We conducted a matched cohort analysis evaluating visual acuity (VA) changes between interstitial cystitis (IC) patients with and without exposure to pentosan polysulfate sodium (PPS).
This retrospective, non-interventional cohort study (NCT05179460) using data from the American Academy of Ophthalmology IRIS (Intelligent Research in Sight) Registry and Komodo Health database from 1 January 2015 to 1 March 2021 assessed VA changes in two matched cohorts of IC patients: "PPS-Exposed Cohort," and "Non-PPS-exposed Cohort. " Best documented VA was evaluated using VA conversion methods (e.g. from Snellen chart VA to logMAR units and letters).
A total of 6,418 matched IC patients (PPS-Exposed Cohort, n = 3209; Non-PPS-exposed Cohort, n = 3209) were included in the analysis. Baseline characteristics were generally similar between the two matched cohorts. Through 36 months of follow-up, the observed mean (Standard Deviation; SD) changes from baseline in VA decreased by 0.02 (0.62), 0.71 (6.87), 0.83 (7.47), 0.94 (6.96), 1.35 (7.64), and 1.63 (8.93) letters every 6-months from 12 to 36-months in the PPS-Exposed Cohort. In contrast, for the Non-PPS-exposed Cohort, the observed mean changes (SD) in VA decreased by 0.03 (0.79), 1.22 (7.28), 1.18 (7.21), 1.43 (7.74), 1.29 (8.44), and 1.87 (9.65) letters over the same timeframe. VA changes were further evaluated by several subgroups, including age, sex, and race. The results showed a greater reduction of VA over time in older patients, with a pattern that was similar in both the PPS-Exposed and Non-PPS-exposed cohorts.
Over the 36 months of follow-up period, this matched cohort analysis found no supporting evidence that PPS exposure in IC patients impacted the progression of VA compared to those patients not exposed to PPS.
Current medical research and opinion. 2026 Apr 16 [Epub ahead of print]
Zhong Yuan, Subusola Vaughan, Carolyn Jeffcoat, Peter Hu, Ritchie Yuson, Durga Borkar
Department of Epidemiology, Johnson & Johnson, Horsham, PA, USA., Department of Established Products, Johnson & Johnson, Titusville, NJ, USA., Global Medical Safety, Johnson & Johnson, Horsham, PA, USA., Department of US Statistics and Decision Science, Johnson & Johnson, Raritan, NJ, USA., Global Medical Safety, Johnson & Johnson, Irvine, CA, USA., Department of Ophthalmology, Verana Health, San Francisco, CA, USA.