Safety of Fixed-Combination Bimatoprost 0.03%/Timolol 0.5% Ophthalmic Solution at 6 Months in Chinese Patients with Open-Angle Glaucoma or Ocular Hypertension

Xinghuai Sun, Ke Yao, Qinghuai Liu, Hong Zhang, Xiaoli Xing, Aiwu Fang, Xuanchu Duan, Minbin Yu, Michelle Y Chen, Jingyuan Yang, Margot L Goodkin, Xinghuai Sun, Ke Yao, Qinghuai Liu, Hong Zhang, Xiaoli Xing, Aiwu Fang, Xuanchu Duan, Minbin Yu, Michelle Y Chen, Jingyuan Yang, Margot L Goodkin

Abstract

Introduction: Fixed-combination bimatoprost 0.03%/timolol 0.5% ophthalmic solution (FCBT; Ganfort®, Allergan, an AbbVie company) effectively reduces intraocular pressure (IOP) via complementary mechanisms of action of the agents, but long-term (> 12 weeks) safety evaluations of FCBT remain limited. FCBT safety is evaluated herein, with particular focus on hyperemia and eyelash growth, at 24 weeks in Chinese patients with open-angle glaucoma (OAG) or ocular hypertension (OHT).

Methods: In this multicenter, open-label, noncomparative, phase 4 study conducted in China, patients diagnosed with OAG or OHT having insufficient response to β-blocker- or prostaglandin analogue/prostamide (PGA)-based IOP-lowering monotherapy in one or both eyes were switched from their current IOP-lowering treatment to FCBT (one drop per eye every evening) without prior washout. Assessment visits were scheduled at baseline and weeks 4, 12, and 24 (or study exit). The primary outcome measure was adverse event (AE) incidence through 24 weeks.

Results: Of 725 patients enrolled, 632 (87.2%) completed the study; 93 (12.8%) patients discontinued, including 29 (4.0%) due to AEs. Of 1326 FCBT-treated eyes (total), 594 (44.8%) experienced ≥ 1 ocular treatment-related AE during the study. Conjunctival hyperemia (the most common AE overall) and eyelash growth were reported in 269 (20.3%) and 54 (4.1%) FCBT-treated eyes, respectively. The incidence of other known PGA-related AEs (including blepharal pigmentation and erythema of eyelid) was < 10% each. Most conjunctival hyperemia reports were mild in severity (214/259; 82.6%) and only 1/259 (0.4%) was severe. Similarly, most cases of eyelash growth were mild (46/52; 88.5%); none were severe. One (< 0.1%) FCBT-treated eye had a serious ocular AE (OAG) considered FCBT-related.

Conclusions: The frequency and severity of FCBT-related AEs, including conjunctival hyperemia and eyelash growth, are consistent with previously published findings. No new safety concerns were raised. This prospective study reaffirms that once-daily FCBT is a safe and well-tolerated therapy for OAG and OHT.

Gov identifier: NCT02571712.

Keywords: Bimatoprost; Fixed combination; Glaucoma; Intraocular pressure; Ocular hypertension; Safety; Timolol.

Conflict of interest statement

Financial arrangements of the authors with companies whose products may be related to the present report follow, as declared by the authors. Xinghuai Sun, Ke Yao, Qinghuai Liu, Hong Zhang, Xiaoli Xing, Aiwu Fang, Xuanchu Duan, and Minbin Yu have nothing to disclose. Jingyuan Yang and Margot L. Goodkin are employees of AbbVie. Michelle Y. Chen is an employee of Perfuse Therapeutics, Inc., and was an employee of Allergan (an AbbVie company) when the study was conducted.

© 2022. The Author(s).

Figures

Fig. 1
Fig. 1
Patient disposition. AE adverse event, FCBT fixed-combination bimatoprost 0.03%/timolol 0.5%. aTwo (0.3%) patients had both ocular and nonocular AEs. bThe most commonly reported protocol deviations leading to discontinuation were patients not undergoing protocol-specified assessments or procedures, and use of prohibited concomitant medications during the study
Fig. 2
Fig. 2
Incidence of A, B conjunctival/ocular hyperemia and C, D eyelash growth as adverse events of special interest, by severity. aFive eyes had both growth and thickening of eyelash

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