Alembic Pharmaceuticals, Inc. has reportedly received FDA approval for difluprednate ophthalmic emulsion, 0.05%, a generic therapeutic with two indications.
Didn’t we just hear about an approval from this company?
We did—last month. In fact, the New Jersey-based global biopharmaceutical company (which specializes in generic development) was granted regulatory approval for two generics in 2025:
- June 2025: Prednisolone acetate ophthalmic suspension, 1% sterile
- Generic to Allergan, Inc’s (AbbVie’s) PredForte
- December 2025: Loteprednol etabonate and tobramycin 0.5%/0.3%
- Generic to Bausch + Lomb’s ZYLET
Now to this latest generic.
Difluprednate ophthalmic emulsion, 0.05% is indicated for the treatment of inflammation and pain associated with ocular surgery as well as for the treatment of endogenous anterior uveitis (EAU).
Its generic status: Was granted based on its formulation containing the exact same active ingredient as the brand-name drug as well as the same strength, quality, and effectiveness.
The main difference: Is the pricing, with its purpose being to serve as a lower-cost alternative with the same therapeutic effect as its name-brand counterpart.
- Check out the generic approval process, which requires an abbreviated new drug application (ANDA) approval from the FDA.
Let’s talk about difluprednate ophthalmic.
Generally speaking, difluprednate ophthalmic is a prescription-based corticosteroid formulated for the topical treatment of eye swelling and pain following ocular surgery.
And its name-brand counterpart?
That would be Sandoz’s DUREZOL, which was initially granted FDA approval in 2008.
So what are the dosing requirements?
Per DUREZOL’s prescribing information (PI)—which mirrors that of Amneal’s generic, the following dosing is recommended:
- For postop inflammation and pain: One drop instilled into the conjunctival sac of the affected eye four times daily (QID) beginning 24 hours after surgery and continuing throughout the first 2weeks of the postop period.
- For EAU: One drop instilled into the conjunctival sac of the affected eye QID after 14 days followed by tapering, as clinically indicated.
Is contact lens wear permitted with drop use?
The PI noted that lenses shouldn’t be worn when instilling the drops, as the formulation’s anti-microbial preservative could be "absorbed by soft contact lenses.”
- As such: Lenses should be removed prior to drop instillation and only reinserted 10 minutes after administration.
Any contraindications to be aware of?
A few … the drop is contraindicated in “most active viral diseases of the cornea and conjunctiva," according to its PI, including:
- Epithelial herpes simplex keratitis (dendritic keratitis)
- Vaccina
- Varicella
Others include: Mycobacterial infection of the eye and fungal diseases of ocular structures.
How about warnings or precautions?
Definitely a few:
- Increased intraocular pressure (IOP)
- Monitoring is advised if corticosteroid is used for 10+ days
- Cataracts
- Delayed healing
- Corneal and scleral melting
- Bacterial, viral, or fungal infections
Noted. Any other potential adverse reactions?
These would be based on clinical trial experience used to support the name-brand (DUREZOL) drop’s approval. We’ll break it down by individual indications:
For postop inflammation and pain: A few of the most common adverse reactions (developing in 5% to 15% of patients) include corneal edema, ciliary and conjunctival hyperemia, photophobia, posterior capsule opacification, eye pain, anterior chamber cells and flare, conjunctival edema, and blepharitis.
- Check out the PI’s Section 6.1 for more.
- And take note: The PI also emphasized that “most of these reactions may have been the consequence of the surgical procedure.
For EAU: Among the most common reactions (developing in 5% to 10% of patients) were blurred vision, eye irritation and pain, headache, increased IOP, iritis, as well as limbal and conjunctival hyperemia.
- Refer to the PI’s Section 6.2 for more.
Also duly noted. So … where will this be available for purchase?
No word yet on that front … check back with Amneal for details in the near future!