Sandoz Launches Generic Version of Treatment for Ocular Hypertension

Sandoz has announced the US market 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, which reduces eye pressure in patients with ocular hypertension (high eye pressure).

The generic prescription eyedrop will be immediately available to patients at retail pharmacies.

“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, in a press release. “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.”

Although ocular hypertension can strike any patient population, certain groups have a higher risk, including but not limited to African Americans and Hispanics, individuals over 40 years of age, patients with diabetes or high blood pressure, individuals who are myopic, and individuals prescribed long-term steroid medications. If left untreated, high eye pressure can damage the optic nerve and cause vision loss.

Brimonidine tartrate and timolol maleate ophthalmic solution, 0.2%/0.5% is an alpha-adrenergic receptor agonist with a betaadrenergic receptor inhibitor indicated to lower elevated intraocular pressure (IOP) in individuals with ocular hypertension who need adjunctive or replacement therapy because of inadequately controlled IOP.

IOP-lowering of brimonidine tartrate and timolol maleate ophthalmic solution, 0.2%/0.5% at a twice daily dose was slightly lower than what was observed with the concomitant administration of timolol maleate ophthalmic solution, 0.5% dosed twice a day and brimonidine tartrate ophthalmic solution, 0.2% 3 times per day, according to Sandoz.

The generic Combigan is contraindicated for patients with bronchial asthma, a history of bronchial asthma, and severe chronic obstructive pulmonary disease; sinus bradycardia, atrioventricular block, overt cardiac failure, and cardiogenic shock; neonates and those under 2 years of age; and hypersensitivity to any component of the drug.

Warnings and precautions for the drug include potential for severe respiratory or cardiac reactions; cardiac failure; chronic obstructive pulmonary disease; potentiation of vascular insufficiency; increased reactivity to allergens; potentiation of muscle weakness; masking of hypoglycemic symptoms in patients with diabetesmellitus; masking of thyrotoxicosis; and ocular hypersensitivity.

The most common adverse events with the drug occurring in approximately 5% to 15% of patients included allergic conjunctivitis, conjunctival folliculosis, conjunctival hyperemia, eye pruritus, ocular burning, and stinging. The drug is not for use in children under 2 years of age.

Reference

Sandoz launches generic brimonidine tartrate/timolol maleate eyedrop in US for patients with ocular hypertension, expanding leading ophthalmic portfolio. Sandoz. News release. April 14, 2022. https://www.novartis.com/news/media-releases/sandoz-launches-generic-brimonidine-tartratetimolol-maleate-eyedrop-us-patients-ocular-hypertension-expanding-leading-ophthalmic-portfolio