ALPHAGAN® P 0.1% or 0.15% offers an established safety profile1
ALPHAGAN® P 0.1% or 0.15% is indicated for the reduction of elevated intraocular pressure (IOP) in patients with open angle glaucoma or ocular hypertension.1
ALPHAGAN® 0.2% (brimonidine ophthalmic solution)
Adverse reactions associated with ALPHAGAN® P 0.1% or 0.15% as listed in the prescribing information*,1
| Frequency | Adverse reaction |
| 10–20% of subjects | allergic conjunctivitis, conjunctival hyperemia, eye pruritus |
| 5–9% of subjects | burning sensation, conjunctival folliculosis, hypertension, ocular allergic reaction, oral dryness, and visual disturbance |
| 1–4% of subjects | abnormal taste, allergic reaction, asthenia, blepharitis, blepharoconjunctivitis, blurred vision, bronchitis, cataract, conjunctival edema, conjunctival hemorrhage, conjunctivitis, cough, dizziness, dyspepsia, dyspnea, epiphora, eye discharge, eye dryness, eye irritation, eye pain, eyelid edema, eyelid erythema, fatigue, flu syndrome, follicular conjunctivitis, foreign body sensation, gastrointestinal disorder, headache, hypercholesterolemia, hypotension, infection (primarily colds and respiratory infections), insomnia, keratitis, lid disorder, pharyngitis, photophobia, rash, rhinitis, sinus infection, sinusitis, somnolence, stinging, superficial punctate keratopathy, tearing, visual field defect, vitreous detachment, vitreous disorder, vitreous floaters, and worsened visual acuity |
| Less than 1% of subjects | corneal erosion, hordeolum, nasal dryness, and taste perversion |
Adapted from ALPHAGAN® P 0.1% or 0.15% Prescribing Information. 2013.1
*Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.1
Please refer to the Prescribing Information for further details of adverse events associated with ALPHAGAN® P 0.1% or 0.15%.
ALPHAGAN® P 0.1% or 0.15% as a monotherapy could offer your patients with OAG or OHT an established safety profile1
Lower concentrations of brimonidine in ALPHAGAN® P 0.1% and the use of Purite® as a preservative, rather than BAK, could offer a more favorable safety and tolerability profile than the original formulation, ALPHAGAN® 0.2% in irritated eyes.2
When administered into the eye, Purite® is converted into natural tear components, such as sodium and chloride ions, oxygen, and water.3
A meta-analysis of safety and tolerability results found a significantly lower incidence of treatment-related adverse events and discontinuation in patients treated with ALPHAGAN® P 0.15% (n=215) vs. ALPHAGAN® 0.2% (n=218), p≤0.014.*,4
ALPHAGAN® P 0.15% could offer a more favorable safety and tolerability profile and better satisfaction and comfort compared to ALPHAGAN® P 0.2% and ALPHAGAN® 0.2%.5
In a 12-month RCT, there were fewer treatment-related adverse events reported by patients treated with ALPHAGAN® P 0.15% (n=129/381; 33.9%) vs. either ALPHAGAN® P 0.2% (n=180/383; 47.0%) or ALPHAGAN® 0.2% (n=213/383; 55.6%).**,5
In the same trial, there were also significantly lower incidences of conjunctival hyperemia, allergic conjunctivitis, and oral dryness in patients treated with ALPHAGAN® P 0.15% (n=124/381; 32.5%) vs. ALPHAGAN® P 0.2% (n=173/383; 45.2%) and ALPHAGAN® 0.2% (n=198/383; 51.7%), p≤0.013.**,5
*Results of a meta-analysis of safety and tolerability results from 2 previously reported prospective, randomized, 12-month, double-masked, multicenter, parallel-group clinical studies of thrice-daily ALPHAGAN® P 0.1% or 0.15% with similar entry criteria and protocols. One study was a pooled analysis of 2 identical non-inferiority trials where patients received thrice-daily treatment with ALPHAGAN® P 0.15% (n=381), ALPHAGAN® P 0.2% (n=383), or ALPHAGAN® 0.2% (n=383), while the other was an equivalence study where the treatment arms were thrice-daily ALPHAGAN® P 0.1% (n=215) and ALPHAGAN® 0.2% (n=218). ALPHAGAN® P 0.1%/0.15% are both approved with thrice-daily dosing in the United States.4
**Results of a 12-month, randomized, multicenter, double-masked, parallel-group study comparing the efficacy and safety of thrice-daily ALPHAGAN® P 0.15% and 0.2% with thrice-daily ALPHAGAN® 0.2% in patients with glaucoma or OHT, (N=1,147).5
[The above studies may be off label in some markets as ALPHAGAN® 0.2% is used thrice daily – markets to amend accordingly]
Although ALPHAGAN® P 0.1% or 0.15% had minimal effect on the blood pressure of patients in clinical studies, caution should be exercised in treating patients with severe cardiovascular disease.1
ALPHAGAN® P 0.1% or 0.15% as an adjunctive therapy could offer your patients with OAG or OHT an established safety profile1
A study showed patients treated with ALPHAGAN® P 0.1% adjunctive to latanoprost 0.005% (n=20) were significantly less likely to report an unusual taste associated with eye drop installation at 3 months (n=2/20) vs. patients treated with adjunctive brinzolamide (n=7/20), p≤0.031.†,6
They were also significantly less likely to report changes in vision (usually described as blurred vision) at month 1 (n=2/20) vs. patients treated with adjunctive brinzolamide (n=8/20), p=0.11.†,6
These are reflective of survey-reported data and there were no significant differences between the two groups with regards to treatment-related adverse events.6
*Results of a 3-month randomized, single-center, investigator-masked, parallel-group clinical study evaluating the efficacy and tolerability of thrice-daily ALPHAGAN® P 0.1% (n=20) in comparison to thrice-daily brinzolamide 0.1% (n=20) when used as adjunctive therapy to once-daily latanoprost 0.005% in patients with glaucoma or OHT. A written questionnaire was administered at each follow-up visit to evaluate the comfort and tolerability of study drug instillation. Patients were asked to respond ‘yes’, ‘no’, or ‘not sure’ to the following questions: (1) Did you have any unusual taste after taking the eye drop medication? (2) Did you experience any unusual sensation in your eye after taking the eye drop medication? (3) Did you experience any discomfort in your eye after taking the eye drop medication? (4) Did you experience any change in vision after instilling the eye drop medication? Patients who responded ‘yes’ or ‘not sure’ were asked how much the taste, sensation, discomfort, or vision change bothered them and whether it caused them to want to discontinue the study medication. Additional studies are needed as this study was limited by its small sample size and single site location.6
Please refer to ALPHAGAN® P 0.1% or 0.15% Summary of Product Characteristics for further adverse event and safety information.
ALPHAGAN® P 0.1% or 0.15% is indicated for the reduction of elevated intraocular pressure (IOP) in patients with open angle glaucoma or ocular hypertension.1
Most common adverse reactions occurring in approximately 5% to 20% of patients receiving brimonidine ophthalmic solution (0.1%–0.2%) included allergic conjunctivitis, burning sensation, conjunctival folliculosis, conjunctival hyperemia, eye pruritus, hypertension, ocular allergic reaction, oral dryness, and visual disturbance.1
ADR, adverse drug reaction; BAK, benzalkonium chloride; CI, confidence interval; HR; hazard ratio; IOP, intraocular pressure; PGA, prostaglandin analog; OAG, open-angle glaucoma; OHT, ocular hypertension; RCT, randomized controlled trial.
1. ALPHAGAN® P (brimonidine tartrate ophthalmic solution) 0.1% or 0.15%. Prescribing Information. 2013.
2. Mundorf T et al. Adv in Ther 2003; 20(6): 329–336.
3. Noecker R. Adv Ther 2001; 18(5) 205–209.
4. Cantor L et al. Curr Med Res and Opin 2009; 25(7): 1615–1620.
5. Katz L. Journal of Glaucoma 2002; 11: 119–126.
6. Day D and Hollander D. Curr Med Res Opin 2008; 24(5): 1435–1442.