LUMIGAN® (bimatoprost ophthalmic solution)
LUMIGAN® (bimatoprost ophthalmic solution 0.03% MD)
LUMIGAN® (bimatoprost ophthalmic solution 0.03% UD)
What is the safety profile of LUMIGAN® 0.01%?
LUMIGAN® 0.01% offers you and your patients the reassurance of an established tolerability profile1
In a 12-month Phase III clinical study, approximately 38% of patients treated with LUMIGAN® 0.01% experienced adverse reactions. The most frequently reported adverse event was conjunctival hyperemia (mostly trace to mild and of a non-inflammatory nature), which occurred in 28.6% (n=53/185) of patients.1,2
The majority of adverse reactions reported in clinical studies or in the post-marketing period using LUMIGAN® 0.01% were ocular, mild, and none were serious.*,1,2
Adverse events leading to discontinuation occurred in approximately 4% of patients.*,2 Ocular adverse events leading to discontinuation occurred in 2.2% of patients.*,2
* Results of a 12-month prospective, randomized, double-masked, multi-center clinical trial evaluating the IOP-lowering efficacy and safety of LUMIGAN® 0.01% (n=186) and LUMIGAN® 0.03% MD (n=187) in patients with glaucoma or ocular hypertension.2
Please refer to LUMIGAN® 0.01% Summary of Product Characteristics for further information on safety adverse events.
Very common and common adverse events associated with LUMIGAN® 0.01% in the post-marketing period1
| System Organ class | Frequency | Adverse reaction |
|---|---|---|
| Eye disorders | Very common | Conjunctival hyperemia, prostaglandin analog periorbitopathy |
| Common | Punctuate keratitis, eye irritation, eye pruritus, growth of eyelashes, eye pain, erythema of eyelid, eyelid pruritus | |
| Skin and subcutaneous tissue disorders | Common | Skin hyperpigmentation, hypertrichosis |
| General disorders and administration site conditions | Common | Instillation site irritation |
Adapted from LUMIGAN® 0.01% Summary of Product Characteristics. 2022.1
Please refer to the Summary of Product Characteristics for full details of adverse events associated with LUMIGAN® 0.01%.
LUMIGAN® 0.01% may result in reduced global clinical score
from baseline3
Global clinical score (the sum of pruritus, stinging/burning, blurred vision, sticky eye sensation, eye dryness sensation, and foreign body sensation) significantly decreased in the LUMIGAN® 0.01% group from baseline (4.7±3.8 to 2.9±2.3 [p<0.001] and 2.5±2.0 [p<0.001]) at 6-month and 12-month follow-ups, respectively.**,3
**Results of a randomized, prospective, parallel-group, open-label, cohort study. A total of 60 glaucoma patients (60 eyes; POAG, pseudoexfoliation glaucoma, and pigmentary glaucoma) under LUMIGAN® 0.03% monotherapy since at least 1 year were enrolled. Patients were enrolled from the Glaucoma Unit of Pisa University in Italy and analyzed from March 2011 to September 2012. Selected patients were randomized to receive one daily drop of LUMIGAN® 0.01% (n=30) or LUMIGAN® 0.03% (n=30) for 12 months.3
The tolerability of LUMIGAN® 0.01% was rated as ‘good’ or ‘very good’ by the majority of patients and physicians4
Physicians rated the tolerability of LUMIGAN® 0.01% as ‘good’ or ‘very good’ in 92.6% of their patients (N=10,337)†,4
Patients (N=10,337) rated the tolerability of LUMIGAN® 0.01% as ‘good’ or ‘very good’ in 89.3% of cases†,4
† Results of a multicenter, prospective, open-label, observational study designed to investigate the efficacy and tolerability of LUMIGAN® 0.01% in routine clinical practice in Germany in 2012 (N=10,337). Adverse events were reported in 6.1% of patients (n=629/10,337) with the most commonly reported adverse events being eye irritation (2.0%), ocular hyperemia (1.4%) and conjunctival hyperemia (1.2%).4
Real-world evidence is collected outside of controlled clinical trials and has inherent limitations including a lesser ability to control for confounding factors.
Reporting of suspected adverse reactions
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LUMIGAN® 0.01% is indicated for the reduction of elevated intraocular pressure in chronic open-angle glaucoma and ocular hypertension in adults (as monotherapy or as adjunctive therapy to beta-blockers).1
In a 12-month Phase III clinical study approximately 38% of patients treated with LUMIGAN® 0.1 mg/ml eye drops, solution experienced adverse reactions. The most frequently reported adverse reaction was conjunctival hyperaemia (mostly trace to mild and of a non-inflammatory nature) occurring in 29% of patients. Approximately 4% of patients discontinued due to any adverse event in the 12-month study.1
Please refer to LUMIGAN® 0.01% Summary of Product Characteristics for further information on adverse events.