Latanoprostene Bunod 0.024% in Patients with Open-Angle Glaucoma Switched from Prior Pharmacotherapy: A Retrospective Chart Review

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.

Keywords:

• latanoprostene bunod
• LBN
• prostaglandin analog
• PGA
• ocular hypertension
• OHT
• open-angle glaucoma
• OAG
• intraocular pressure
• IOP

Summary Points

• Latanoprostene bunod 0.024% (LBN, Vyzulta^®) is a topical nitric oxide-donating prostaglandin analog (PGA) indicated for the reduction of intraocular pressure (IOP) in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT).

• We sought to investigate the real-world efficacy and safety of LBN in patients with mild-to-moderate OAG or OHT who switched their IOP-lowering treatment(s) directly to LBN without a washout period, a population not specifically evaluated in clinical trials.

• LBN produced an additional ~25% IOP reduction, whether considering the overall dataset, the subgroup of patients previously on a PGA plus another IOP-lowering product or the subgroup of patients previously on a PGA alone; LBN appeared well tolerated with no new safety signals.

• These data may help inform clinicians on the potential effectiveness of LBN when switching patients with mild-to-moderate OAG/OHT from a prior PGA to LBN.

Data Sharing Statement

All data analyzed during this study are included in this article.

Ethics Approval and Informed Consent

The study protocol was reviewed by the Advarra Institutional Review Board (Columbia, MD, USA), which ruled that approval was not required for this study, granting a waiver of informed consent and exemption from ongoing oversight on June 7, 2021. The study adhered to the tenets of the Declaration of Helsinki as well as the Health Insurance Portability and Accountability Act privacy requirements.

Acknowledgments

The authors wish to acknowledge Megan Cavet, PhD and Heleen DeCory, PhD, employees at Bausch + Lomb at the time of study, for their work in protocol development, study design, and analysis . Statistical analyses were performed by Herbert F. Lewis, PhD (Stony Brook University, Stony Brook, NY, USA), funded by Bausch + Lomb. Medical writing assistance was provided by Kulvinder K. Singh, PharmD (KK Singh, LLC, Branchburg, NJ, USA), funded by Bausch + Lomb.

Data were presented at the 2023 American Glaucoma Society meeting (March 2-5, 2023).

Disclosure

Constance O. Okeke and Nora Lee Cothran report serving as consultants, researchers, and speakers for Bausch + Lomb. Nora Lee Cothran reports personal fees from Aerie, Alcon, Allergan/ AbbVie, Glaukos, Sight Sciences, outside the submitted work. Frank J. Rodiño is an employee of Churchill Outcomes Research that supported the study. James E. Deom reports serving as a consultant for Bausch + Lomb. Desirae A. Brinkley and Kamran Rahmatnejad have no conflicts to report.

Additional information

Funding

This study was funded by Bausch + Lomb. The Article Processing Fee was funded by Bausch + Lomb.