Brimonidine tartrate ophthalmic solution 0.1% is now available in the United States, according to Apotex Corp.
Refresh me on this company first.
Headquartered in Weston, Florida, Apotex Corp. is the U.S. arm of Apotex Inc., a Canadian global pharmaceutical company focused on producing high-quality, affordable generic medications covering major therapeutic areas, including glaucoma.
Wait … wasn’t this product already recalled?
Nope! You’re thinking of the company’s brimonidine tartrate ophthalmic solution 0.15% (note the difference), which is also indicated for IOP reduction in open-angle glaucoma (OAG) and ocular hypertension(OHT) patients.
Why was it recalled?
The company voluntarily recalled that product in March 2023 due to reports of cracks in six lots of the solution that developed in some of the units’ caps on the bottles—which could impact sterility and, potentially, cause adverse events (AEs) for consumers.Read our coverage here.
Gotcha. Now talk about this drug.
Brimonidine tartrate ophthalmic solution 0.1% is an alpha-adrenergic receptor agonist that is indicated for reducing intraocular pressure (IOP) in patients with OAG or OHT.
Talk about brimonidine tartrate.
The solution has a peak ocular hypotensive effect that can occur 2 hours after dosing.
It has also been clinically shown to have a dual mechanism of action by reducing aqueous humor production while increasing uveoscleral outflow.
And the recommended dosage?
Per the drug’s prescribing information, one drop is intended to be administered into the affected eye(s) three times a day (TID), approximately 8 hours apart.
What’s the clinical data on it?
A clinical study comparing the use of brimonidine tartrate ophthalmic solution 0.1% against brimonidine tartrate ophthalmic solution 0.2% found that 0.1% can be considered equivalent in lowering IOP to that of 0.2%, according to the prescribing info.
Further, it was found to effectively lower IOP for both OAG and OHT patients by an estimated 2 to 6 mmHg.
Lastly … where can I purchase this?
Apotex Corp. has not yet released details on where brimonidine tartrate ophthalmic solution 0.1% is commercially available yet… so stay tuned!