ABSTRACT
Introduction: Latanoprostene bunod 0.024% (LBN, Vyzulta®) is a nitric oxide-donating prostaglandin analog (PGA). We investigated the real-world efficacy and safety of LBN in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT) who switched their existing intraocular pressure (IOP)-lowering treatment(s) to LBN. Methods: This non-interventional, multicenter (United States), retrospective chart review included patients aged ≥18 years with OHT and/or mild-to-moderate OAG diagnoses taking 1-2 IOP-lowering treatments at the time of switch to LBN (index visit). Chart-extracted data included demographics, diagnoses, IOP and ocular assessments, other IOP-lowering treatments, adverse events (AEs), and reasons for discontinuation. The main study outcome was IOP change from the index visit to each of the next 2 chart-recorded follow-up visits. Analysis groups included the overall dataset and 2 subgroups of patients switched from PGA therapy to LBN: "PGA-all" subgroup [all patients previously on a PGA with/without another IOP-lowering product] and "PGA-monotherapy" subgroup [patients previously on a PGA alone]). Additional ocular outcomes (eg, visual acuity) were examined, if available. Results: The overall dataset included 49 patients (46 had OAD alone, 2 had OHT alone, and 1 had both). The PGA-all subgroup and PGA-monotherapy subgroups had 41 and 32 patients, respectively. Switching to LBN led to a ~25% IOP reduction from the index visit to Visit 1 that was sustained at Visit 2. IOP findings in the PGA-all and PGA-monotherapy subgroups were consistent with the overall dataset. No meaningful changes in other ocular outcomes were found. Of 14 ocular AEs, 3 were recorded as such (mild in severity, considered unrelated to treatment), and 11 were identified through review of interval ocular histories (no severity/relatedness information); none led to discontinuation. Conclusion: In this short-term retrospective chart review of mild-to-moderate OAG/OHT, switching prior IOP-lowering therapy to LBN produced an additional ~25% IOP reduction and appeared to be well tolerated.
ABSTRACT
INTRODUCTION: The objective of this study was to evaluate real-world effectiveness of latanoprostene bunod (LBN) ophthalmic solution 0.024% in treatment-naïve patients newly diagnosed with open-angle glaucoma (OAG) or ocular hypertension. METHODS: This multicenter retrospective chart review included patients aged ≥ 18 years, with no history of medical, laser, or surgical intraocular pressure (IOP)-lowering intervention and at least two follow-up visits (spanning ≥ 2 months) following initiation of LBN treatment. Extracted data included age, sex, race, cup-to-disk ratio, central corneal thickness, IOP, visual acuity (VA), concomitant medications, and adverse events. In patients treated bilaterally, the eye with the higher baseline IOP was the study eye. RESULTS: Medical charts for 65 patients (mean [SD] age, 59 [14] years; 53.8% female) encompassing 125 eyes treated with LBN were reviewed across nine clinical sites. Mean (SD) IOP at baseline was 21.7 (5.9) mmHg. Mean days to first and second follow-up visit were 43 and 141, respectively. LBN use resulted in a mean (SD) reduction from baseline of 7.1 (4.7) and 7.3 (5.1) mmHg at the first and second follow-up visits, respectively (P < 0.0001 for both). Reductions among patients with IOP > 21 mmHg (n = 30) at baseline were 10.0 (4.5) and 11.1 (4.6) mmHg at the first and second follow-up visits (P < 0.0001 for both). There were no meaningful changes in VA. Adverse events appeared infrequent, with only one report of ocular redness. CONCLUSION: In this real-world, retrospective chart review, LBN 0.024% use resulted in robust IOP lowering in newly diagnosed OAG patients new to treatment, and appeared well tolerated.
