Bausch Health Companies Inc (BHC)

[Opti Mist]

Bausch + Lomb Announces The U.S. Launch Of LOTEMAX(R) SM (Loteprednol Etabonate Ophthalmic Gel) 0.38% For The Treatment Of Postoperative Inflammation And Pain Following Ocular Surgery
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7:00 AM ET 4/2/19 | Dow Jones


Shipments to U.S. Pharmaceutical Distributors Begin

BRIDGEWATER, N.J., April 2, 2019 /PRNewswire/ -- Bausch + Lomb, a leading global eye health company and wholly owned subsidiary of Bausch Health Companies Inc. (NYSE/TXS: BHC), today announced it has begun distributing LOTEMAX(R) SM (loteprednol etabonate ophthalmic gel) 0.38% to U.S. pharmaceutical distributors. The company received final approval by the U.S. Food and Drug Administration (FDA) on Feb. 22, 2019. LOTEMAX SM is a new gel drop formulation of loteprednol etabonate, which was designed with novel SubMicron (SM) technology for efficient penetration to key ocular tissues(1,2) at a low preservative (BAK) level(3,5-10) and a pH close to human tears.(4) It is indicated for the treatment of postoperative inflammation and pain following ocular surgery.(3)

"LOTEMAX SM is the culmination of our clinical experience with the loteprednol etabonate compound for more than two decades. We are extremely proud to make this new treatment option available, our most advanced loteprednol etabonate formulation to date, to help our customers address the needs of their patients undergoing ocular surgery who experience postoperative inflammation and pain," said Joe Gordon, U.S. president, Bausch + Lomb.

LOTEMAX SM delivers a submicron particle size and provides two times greater penetration to the aqueous humor as compared to LOTEMAX(R) GEL (loteprednol etabonate ophthalmic gel) 0.5%.(2) In addition, LOTEMAX SM was formulated with:

-- moisturizing ingredients1

-- a pH close to that of human tears4

-- the lowest BAK preservative percentage in a loteprednol etabonate

formulation (same percentage as LOTEMAX GEL [0.003 percent])3,5-10

"I am excited to now offer my postoperative patients who experience pain and inflammation LOTEMAX SM, with its proven efficacy, efficient penetration, and less frequent dosing compared to LOTEMAX GEL," said Marguerite McDonald, M.D., F.A.C.S., ophthalmologist and clinical professor of ophthalmology, New York University (NYU) School of Medicine. "In addition to the improved dosing compared to LOTEMAX GEL and the established efficacy, LOTEMAX SM offers a tolerability profile that I have come to rely on from the loteprednol etabonate molecule."

INDICATION

LOTEMAX(R) SM (loteprednol etabonate ophthalmic gel) 0.38% is a corticosteroid indicated for the treatment of post-operative inflammation and pain following ocular surgery.

DOSAGE AND ADMINISTRATION

Invert closed bottle and shake once to fill tip before instilling drops. Apply one drop of LOTEMAX(R) SM into the conjunctival sac of the affected eye three times daily beginning the day after surgery and continuing throughout the first two weeks of the post-operative period.