COMBIGAN® (brimonidine 0.2%/timolol 0.5%)
COMBIGAN® is indicated for the reduction of intraocular pressure (IOP) in patients with chronic open-angle glaucoma or ocular hypertension who are insufficiently responsive to topical β-blockers.1
COMBIGAN® UD (brimonidine 0.2%/timolol 0.5%)
COMBIGAN® has demonstrated a well-established safety profile1
Based on 12-month clinical data, the most commonly reported ADRs were conjunctival hyperemia (approximately 15% of patients) and burning sensation in the eye (approximately 11% of patients). The majority of these cases was mild and led to discontinuation rates of only 3.4% and 0.5% respectively.1
Please refer to COMBIGAN® Summary of Product Characteristics for further information on adverse events.
Very common and common AEs associated with COMBIGAN® in clinical studies1
| System Organ class | Frequency | Adverse reaction |
|---|---|---|
| Eye disorders | Very common
| Conjunctival hyperemia, burning sensation |
| Common | Stinging sensation in the eye, allergic conjunctivitis, corneal erosion, superficial punctuate keratitis, eye pruritus, conjunctival folliculosis, visual disturbance, blepharitis, epiphora, eye dryness, eye discharge, eye pain, eye irritation, foreign body sensation | |
| Psychiatric disorders | Common | Depression |
| Nervous system disorders | Common | Somnolence, headache |
Vascular disorders | Common | Hypertension |
Gastrointestinal disorders | Common | Oral dryness |
Skin and subcutaneous tissue disorders | Common | Eyelid edema, eyelid pruritus, eyelid erythema |
General disorders and administration site conditions | Common | Asthenic conditions |
Adapted from COMBIGAN® Summary of Product Characteristics. 2022.1
In a clinical trial, patients treated with twice-daily COMBIGAN® (n=34 eyes of 18 patients) experienced fewer events of conjunctival hyperemia than patients treated with twice-daily fixed-combination dorzolamide 2%/timolol 0.5% (n=34 eyes of 20 patients) at 5 minutes (0.06±0.14 vs. 0.29±0.21) and 2 months (0.12±0.15 vs. 0.56±0.61) post-administration (p=0.032 for both).*,2
In the same trial, patients treated with twice-daily COMBIGAN® (n=34 eyes of 18 patients) experienced fewer events of conjunctival hyperemia than once-daily fixed-combination latanoprost 0.005%/timolol 0.5% (n=38 eyes of 20 patients) at 5 minutes (0.06±0.14 vs. 0.79±0.71; p=0.017) and 2 months (0.12±0.15 vs. 1.0±1.02; p<0.001) post administration. Patients in the COMBIGAN® group experienced more burning/stinging than patients in the fixed-combination latanoprost 0.005%/timolol 0.5% group at 5 minutes (0.94±0.73 vs. 0.53±0.34; p=0.044) post administration.*,2
* Results of a prospective clinical trial in which patients with POAG were randomized to receive 1 of the following treatment sequences: twice-daily COMBIGAN®, twice-daily fixed-combination dorzolamide 2%/timolol 0.5%, and once-daily fixed-combination latanoprost 0.005% and timolol 0.5%, (N=106 eyes of 58 patients).2
Please refer to COMBIGAN® Summary of Product Characteristics for further information on adverse events.
Reporting of suspected adverse reactions
COMBIGAN® is indicated for the reduction of intraocular pressure (IOP) in patients with chronic open-angle glaucoma or ocular hypertension who are insufficiently responsive to topical beta-blockers.1
Based on 12-month clinical data, the most commonly reported ADRs were conjunctival hyperemia (approximately 15% of patients) and burning sensation in the eye (approximately 11% of patients). The majority of these cases was mild and led to discontinuation rates of only 3.4% and 0.5% respectively.1
Please refer to COMBIGAN® Summary of Product Characteristics for further information on adverse events.
ADR, adverse drug reaction; AE, adverse event; IOP, intraocular pressure; OHT, ocular hypertension; PGA, prostaglandin analog; POAG, primary open-angled glaucoma.
- COMBIGAN® (brimonidine 0.2%/timolol 0.5%). Summary of Product Characteristics. 2022.
- Ozer M et al. Int J Ophthalmol 2014; 7(5): 832–836.