PHARMACEUTICAL
Glaucoma
ROCKLATAN®
SIMBRINZA®
RHOPRESSA®
Congress Posters & Presentations
POSTER
Effects of Switching Patients with Uncontrolled IOP on Latanoprost Monotherapy to Netarsudil 0.02%/Latanoprost 0.005% Fixed Dose Combination
POSTER
Efficacy of Netarsudil 0.02% in Lowering Intraocular Pressure in Black Patients: Post Hoc Analysis of Pooled Phase 3 ROCKET Studies
POSTER
Efficacy of Netarsudil 0.02% Monotherapy and Netarsudil/Latanoprost 0.02%/0.005% Fixed Dose Combination in Lowering Intraocular Pressure in Black Patients: Post Hoc Analysis of Phase 3 MERCURY Data
PRESENTATION
Overview of Switching from Latanoprost Alone or Adjunctive Therapy to Netarsudil/Latanoprost Fixed-Dose Combination for More IOP Lowering
PRESENTATION
The Impact of Switching Patients on Latanoprost Monotherapy to Netarsudil/Latanoprost Fixed-Dose Combination for Additional IOP Reduction
PRESENTATION
Patient-Reported Outcomes and Investigator Impressions After Switching to Netarsudil/Latanoprost Fixed-Dose Combination Therapy
POSTER
Overview of Switching from Latanoprost Regimens to Netarsudil/Latanoprost Fixed-Dose Combination for More IOP Lowering
PRESENTATION
Consolidating Drops: Switching From Latanoprost-Based Adjunctive Therapies to Netarsudil/Latanoprost Fixed-Dose Combination to Lower IOP
Clinical Trials
Two Phase 3 Clinical Trials Comparing the Safety and Efficacy of Netarsudil to Timolol in Patients With Elevated Intraocular Pressure
Long-term Safety and Ocular Hypotensive Efficacy Evaluation of Netarsudil Ophthalmic Solution Rho Kinase Elevated IOP Treatment Trial
Once-Daily Netarsudil Versus Twice-Daily Timolol in Patients With Elevated Intraocular Pressure Randomized Phase 3 ROCKET 4 Study
Once-Daily Netarsudil-Latanoprost Fixed-Dose Combination for Elevated Intraocular Pressure in the Randomized Phase 3 MERCURY-2 Study
Netarsudil-Latanoprost Fixed-Dose Combination for Elevated Intraocular Pressure: Three-Month Data from a Randomized Phase 3 Trial
Three-Month Randomized Trial of Fixed-Combination Brinzolamide, 1%, and Brimonidine, 0.2%
Phase 3 Randomized 3-Month Trial with an Ongoing 3-Month Safety Extension of Fixed Combination Brinzolamide 1%/Brimonidine, 0.2%
ROCKLATAN® contains latanoprost, which may cause darkening of the eye color, darkening of the eyelid and eyelashes, and increased growth and thickness of eyelashes. Color changes may increase as long as ROCKLATAN® is administered, and eye color changes are likely to be permanent. Eyelash and eyelid changes are usually reversible upon discontinuation of treatment.
- Avoid allowing the tip of the bottle to contact the eye, surrounding structures, fingers, or any other surface in order to minimize contamination of the solution. Serious damage to the eye and subsequent loss of vision may result from using contaminated solution.
- If you develop another ocular condition (e.g., trauma or infection), have ocular surgery, or develop any ocular side effects, particularly conjunctivitis and eyelid reactions, you should immediately seek your healthcare provider’s advice about continuing to use ROCKLATAN®.
- The preservative in ROCKLATAN®, benzalkonium chloride, may be absorbed by soft contact lenses. Contact lenses should be removed prior to instillation of ROCKLATAN®, but may be reinserted 15 minutes after instillation.
- If you are using more than one eyedrop, the drugs should be administered at least 5 minutes apart.
- The most common side effect of ROCKLATAN® in clinical trials was red eyes (59% of patients). Five percent of patients stopped taking ROCKLATAN® due to red eyes. Other common side effects were: instillation site pain (20%), small deposits on the outer surface of the eye (15%), and broken blood vessels on the white of the eye (11%).
Contraindications
SIMBRINZA® is contraindicated in patients who are hypersensitive to any component of this product and neonates and infants under the age of 2 years.
INDICATIONS AND USAGE
SIMBRINZA® (brinzolamide/brimonidine tartrate ophthalmic suspension) 1%/0.2% is a fixed combination indicated in the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.
WARNINGS/PRECAUTIONS
Sulfonamide Hypersensitivity Reactions—Brinzolamide is a sulfonamide, and although administered topically, is absorbed systemically. Sulfonamide attributable adverse reactions may occur. Fatalities have occurred due to severe reactions to sulfonamides. Sensitization may recur when a sulfonamide is readministered irrespective of the route of administration. If signs of serious reactions or hypersensitivity occur, discontinue the use of this preparation immediately.
Corneal Endothelium—There is an increased potential for developing corneal edema in patients with low endothelial cell counts. Caution should be used when prescribing SIMBRINZA to these patients.
Severe Renal Impairment (CrCl <30 mL/min)—SIMBRINZA has not been specifically studied and since brinzolamide and its metabolite are excreted primarily by the kidney, is not recommended in these patients.
Acute Angle-Closure Glaucoma—The management of patients with acute angle-closure glaucoma requires therapeutic interventions in addition to ocular hypotensive agents. SIMBRINZA has not been studied in these patients.
Contact Lens Wear—The preservative in SIMBRINZA, benzalkonium chloride, may be absorbed by soft contact lenses. Contact lenses should be removed during instillation of SIMBRINZA but may be reinserted 15 minutes after instillation.
Severe Cardiovascular Disease—Brimonidine tartrate, a component of SIMBRINZA, had a less than 5% mean decrease in blood pressure 2 hours after dosing in clinical studies; caution should be exercised in treating patients with severe cardiovascular disease.
Potentiation of Vascular Insufficiency—Brimonidine tartrate, a component of SIMBRINZA, may potentiate syndromes associated with vascular insufficiency. It should be used with caution in patients with depression, cerebral or coronary insufficiency, Raynaud’s phenomenon, orthostatic hypotension, or thromboangiitis obliterans.
Contamination of Topical Ophthalmic Products After Use—There have been reports of bacterial keratitis associated with the use of multiple-dose containers of topical ophthalmic products. These containers have been inadvertently contaminated by patients who, in most cases, had a concurrent corneal disease or a disruption of the ocular epithelial surface.
Adverse Reactions
SIMBRINZA® Suspension
In two clinical trials of 3 months’ duration with SIMBRINZA, the most frequent reactions associated with its use occurring in approximately 3-5% of patients in descending order of incidence included: blurred vision, eye irritation, dysgeusia (bad taste), dry mouth, and eye allergy. Adverse reaction rates with SIMBRINZA were comparable to those of the individual components. Treatment discontinuation, mainly due to adverse reactions, was reported in 11% of SIMBRINZA patients.
Brinzolamide 1%
In clinical studies of brinzolamide ophthalmic suspension 1%, the most frequently reported adverse events reported in 5-10% of patients were blurred vision and bitter, sour, or unusual taste.
Brimonidine Tartrate 0.2%
In clinical studies of brimonidine tartrate 0.2%, adverse events occurring in approximately 10-30% of the subjects, in descending order of incidence, included oral dryness, ocular hyperemia, burning and stinging, headache, blurring, foreign body sensation, fatigue/drowsiness, conjunctival follicles, ocular allergic reactions, and ocular pruritus.
Drug Interactions
Concomitant administration with oral carbonic anhydrase inhibitors is not recommended due to the potential additive effect. Use with high-dose salicylate may result in acid-base and electrolyte alterations. The possibility of an additive or potentiating effect with CNS depressants should be considered. Because brimonidine tartrate may reduce blood pressure, caution in using antihypertensives and/or cardiac glycosides with SIMBRINZA is advised. Use of tricyclic antidepressants may blunt the hypotensive effect of systemic clonidine and it is unknown if use of this class of drugs with SIMBRINZA interferes with IOP lowering. Use with monoamine oxidase inhibitors may result in increased systemic side effects, such as hypotension.
- Avoid allowing the tip of the bottle to contact the eye, surrounding structures, fingers, or any other surface in order to minimize contamination of the solution. Serious damage to the eye and subsequent loss of vision may result from using contaminated solution.
- If you develop another ocular condition (e.g., trauma or infection), have ocular surgery, or develop any ocular side effects, particularly conjunctivitis and eyelid reactions, you should immediately seek your healthcare provider’s advice about continuing to use RHOPRESSA®.
- The preservative in RHOPRESSA®, benzalkonium chloride, may be absorbed by soft contact lenses. Contact lenses should be removed prior to instillation of RHOPRESSA®, but may be reinserted 15 minutes after instillation.
- If you are using more than one eyedrop, the drugs should be administered at least 5 minutes apart.
- The most common side effect of RHOPRESSA® in clinical trials was red eyes (53% of patients). Six percent of patients stopped taking RHOPRESSA® due to red eyes. Other common (approximately 20%) side effects were: small deposits on the outer surface of the eye, instillation site pain, and broken blood vessels on the white of the eye.