Alembic Pharmaceuticals Limited announced the FDA approval of its abbreviated new drug application (ANDA) for loteprednol etabonate and tobramycin ophthalmic suspension, 0.5%/0.3% (5 mL and 10 mL)—a generic therapeutic of Bausch + Lomb’s ZYLET ophthalmic suspension.
First, a brief look at Alembic.
Based in Bedminster, New Jersey, the U.S. subsidiary of the multinational Indian pharmaceutical company currently sells 100+ products across the globe.
- Its targeted therapeutic and drug delivery areas extend to dermatology, injectables, oral and injectable oncology, and ophthalmology.
And in the generic area: Alembic previously launched brimonidine tartrate ophthalmic solution, 0.1%, a generic equivalent of AbbVie’s ALPHAGAN P ophthalmic solution for open-angle glaucoma (OAG) and ocular hypertension (OHT).
Now to this latest generic.
Loteprednol etabonate and tobramycin ophthalmic suspension, 0.5%/0.3% is a sterile, multiple-dose topical anti-inflammatory corticosteroid and antibiotic combination for ophthalmic use.
Its indication: For steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where superficial bacterial ocular infection or a risk of bacterial ocular infection exists.
And the dosing schedule: One or two drops topically administered into the conjunctival sac of the affected eye every 4 to 6 hours.
- Take note: The above information is based on the prescribing information (PI) from the name-brand version of this formulation.
Was there anything special about its ANDA approval?
Yes, actually … the FDA granted the generic formulation’s abbreviated new drug application (ANDA) a Competitive Generic Therapy (CGT) designation.
What this is: A regulatory designation reserved for products that have inadequate generic competition (no more than one other approved generic) in the commercial market due to low market potential, less profit margin, or complexity in manufacturing.
- What this does: Provides manufacturers (such as Alembic) with a new approval pathway to expedite the development and review of generic drugs lacking marketplace competition.
Are there any advantages to this post-approval?
Indeed. Thanks to its CGT designation, Alembic is now eligible for a 180-day exclusivity period for its generic formulation (once commercialized).
During this time period: No other generic drug with the same active ingredient, dosage form, or route can be approved by the FDA.
Talk about a major advantage. Now circle back to the formulation itself.
As we mentioned, loteprednol etabonate and tobramycin 0.5%.0.3% is a generic equivalent of B+L’s ZYLET ophthalmic suspension.
About ZYLET: The prescription-based eye drop received its initial FDA approval in 2004.
Are there any contraindications to be aware of?
But of course. As with other steroid anti-infective ophthalmic combination drugs, the PI notes that the formulation is contraindicated in:
- Most viral diseases of the cornea and conjunctiva
- Epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella
- Mycobacterial infection of the eye
- Fungal diseases of ocular structures
How about warnings or precautions?
A few callouts associated with prolonged corticosteroid use, including the potential for:
- Increased intraocular pressure (IOP; could lead to glaucoma with damage to the optic nerve or defects in visual acuity and fields of vision; IOP should be monitored if drops are used for 10+ days)
- Cataracts (may result in posterior subcapsular cataract formation)
- Delayed healing (as well as an increased risk for bleb formation post-cataract surgery)
- Bacterial, viral, and fungal infections
And if patients wear contact lenses, how should they use these drops?
They shouldn't.
The PI noted that, as with all ophthalmic formulations containing benzalkonium chloride, “patients should be advised not to wear soft contact lenses” when using the drops.
Got it. What about other potential adverse reactions?
There are a few to be aware of that were observed during clinical trials comparing ZYLET to a placebo.
Among the ocular adverse reactions: Superficial punctate keratitis (in 15% of patients); increased IOP (in 10%); and reports of burning or stinging upon instillation (in 9%).
Other reported ocular reactions (occurring in less than 4% of patients) included:
- Vision disorders, discharge, itching, lacrimation disorder, photophobia, corneal deposits, ocular discomfort, eyelid disorder, and “other unspecified eye disorders.”
As for non-ocular reactions: An estimated 14% of patients reported experiencing a headache.
Also noted. So … when and where will this be available for purchase?
No word yet on that front … check back with Alembic for details in the near future!