FOR RELEASE 2/20/2008, Wednesday
ROCHESTER, N.Y. — Peer-reviewed clinical results published in Current Medical Research and Opinion¹ show Zylet (loteprednol etabonate 0.5 % and tobramycin 0.3 % ophthalmic suspension) to be clinically equivalent to Tobradex (dexamethasone 0.1 % and tobramycin 0.3 % ophthalmic suspension) in decreasing the signs and symptoms of ocular inflammation in the treatment of blepharokeratoconjunctivitis. Additionally, subjects treated with Tobradex experienced a significant increase in intraocular pressure (IOP) compared to those treated with Zylet.
The 17-center, randomized, investigator-masked, parallel-group study enrolled a total of 276 patients, of which 263 patients completed the study. Subjects with clinically diagnosed blepharokeratoconjunctivitis in at least one eye were randomized to treatment with Zylet (n = 131) or Tobradex (n = 132) administered four times per day for 14 days. Clinic study visits were made on day 1 (Visit 1), day 3 +0/-1 day (Visit 2), day 7 +/- 1 day (Visit 3), and day 15 +/- 1 day (Visit 4).
The primary efficacy endpoint was the change from baseline to day 15 (+/- 1 day) in the signs and symptoms composite score using a non-inferiority metric to compare Zylet to Tobradex. At day 15, the mean (SD) change from baseline in the signs and symptoms composite score was
-15.2 (7.3) for Zylet treated subjects and -15.6 (7.7) for Tobradex treated subjects, representing a 78 percent reduction from baseline for both treatments. For all three study visits, the difference in change from baseline between treatment groups contained zero, indicating a lack of statistically significant difference between the treatments (90 percent confidence interval).
Safety endpoints included visual acuity (VA), biomicroscopy, IOP assessments, and adverse events. Subjects treated with Tobradex experienced a statistically significant increase in IOP when compared to those treated with Zylet at day 7 and at day 15.
These results are consistent with a peer review safety clinical authored by Dr. Edward Holland that was published in the January 2008 edition of Cornea². This 19-center, randomized, double-masked, parallel-group study compared the safety and tolerability of Zylet vs. Tobradex in healthy volunteers over a 28 day period. The results from this study indicate that Zylet was four times less likely to increase IOP when compared to Tobradex.
Zylet is indicated 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 where the inherent risk of steroid use in certain infective conjunctivitides is accepted to obtain a diminution in edema and inflammation.
As with other steroid-anti-infective ophthalmic combination drugs, Zylet is contraindicated in most viral diseases of the cornea and conjunctiva and also in mycobacterial infection of the eye and fungal diseases of ocular structures. Prolonged use of corticosteroids may result in glaucoma, as well as increase the hazard of secondary ocular infections. The incidence of adverse events reported by subjects treated with Zylet included injection (20 percent) and superficial punctate keratitis (approximately 15 percent). The development of secondary infection has occurred after use of combinations containing steroids and antimicrobials. NOT FOR INJECTON INTO THE EYE. Steroids should be used in caution in the presence of glaucoma. The use of steroids after cataract surgery may delay healing and increase the incidence of bleb formation. If this product is used for 10 days or longer, intraocular pressure should be monitored even though it may be difficult in children and uncooperative patients. Please visit www.bausch.com for full prescribing information.
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About Bausch & Lomb
Bausch & Lomb is the eye health company dedicated to perfecting vision and enhancing life for consumers around the world. Its core businesses include soft and rigid gas permeable contact lenses and lens care products, and ophthalmic surgical and pharmaceutical products. The Bausch & Lomb name is one of the best known and most respected healthcare brands in the world. Founded in 1853, the company is headquartered in Rochester, N.Y. With revenues in excess of $2 billion, it employs more than 13,000 people worldwide and its products are available in more than 100 countries. More information can be found at www.bausch.com.
Zylet is a registered trademark of Bausch & Lomb Incorporated. All other trademarks are the property of their respective owners.
References: 1.White EM, Macy JI, Bateman KM, Comstock, TL. Comparison of the safety and efficacy of loteprednol 0.5%/tobramycin 0.3% with dexamethasone 0.1%/tobramycin 0.3% in the treatment of blepharokeratoconjunctivitis .Curr Med Res Opin 2008;24(1)287-296. 2.Holland EJ, Bartlett,JD, Paterno M, Usner D, Comstock, TL. Effects of Loteprednol/Tobramycin Versus Dexamethasone/Tobramycin on Intraocular Pressure in Healthy Volunteers. Cornea 2208;27(1) 50-55.
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