rx perspective
Zylet: B&L's New Combination Drug
It's a challenger to TobraDex.
By Jerry Helzner, Senior Editor

With the recent approval of loteprednol etabonate 0.5% and tobramycin 0.3% ophthalmic suspension (Zylet), the collaboration between Bausch & Lomb and Pharmos Corporation must now be recognized as one of the most productive in the history of ophthalmic drug development. The partnership, which resulted in B&L buying Pharmos' loteprednol etabonate business in 2001, has led to the approval of three drugs in the loteprednol etabonate family, including the anti-inflammatory corticosteroids Alrex and Lotemax, and now the corticosteroid/antibiotic combination Zylet.

In this article, I'll discuss the indications for the use of Zylet and what specific advantages it may offer to ophthalmologists.

When to Use Zylet

Zylet is intended as a treatment 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. Bausch & Lomb says the efficacy and excellent safety profile of Zylet make it an appropriate choice for a variety of patients needing anti-inflammatory and anti-infective treatment, including steroid responders, ocular hypertensives, diabetics and individuals with glaucoma.

Zylet is likely to be used in treating ocular inflammations such as blepharitis, keratitis and conjunctivitis, where there is a concomitant infectious process, or the risk that an infectious process might occur. Zylet is also indicated when the need for a topical steroid might increase the risk of a secondary infectious process on a compromised ocular surface, such as with postoperative inflammation following both intraocular and extraocular surgeries.

Zylet is not indicated when an antibiotic with more specific anti-microbial activity can be targeted against a bacteria resistant to tobramycin.

Zylet is available in 2.5 mL, 5 mL and 10 mL bottle-fill sizes.

Challenges TobraDex

Zylet is the first new corticosteroid/antibiotic ophthalmic combination drug to be introduced in more than 15 years, and will primarily compete with tobramycin 0.3% and dexamethasone 0.1% (TobraDex), an Alcon product that started the year with about a 76% share of the market in the ophthalmic combination category. Zylet will also compete with other corticosteroid/antibiotic combinations and corticosteroid/sulfas.

In marketing Zylet, Bausch & Lomb hopes to build on the success of Lotemax, which has vaulted to market leadership in the branded topical steroid category.

"Since it was launched in 1998, I have used Lotemax as my steroid of choice for all types of internal and external ocular inflammatory conditions," says Charles Slonim, M.D., affiliate professor of ophthalmology at the University of South Florida College of Medicine in Tampa. "So my adoption of a related product, Zylet, was essentially a no-brainer."

Dr. Slonim notes that many ophthalmologists like to use an antibiotic whenever they use a steroid for an acute inflammatory condition.

"Zylet is a perfect drug for these conditions because the antibiotic (tobramycin) is time-tested, and the steroid (loteprednol etabonate) has excellent efficacy in these conditions, with a great safety profile demonstrating reduced adverse events, such as the increased IOP and cataract formation that are typically associated with topical steroids."

Dr. Slonim notes that TobraDex has existed for 15 years without a strong competitor. He says the excellent safety profile of loteprednol etabonate may encourage other doctors to switch to Zylet.

"A lot of doctors are feeling very comfortable using loteprednol etabonate," he notes.

Though Zylet has only been on the market for a few months, Bausch & Lomb says its sales are ramping nicely as more ophthalmologists become aware of its advantages.