(C-028) A Retrospective, Non-interventional Cohort Study of Visual Acuity Changes in Patients with Interstitial Cystitis Receiving Pentosan Polysulfate Sodium

Background: Pentosan polysulfate sodium (PPS) is currently the only FDA-approved oral medication for treating interstitial cystitis (IC), a condition characterized by urinary urgency, frequency, nocturia, and bladder pain. Although some reports have linked PPS use to pigmentary maculopathy and pigmentary retinopathy, a clear causal relationship has not been established. Additionally, the effect of PPS on visual acuity (VA) in IC patients has not been fully examined.

Objectives: This study (ClinicalTrials.gov: NCT05179460) aims to assess VA changes in IC patients with and without exposure to PPS using a matched cohort analysis.

Methods: We performed a retrospective, non-interventional cohort analysis using data from the American Academy of Ophthalmology IRIS® Registry and the Komodo Health database, covering January 1, 2015, to March 1, 2021. Eligible patients were adults with at least two VA measurements. For PPS-exposed patients, the baseline VA was determined as the last measurement taken within 12 months before or on the first PPS exposure date (with the VA measurement date as the index date [Day 0] for subsequent analysis). Non-PPS exposed patients needed a VA measurement within 6 months of the PPS group's index date for inclusion. The PPS-exposed and non-exposed patients were matched 1:1 by age, sex, time of baseline VA measurement, and baseline VA severity. The outcome was assessed using best documented VA. VA conversion methods (e.g., from Snellen chart VA to logMAR units and letters) followed previous literature. VA changes were descriptively evaluated over three years at 6-month intervals. VA measurements within 6 months of each time point were considered valid for the corresponding time interval's analysis. Patients were censored from the analysis at the time of cataract surgery, glaucoma-related procedures, or the initiation of PPS treatment in the non-PPS exposed cohort.

Results: The study included 3,209 matched patient pairs. Baseline characteristics and VA measurements were similar between the PPS-exposed and non-exposed groups. Over the 36-month follow-up, mean changes in VA (SD) for the PPS group were decreases of 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 at each 6-month interval. The non-exposed group showed declines of 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 periods. Subgroup analysis by age, sex, and race revealed greater VA reductions in older patients across both cohorts.

Conclusions: Over the 36 months of follow-up period, this matched cohort analysis found no supporting evidence that PPS exposure in IC patients affects the progression of visual acuity compared to those without exposure.