FDA Approves Ophthalmic Gel for Postoperative Inflammation & Pain


The loteprednol etabonate ophthalmic gel 0.38% was proven efficacious and safe in a pair of double-masked trials, and will reach the market by April 2019.


The US Food and Drug Administration (FDA) has approved loteprednol etabonate ophthalmic gel 0.38% (LOTEMAX SM), a new gel formulation indicated for treating postoperative inflammation and pain in patients who have underwent ocular surgery.

The Bausch + Lomb ophthalmic gel was shown in clinical trials to provide a twice-greater penetration to the aqueous humor than loteprednol etabonate 0.5% (LOTEMAX GEL)—using a submicron particle size for faster drug dissolution in patients’ tears.

LOTEMAX SM is anticipated to reach the market by April 2019.

The FDA’s approval of the gel was based on the results of a pair of randomized, multi-center, double-masked, parallel-group trials involving 742 patients with postoperative inflammation. Included patients had received cataract surgery prior to treatment.

Investigators prescribed a three-time daily dose of the ophthalmic gel to the patient’s affected eye, beginning the day following surgery. Patients treated with LOTEMAX SM reported significantly improved resolution of ocular inflammation and pain versus vehicle. Twice as many treated patients achieved complete inflammation resolution by day 8 of treatment versus vehicle (30% vs 155; P < .0001).

A significantly greater rate of treated patients reported pain-free symptoms by day 8 versus vehicle (74% vs 50%; P < .0001). Investigators also reported a proven safety profile for LOTEMAX SM in the trials, with no treatment-emergent adverse drug reactions occurring in more than 1% of patients treated 3 times daily compared to vehicle.

According to Basuch + Lomb, the ophthalmic gel was designed with moisturizing ingredients including glycerin and propylene glycol, and has a pH close to that of human tears. Its preservative percentage (0.003% benzalkonium chloride) is the lowest ever in a loteprednol etabonate formulation.

Ocular inflammation is fairly prevalent in patients undergoing ocular surgery, and is often associated with pain and risk of serious complications, Marguerite McDonald, MD, an ophthalmologist and clinical professor at New York University School of Medicine, said in a statement. The addition of another Bausch + Lomb gel to the market gives physicians another means to providing quick care.

“LOTEMAX SM provides proven efficacy, efficient penetration, and less frequent dosing than LOTEMAX GEL, and the tolerability profile that we have come to expect from the loteprednol etabonate molecule,” McDonald said. “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.”

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