Gland Pharma Limited has reportedly received tentative FDA approval for brimonidine tartrate ophthalmic solution 0.025%, indicated for the treatment of redness in the eye.
The formulation is intended as a generic form of Bausch + Lomb Corporation’s LUMIFY redness reliever drops.
Do we need a refresh on Gland Pharma?
If you do, see here for a look at the India-based small-molecule, generic injectables manufacturing company.
And in recent news: Gland also received FDA approval for another generic earlier this year: Olopatadine hydrochloride (HCl) ophthalmic solution USP, 0.7%—a generic equivalent to Alcon, Inc.’s Pataday Once Daily Extra Strength eye drops.
Nice! Now to this latest generic.
Brimonidine tartrate ophthalmic solution 0.025% is an over-the-counter (OTC) eye drop indicated for the relief of redness of the eye.
Its generic status: Granted based on its formulation containing the exact same active ingredient as the brand-name drug (also known as its reference-listed drug [RLD]), as well as the same strength, quality, and effectiveness.
... and what does this tentative approval mean?
Tentative approval from the FDA is given to a company if its generic drug meets all safety, efficacy, and quality standards for regulatory approval before the expiration of any patents or exclusivities tied to the generic drug’s RLD product.
- See here for more insight into this (and the expedited pathway options).
In the case of this RLD: The patents/exclusivities for LUMIFY are currently preventing Gland Pharma’s generic from being marketed in the United States.
Along those lines … wasn’t there another LUMIFY generic approved recently?
Indeed—Lupin Limited was also granted tentative approval for its own LUMIFY generic last July.
So what should we know about the name-brand drop?
LUMIFY was first introduced to the U.S. commercial market in 2017 as the first and only OTC drop of low-dose brimonidine tartrate to treat ocular redness due to minor eye irritations in adults and children aged 5+.
Since then, the LUMIFY brand has expanded to include:
- A line of specialty eye care products dubbed LUMIFY EYE ILLUMINATIONS
- Check out our coverage of the September 2023 launch
- A preservative-free (PF) version of the LUMIFY drop
- See here for details on its May 2025 launch
Can we get a look at its ingredients?
Aside from brimonidine tartrate (the active ingredient)? Absolutely.
See here for its active and inactive ingredient list.
And what are the dosing requirements?
Per LUMIFY’s clinical information—which Gland Pharma’s generic mirrors—one drop of the brimonidine tartrate formulation should be topically administered in the affected eye(s) every 6 to 8 hours.
- The intent: For the drop to provide up to 8 hours of relief.
But take note: Users are advised not to instill the drops more than four times daily (QID), and contact lens wearers must remove their lenses prior to installation—and only re-insert (at a minimum of) 10 minutes following drop use.
Noted. Speaking of real-world use … any data on the drops?
On LUMIFY? Yes! The original LUMIFY drop was actually compared to the PF version in a phase 3 clinical study.
No spoilers on the findings, though … you’ll have to check out our coverage of the research published in Ophthalmology and Therapy last July.
Now back to this generic—what’s next?
As with other generics’ tentative FDA approvals, its final approval will likely be delayed until all patent or exclusivity issues for the drug are resolved.
These issues may potentially include the federal agency:
- Requiring additional info from Gland Pharma
- Inspecting its manufacturing facilities
But to be clear: We don’t know any specifics on this at the moment.
As always, stay tuned for updates!