Global eye health firm Bausch + Lomb has secured approval from the US Food and Drug Administration (FDA) for its new gel formulation, Lotemax SM (loteprednol etabonate ophthalmic gel) 0.38%, to treat postoperative inflammation and pain following ocular surgery.
Lotemax SM takes the support of SubMicron (SM) technology to adhere to the ocular surface and then access crucial ocular tissues.
The new gel delivers a submicron particle size for quicker drug dissolution in tears, compared to Lotemax Gel (loteprednol etabonate ophthalmic gel) 0.5%.
Lotemax SM includes submicron particles, which will help optimize drug exposure into the aqueous humor.
Similar to Lotemax Gel, the new gel formulation is also provided with moisturizing ingredients (glycerin and propylene glycol), pH near to that of human tears and lowest preservative percentage in a loteprednol etabonate formulation
The approval was based on data from two randomized, multicenter, double-masked, parallel-group and vehicle-controlled studies in 742 patients with postoperative inflammation following cataract surgery.
Lotemax SM was administered three times daily to the affected eye starting the day after surgery and was demonstrated to be significantly more effective than vehicle in completely resolving ocular inflammation and pain following cataract surgery.
In the two studies, twice as many patients treated with Lotemax SM achieved complete inflammation resolution at day eight compared to vehicle, said the company.
Bausch + Lomb US president Joe Gordon said: “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.
“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.”
Bausch + Lomb, which is a wholly owned subsidiary of Bausch Health Companies, provides over-the-counter products, dietary supplements, eye care products, ophthalmic pharmaceuticals, contact lenses, lens care products, ophthalmic surgical devices and instruments.
The company markets its products to the customers in more than 100 countries across the globe.