Bausch + Lomb Announces FDA Approval of LOTEMAX SM 0.38%

Bausch + Lomb announced the U.S. Food and Drug Administration (FDA) has approved LOTEMAX SM (loteprednol etabonate ophthalmic gel) 0.38%, a new gel formulation for the treatment of postoperative inflammation and pain following ocular surgery. Compared to LOTEMAX GEL (loteprednol etabonate ophthalmic gel) 0.5%, LOTEMAX SM delivers a submicron particle size for faster drug dissolution in tears. LOTEMAX SM also provides two times greater penetration to the aqueous humor compared to LOTEMAX GEL.

"With the FDA approval of LOTEMAX SM, physicians can now prescribe to their patients our most advanced loteprednol etabonate formulation to date, indicated for the treatment of postoperative inflammation and pain following ocular surgery," said Joe Gordon, U.S. president, Bausch + Lomb. "Since Bausch + Lomb introduced the first formulation of loteprednol etabonate more than 20 years ago, we have continued to advance formulations that meet the changing needs of our patients. We are planning to make LOTEMAX SM available as a new treatment option for patients by April 2019."

Based on Bausch + Lomb's history and experience in loteprednol etabonate innovation over the last two decades, the Company developed LOTEMAX SM, which uses SubMicron (SM) Technology to adhere to the ocular surface and then penetrate key ocular tissues. The submicron particles in LOTEMAX SM help improve drug exposure into the aqueous humor. Similar to LOTEMAX GEL, LOTEMAX SM was formulated with moisturizing ingredients (glycerin and propylene glycol), a pH close to that of human tears and the lowest preservative percentage in a loteprednol etabonate formulation.

"Patients undergoing ocular surgery, including cataract surgery, often experience inflammation that needs to be treated. This inflammation can be painful and result in serious complications," said Marguerite McDonald, M.D., F.A.C.S., ophthalmologist and clinical professor of ophthalmology, New York University (NYU) School of Medicine. "In two clinical trials, LOTEMAX SM was significantly more effective than vehicle in completely resolving ocular inflammation and pain following cataract surgery, one of the most common operations performed in the United States. LOTEMAX SM provides proven efficacy, efficient penetration, and less frequent dosing compared to LOTEMAX GEL, and the tolerability profile that we have come to expect from the loteprednol etabonate molecule. Together these factors support LOTEMAX SM as an important new option for many of my patients who require treatment for inflammation and pain following ocular surgery."

The FDA approval of LOTEMAX SM was based on data from two randomized, multicenter, double-masked, parallel-group, vehicle-controlled studies in 742 patients with postoperative inflammation following cataract surgery. LOTEMAX SM was administered three times daily to the affected eye beginning the day after surgery and was shown to be significantly more effective than vehicle in completely resolving ocular inflammation and pain following cataract surgery. In these two studies, twice as many patients treated with LOTEMAX SM achieved complete inflammation resolution at day eight compared to vehicle (30 percent vs. 15 percent, p<0.0001). Additionally, significantly more patients treated with LOTEMAX SM were pain-free compared to vehicle at day eight (74 percent vs. 49 percent, p<0.0001) and day three (secondary endpoint; 72 percent vs. 50 percent, p<0.0001).

In the studies, LOTEMAX SM had a proven safety profile. There were no treatment-emergent adverse drug reactions that occurred in more than one percent of the subjects in the three times daily group compared to vehicle.

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