Lupin Limited is introducing a new generic eye drop to the U.S. market: loteprednol etabonate ophthalmic suspension, 0.5%—bioeqiuvalent to Bausch + Lomb’s Lotemax.
Refresh me on Lupin.
The India-based multinational generic pharma company specializes in developing and commercializing an extensive portfolio of products and ingredients, including branded and generic formulations.
- Among its therapeutic areas of focus: Cardiology, dermatology, gynecology, ophthalmology, respiratory, urology (just to name a few).
In the United States: Lupin has a subsidiary located in Baltimore, Maryland.
- On the generic front: The company has reportedly received over 250 FDA approvals and is currently marketing 180 products
- See its product inventory—and for ophthalmic-specific generics, click here—plus check out what other generics it’s recently launched.
Now talk about this latest generic.
Loteprednol etabonate ophthalmic suspension, 0.5%, is formulated as a sterile, topical anti-inflammatory corticosteroid intended for ophthalmic use.
- Specifically: The suspension is indicated for the treatment of postoperative inflammation and pain following ocular surgery.
Quick recap: Loteprednol, its active ingredient, is typically used to treat eye pain, redness, and swelling caused by certain ocular problems or surgery (but more on this purpose in a moment).
Get specifics on these other indications.
The generic is indicated for treating steroid-responsive inflammatory conditions of the:
- Palpebral and bulbar conjunctiva
- Cornea and anterior segment of the globe (see here)
Per Lupin, the use for these conditions is subject to “when the inherent hazard of steroid use is accepted to obtain an advisable diminution in edema and inflammation.”
And its name brand counterpart is Lotemax?
That’s correct. This is based on the FDA standards for bioequivalence, which constitutes that the suspension’s mechanism of action and indication must be a direct match.
In other words: The generic version should be able to reach the part of the body where it is intended to work at the same time and in the same amount (concentration level) as the brand-name medication.
- Check out the approval process for this (which involves an abbreviated new drug application submission).
Also keep in mind: There are several generic versions of this prescription-only suspension already available on the U.S. market.
Noted. Now talk about the suspension’s dosing requirements.
Based on the prescribing information (PI) for its name-brand counterpart, one bottle of the suspension contains 5 mg/g of loteprednol etabonate, packaged as a sterile preserved ophthalmic gel.
Its recommended dosage: One to two drops should be administered into the conjunctival sac of the affected eye four times daily (QID).
- When: Drop administration should start the day after surgery and continue throughout the first two weeks of the postoperative period.
Any contraindications to be aware of?
A few. As an ophthalmic corticosteroid, the suspension is contraindicated in “most viral diseases of the cornea and conjunctiva.” These include:
- Epithelial herpes simplex keratitis (dendritic keratitis)
- Vaccina
- Varicella
- Mycobacterial infection of the eye
- Fungal diseases of ocular structure
Noted. Sticking with the theme: how about warnings or precautions?
Of course there are. Those causes for concern:
- Increased intraocular pressure (IOP)
- If the eye drop is used for 10+ days, a patient’s IOP should be monitored.
- Glaucoma, as prolonged corticosteroid use can cause optic nerve damage and defects in visual acuity and fields of vision
Other potential developments extend to: cataracts; delayed healing (and increased risk for bleb formation); and bacterial, fungal, and viral infections.
Also take note: Contact lenses should not be worn during a course of therapy with loteprednol etabonate.
Also duly noted. So … where will this be available for purchase?
Check back at Lupin’s product inventory tracker for more details.