vis. Sci. 2010;51(13):5877.
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© ARVO (1962-2015); The Authors (2016-present)
Determine the incidence and the rate of progression of cataract formation in noninfectious uveitis affecting the posterior and anterior segment as evaluated in the LUMINATE Studies.
The LUMINATE Uveitis Program consisted of three double-masked, placebo-controlled, parallel-group dose-ranging and multi-center trials where LX211 was used to treat active and quiescent uveitis. Subjects were randomized to one of three doses of LX211 (0.2 mg/kg, 0.4 mg/kg, and 0.6 mg/kg, all BID) or placebo. The studies were 24-26 weeks in duration with an optional 6-month extension period assessing ocular inflammation as a primary efficacy endpoint. Cataract formation was captured as an adverse event and assessed in the study and fellow eye by slit lamp examination using the AREDS grading scale. Mean change from baseline in total AREDS score was determined in each study and was compared for each treatment group. Subscales, based on types of cataract were also assessed in the same manner.
Cataract (including cataract cortical, cataract nuclear, cataract subcapsular, and cataract) as a treatment-emergent adverse event was reported in 29%, 18%, 14%, and 10% of patients in the placebo, LX211 0.2 mg/kg, LX211 0.4 mg/kg, and LX211 0.6 mg/kg dose groups, respectively. In LX211-01 study, in patients with active posterior uveitis, the mean change in baseline of total AREDS score was 0.9375, 0.7586, 0.6552, and 0.4783, for placebo, 0.2 mg/kg, 0.4 mg/kg, and 0.6 mg/kg treatment groups, respectively. In LX211-02 study, in patients with quiescent posterior uveitis, the mean change in baseline of total AREDS score was 0.5000, 0.5000, 0.3793, and 0.8421, for placebo, 0.2 mg/kg, 0.4 mg/kg, and 0.6 mg/kg treatment groups, respectively. In LX211-03 study, in patients with active nterior uveitis, the mean change in baseline of total AREDS score was 1.8333, 0.3158, 0.3846, and 0.7333, for placebo, 0.2 mg/kg, 0.4 mg/kg, and 0.6 mg/kg treatment groups, respectively.
No apparent drug-induced cataract formation was reported in the any LX211 treatment groups. In fact, a dose-related decline in cataract adverse events was observed in the LX211 treatment groups in comparison to the Placebo treatment group.
Clinical Trial: :
www.clinicaltrials.gov NCT00404612, NCT00404742, NCT00404885
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