FORT LAUDERDALE, FLA. — Bausch + Lomb, the global eye health company, announced today that its new loteprednol etabonate (LE) gel formulation demonstrated safety and efficacy for the treatment of ocular inflammation after cataract surgery, according to clinical findings presented on May 10th at the 2012 Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting in Fort Lauderdale, Fla.
“The advanced loteprednol etabonate gel formulation offers significant benefits for the treatment of ocular inflammation,” said Richard D’Souza, Vice President of Development & Research, Bausch + Lomb. “The findings presented at ARVO suggest that the new gel formulation of loteprednol, a well-known anti-inflammatory medication, if approved, may offer physicians an exciting new option for treating post-operative ocular inflammation and pain following ocular surgery.”
According to two multi-center, randomized, double-masked clinical studies, significantly more patients treated with loteprednol etabonate gel had complete resolution of anterior chamber cells and no pain at day 8 and through the end of the study (day 18) compared with patients treated with vehicle.
Most drug-related ocular adverse events were mild in severity and resolved without treatment. Blurred vision was reported for one patient (out of 810) who was treated with vehicle and no patients treated with the loteprednol etabonate gel. In both studies, mean intraocular pressure was similar between treatment groups and consistently lower than baseline for both treatment groups at follow up visits. No serious adverse events were reported.
Bausch + Lomb developed the non-settling loteprednol etabonate gel formulation to provide enhanced viscosity for greater retention on the ocular surface and to eliminate the need for shaking before delivery to the eye. The loteprednol etabonate gel formulation includes glycerin and propylene glycol, two known moisturizers. It also has a pH level closer to that of human tears and contains a lower concentration of the preservative benzalkonium chloride (BAK) as compared to loteprednol etabonate suspension (0.003% vs. 0.01%).
In a pre-clinical study also presented at ARVO, rapid and sustained exposure to eye tissues was seen with the gel formulation. A second pre-clinical study demonstrated that drug particles do not settle within the gel formulation, thereby eliminating the need to shake the product before use.
Loteprednol etabonate is an ocular corticosteroid that was first approved by the FDA in 1998 for the treatment of inflammation following ocular surgery. The currently available LE suspension is also indicated for steroid-responsive inflammatory conditions of the eye such as allergic conjunctivitis, acne rosacea, iritis and selected infective conjunctivitides1. Loteprednol etabonate is also available as an anti-infective/corticosteroid combination2 as well as in an ointment formulation3 for ocular inflammation and pain post ocular surgery.
About Bausch + Lomb
Bausch + Lomb is one of the best-known and most respected healthcare companies in the world. Its core businesses include contact lenses and lens care products, ophthalmic surgical devices and instruments, and ophthalmic pharmaceuticals. Founded in 1853, the company is headquartered in Rochester, N.Y., and employs more than 11,000 people worldwide. Its products are available in more than 100 countries. More information is available at www.bausch.com.
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