Brimonidine tartrate/timolol maleate combination eyedrop is used to treat elevated eye pressure in patients with ocular hypertension1
Ocular hypertension affects over 5% of all adults2; the eye does not properly drain fluid, causing eye pressure to build up3

Sandoz manufactures high-impact medicines that bring savings to US patients and support the sustainability of the overall US healthcare system
Basel, April 14, 2022 — Sandoz, a global leader in generic and biosimilar medicines, today announced the US launch of its generic combination eyedrop brimonidine tartrate/timolol maleate ophthalmic solution 0.2%/0.5%, an AB-rated generic equivalent to AbbVie’s COMBIGAN®*, to lower eye pressure in patients with ocular hypertension (high eye pressure).1 This prescription eyedrop is immediately available to patients via retail pharmacies.

Anyone can develop ocular hypertension, but certain groups are at higher risk, including but not limited to African Americans and Hispanics, people over age 40, people living with diabetes or high blood pressure, people who are very myopic (near-sighted) and people who take long-term steroid medicines.4 It is important to treat high eye pressure before it causes damage to the optic nerve and vision loss.5

“Fixed combinations of medicines to treat ocular hypertension can offer patients enhanced convenience, improved adherence, reduced exposure to preservatives, and cost savings,” said Keren Haruvi, President, Sandoz Inc. “We developed this important generic eye treatment in-house to expand patient access to high-quality, more affordable eye care for millions of US patients.”

Sandoz is a leading provider of ophthalmic medicines in the US, with over 36 product families for the treatment of a wide range of eye diseases. The launch of generic brimonidine tartrate/timolol maleate combination eyedrops in the US expands the Sandoz ophthalmology portfolio, helping maintain its #1 position in the US generic ophthalmic space.6

* COMBIGAN® and its design are registered trademarks of Allergan, Inc., an AbbVie company.

Important Safety Information

Contraindications

Bronchial asthma, a history of bronchial asthma, severe chronic obstructive pulmonary disease.
Sinus bradycardia, atrioventricular block, overt cardiac failure, cardiogenic shock.
Neonates and infants (under the age of 2 years).
Hypersensitivity to any component of this product.
Warnings and Precautions

Potential for Severe Respiratory or Cardiac Reactions
Cardiac Failure
Obstructive Pulmonary Disease
Potentiation of Vascular Insufficiency
Increased Reactivity to Allergens
Potentiation of Muscle Weakness
Masking of Hypoglycemic Symptoms in Patients with Diabetes
Mellitus
Masking of Thyrotoxicosis
Ocular Hypersensitivity
Adverse Reactions

Most common adverse reactions occurring in approximately 5 to 15% of patients included allergic conjunctivitis, conjunctival folliculosis, conjunctival hyperemia, eye pruritus, ocular burning, and stinging.

To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Drug Interactions

Antihypertensives/cardiac glycosides may lower blood pressure.
Concomitant use with systemic beta-blockers may potentiate systemic beta-blockade.
Oral or intravenous calcium antagonists may cause atrioventricular conduction disturbances, left ventricular failure, and hypotension.
Catecholamine-depleting drugs may have additive effects and produce hypotension and/or marked bradycardia.
Use with CNS depressants may result in an additive or potentiating effect.
Digitalis and calcium antagonists may have additive effects in prolonging atrioventricular conduction time.
CYP2D6 inhibitors may potentiate systemic beta-blockade.
Tricyclic antidepressants may potentially blunt the hypotensive effect of systemic clonidine.
Monoamine oxidase inhibitors may result in increased hypotension.
Use in Specific Populations

Not for use in children below the age of 2 years. Use with caution in children ?2 years of age.

Please see Full Prescribing Information for additional safety information.

Indication and Usage

Brimonidine tartrate and timolol maleate ophthalmic solution, 0.2%/0.5% is an alpha-adrenergic receptor agonist with a betaadrenergic receptor inhibitor indicated for the reduction of elevated intraocular pressure (IOP) in patients with ocular hypertension who require adjunctive or replacement therapy due to inadequately controlled IOP; the IOP-lowering of brimonidine tartrate and timolol maleate ophthalmic solution, 0.2%/0.5% dosed twice a day was slightly less than that seen with the concomitant administration of timolol maleate ophthalmic solution, 0.5% dosed twice a day and brimonidine tartrate ophthalmic solution, 0.2% dosed three times per day.

Disclaimer
This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as “potential,” “can,” “will,” “plan,” “may,” “could,” “would,” “expect,” “anticipate,” etc. etc..

References

Brimonidine tartrate/timolol maleate solution/drops. Prescribing information. Available at: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=af21d2e5-0029-4889-ba93-6417baa91ce6. Accessed on April 12, 2022.
Lazarus R. Ocular Hypertension. Optometrists Network. https://www.optometrists.org/general-practice-optometry/guide-to-eye-conditions/glaucoma-guide/glaucoma/ocular-hypertension/. Published July 4, 2021. Accessed on January 20, 2022.
Boyd K. What Is Ocular Hypertension? American Academy of Ophthalmology. https://www.aao.org/eye-health/diseases/what-is-ocular-hypertension. Published March 9, 2021. Accessed January 21, 2022.
Boyd K. Ocular Hypertension Causes. American Academy of Ophthalmology. https://www.aao.org/eye-health/diseases/ocular-hypertension-cause. Published March 9, 2021. Accessed January 21, 2022.
Boyd K. Ocular Hypertension Diagnosis and Treatment. American Academy of Ophthalmology. https://www.aao.org/eye-health/diseases/ocular-hypertension-treatment. Published March 9, 2021. Accessed January 21, 2022.
Generic Prescription Ophthalmology Market in Sales and Volume Measures. IQVIA MAT. Ending November 2021. Accessed on January 19, 2022.
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