Latanoprost benzalkonium chloride (BAK)-free is efficacious and well tolerated during chronic use, according to recent findings published in Clinical Ophthalmology, providing a nonpreservative option for patients with open-angle glaucoma (OAG) or ocular hypertension (OHT).
The phase 3, multicenter, open-label, nonrandomized, single group assignment, safety study (ClinicalTrials.gov Identifier: NCT00945958) evaluated the long-term safety of latanoprost BAK-free compared with latanoprost 0.005% ophthalmic solution containing BAK to treat OAG or OHT and included patients who previously completed a 12-week phase 3 noninferiority study.
Patients were instructed to self-administer 1 drop of latanoprost BAK-free nightly in the affected eye(s) for 36 weeks. The researchers assessed intraocular pressure (IOP), visual acuity (VA), and slit lamp biomicroscopy at baseline and Days 28, 56, 84, 112, 140, and 168. They also conducted dilated ophthalmoscopy and visual field (VF) assessment at baseline and Day 168 and recorded adverse events (AEs) throughout the study.
A total of 161 patients who previously received latanoprost BAK-free (n=80) or latanoprost with BAK (n=81) were enrolled in the extension study. The groups had similar baseline characteristics; the median age was 64 years (range, 27-82).
The researchers found that throughout the study latanoprost BAK-free maintained lowered IOP in the study and nonstudy eyes of all patients relative to baseline. They identified clinically significant retinal or optic nerve changes in 5 patients (prior latanoprost BAK-free group, 1 mild-to-moderate change; prior latanoprost BAK group, 4 mild changes). They found no clinically significant changes for VA, slit lamp biomicroscopy, and VF measurements.
The researchers explain that their findings “are consistent with other recent publications that collectively support the safety, tolerability, and high rates of patient satisfaction and self-reported quality of life with BAK-free latanoprost formulations, including preservative-free formulations. Results of the 12-week primary phase 3 study comparing latanoprost 0.005% without vs with BAK in OAG or OHT, which enrolled 578 patients, demonstrated that substantial reductions from baseline in IOP were maintained for the duration of the study in the latanoprost BAK-free group.”
The team reported ocular AEs in 82.5% of patients on prior latanoprost BAK-free drops and 91.4% of patients on prior latanoprost BAK drops. The most frequently reported were eye pain (prior latanoprost BAK-free vs prior latanoprost BAK, 50.0% vs 64.2%) and ocular hyperemia (47.5% vs 54.3%, respectively). No deaths or serious ocular AEs occurred.
Limitations of the study included the relatively small patient population and lack of assessment of perceptions of patient satisfaction and patient-reported quality of life.
Disclosure: This research was supported by Sun Pharma Advanced Research Company, Ltd. Some study authors declared affiliations with the biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.
Shen Lee B, Malhotra R, Sall K, Mitchell B, Peace J. Open-label extension study comparing latanoprost 0.005% without vs with benzalkonium chloride in open-angle glaucoma or ocular hypertension. Clin Ophthalmol. 2022;16(6):2285-2293. doi:10.2147/OPTH.S367756