Sandoz launches generic brimonidine tartrate/timolol – Tips & Results

  • Brimonidine tartrate/timolol maleate combination eye drops are used to treat increased pressure in the eye 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 highly effective medicines that bring savings to US patients and support the sustainability of the entire US healthcare system

Basel, April 14, 2022 — Sandoz, a global leader in generics and biosimilars, announced today the launch in the United States of its generic eye drop combination brimonidine tartrate/timolol maleate eye drop 0.2%/0.5% eye drop, an AB-rated generic drug conforming to the COMBIGAN by AbbVie corresponds®* to lower intraocular pressure in patients with ocular hypertension (high pressure inside the eye).1 These prescription eye drops are now available to patients through pharmacies.

Anyone can develop ocular hypertension, but certain groups are at higher risk, including but not limited to African Americans and Hispanics, people over 40, people with diabetes or high blood pressure, people with severe nearsightedness (myopia), and people who take steroid drugs for a long time take period.4 It’s important to treat high eye pressure before it damages the optic nerve and causes vision loss.5

“Fixed combinations of drugs to treat ocular hypertension can provide patients with greater convenience, improved adherence, reduced exposure to preservatives, and cost savings,” said Keren Haruvi, President of Sandoz Inc. “We developed this important generic ophthalmic drug in-house to to expand patient access to quality, more affordable eye care for millions of patients in the United States.”

Sandoz is a leading US provider of eye care products with more than 36 families of products to treat a broad spectrum of eye disorders. The launch of generic brimonidine tartrate/timolol maleate combination eye drops in the US expands Sandoz’s ophthalmic portfolio and helps maintain its position as the #1 generic ophthalmology market in the US.6

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

important safety instructions

contraindications

  • Bronchial asthma, a history of bronchial asthma, severe chronic obstructive pulmonary disease.
  • Sinus bradycardia, atrioventricular block, overt heart failure, cardiogenic shock.
  • Newborns and infants (less than 2 years old).
  • Hypersensitivity to any component of this product.

Warnings and Precautions

  • Potential for severe respiratory or cardiac reactions
  • heart failure
  • obstructive pulmonary disease
  • Potentiation of vascular insufficiency
  • Increased reactivity to allergens
  • potentiation of muscle weakness
  • Masking hypoglycemic symptoms in patients with diabetes
  • Mellitus
  • Masking of thyrotoxicosis
  • eye hypersensitivity

side effects

The most common side effects, occurring in approximately 5 to 15% of patients, included allergic conjunctivitis, conjunctival folliculosis, conjunctival hyperaemia, eye itching, eye burning and stinging.

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

Interactions with other drugs

  • Antihypertensives/cardiac glycosides can lower blood pressure.
  • Concomitant use with systemic beta-blockers may potentiate systemic beta-blockade.
  • Oral or intravenous calcium channel blockers can cause atrioventricular conduction abnormalities, left ventricular failure, and hypotension.
  • Drugs that deplete catecholamines can have additive effects, resulting in hypotension and/or marked bradycardia.
  • Use with CNS depressants may result in an additive or potentiating effect.
  • Digitalis and calcium channel blockers may have additive effects in increasing atrioventricular conduction time.
  • CYP2D6 inhibitors may potentiate systemic beta-blockade.
  • Tricyclic antidepressants may reduce the antihypertensive effect of systemic clonidine.
  • Monoamine oxidase inhibitors can lead to increased hypotension.

Use in specific populations

Not for use in children under 2 years of age. Use with caution in children ≥2 years.

please see Full Prescribing Information for additional security information.

indication and use

Brimonidine tartrate and timolol maleate ophthalmic solution, 0.2%/0.5% is an alpha-adrenergic receptor agonist with a beta-adrenergic receptor inhibitor indicated for the reduction of elevated intraocular pressure (IOP) in patients with ocular hypertension due to of insufficient response requiring adjunctive or replacement therapy controlled IOP; the IOP reduction of brimonidine tartrate and timolol maleate eye drops 0.2%/0.5% twice daily administered was slightly less than with the concomitant use of timolol maleate eye drops 0.5% twice daily and brimonidine tartrate eye drops, 0.2% dosed three times a 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 are generally qualified by terms such as “potential”, “may”, “will”, “plan”, ” “may”, “could” , “would”, “expect”, “anticipate”, “anticipate”, “believe”, “committed”, “investigative”, “pipeline”, “launch” or similar terms, or by express or implied discussions of potential market approvals, new indications or designations for the investigational or approved products described in this press release, or potential future revenue from such products. You should not place undue reliance on these statements. Such forward-looking statements are based on our current beliefs and expectations regarding future events and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those projected in the forward-looking statements. There can be no assurance that the investigational or approved products described in this press release will be submitted or approved for sale or for additional indications or labeling in any market or at any particular time. There is also no guarantee that such generics or biosimilars, if approved, will be approved for all indications listed on the label of the reference product. Nor can there be any guarantee that such products will be commercially successful in the future. In particular, our expectations regarding such products could be affected by, among other things, the uncertainties inherent in research and development, including the results of clinical trials and additional analysis of existing clinical data; government actions or delays or government regulation generally; the particular prescribing preferences of physicians and patients; competition generally, including the potential approval of additional generic or biosimilar versions of such products; global trends in healthcare cost containment, including pricing and reimbursement pressures from governments, payers and the general public and calls for increased pricing transparency; outcomes of litigation, including intellectual property disputes or other legal efforts to prevent or restrict Sandoz from selling its products; general political, economic and business conditions, including the impact of and efforts to contain pandemic diseases such as COVID-19; security, quality, data integrity or manufacturing issues; potential or actual data security and privacy breaches or disruptions to our information technology systems; and other risks and factors referred to on Novartis AG’s most recent Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and undertakes no obligation to update any forward-looking statements contained in this press release, whether as a result of new information, future events or otherwise.

About Sandoz
Sandoz, a division of Novartis, is a global leader in generics and biosimilars. Our goal is to advance patient access by developing and commercializing novel, affordable approaches that address unmet medical needs. Our goal is to be the world’s leading and most respected generic drug company. Our broad portfolio of high-quality medicines, covering all major therapeutic areas, generated sales of US$9.6 billion in 2021.

Sandoz on social media:
LinkedIn: https://www.linkedin.com/company/sandoz
Twitter: https://twitter.com/sandoz_global
Facebook: https://www.facebook.com/sandozglobal/
Instagram: https://www.instagram.com/sandozglobal

CEO Richard Saynor on LinkedIn: https://www.linkedin.com/in/richard-saynor/

references

  1. 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 April 12, 2022.
  2. Lazarus R. Ocular hypertension. optometrist network. https://www.optometrists.org/general-practice-optometry/guide-to-eye-conditions/glaucoma-guide/glaucoma/ocular-hypertension/. Published July 4, 2021. Accessed January 20, 2022.
  3. 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.
  4. Boyd K. Causes of ocular hypertension. American Academy of Ophthalmology. https://www.aao.org/eye-health/diseases/ocular-hypertension-cause. Published March 9, 2021. Accessed January 21, 2022.
  5. Boyd K. Diagnosis and management of ocular hypertension. American Academy of Ophthalmology. https://www.aao.org/eye-health/diseases/ocular-hypertension-treatment. Published March 9, 2021. Accessed January 21, 2022.
  6. Generic Prescription Ophthalmology Market in revenue and volume measurements. IQVIA MAT. Late November 2021. Accessed January 19, 2022.

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