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Home > Industry News > Bausch + Lomb Announces Publication Of Pivotal Phase 3 Data On Loteprednol Etabonate Ophthalmic Gel, 0.38% In Journal Of Cataract And Refractive Surgery

Bausch + Lomb Announces Publication Of Pivotal Phase 3 Data On Loteprednol Etabonate Ophthalmic Gel, 0.38% In Journal Of Cataract And Refractive Surgery

Bausch + Lomb Announces Publication Of Pivotal Phase 3 Data On Loteprednol Etabonate Ophthalmic Gel, 0.38% In Journal Of Cataract And Refractive Surgery2018.09.06

 

LAVAL, QuebecSept. 5, 2018 -- Bausch + Lomb, a leading global eye health company and wholly owned subsidiary of Bausch Health Companies Inc. (NYSE/TSX: BHC), today announced that the Journal of Cataract and Refractive Surgery (JCRS) has published results of a pivotal Phase 3, multicenter, double-masked, vehicle-controlled, randomized, parallel-group study that evaluated the clinical safety and efficacy of submicron loteprednol etabonate ophthalmic gel, 0.38%.

In the study, this investigational formulation of loteprednol etabonate met both of the primary efficacy endpoints in that it was significantly more effective than vehicle in completely resolving ocular inflammation and pain following cataract surgery. Additionally, the results showed that submicron loteprednol etabonate ophthalmic gel, 0.38% had an acceptable safety profile regardless of whether it was administered two or three times per day.

Submicron loteprednol etabonate ophthalmic gel, 0.38% has a reduced concentration and reduced dosing frequency versus existing formulations of loteprednol etabonate.

"Patients who undergo cataract surgery commonly experience inflammation that can result in pain, compromised vision, increased intraocular pressure, and other complications when untreated," said Raymond Fong, M.D., founder of Raymond Fong Eye Care in New York, and lead author of the publication. "Although topical corticosteroids are widely used to reduce postoperative inflammation and pain, they are associated with potential side effects. These results are very encouraging as they show the efficacy of the submicron loteprednol etabonate ophthalmic gel, 0.38% in eliminating ocular inflammation and pain after cataract surgery with a safety profile similar to other loteprednol etabonate formulations."

The published Phase 3 study, which enrolled 514 patients, showed that a significantly greater proportion of patients who received submicron loteprednol etabonate ophthalmic gel, 0.38% dosed twice daily or three times daily had complete resolution of anterior chamber cells on postoperative day 8 (26.9 percent and 28.7 percent, respectively) compared with the vehicle group (9.3 percent; p<0.0001). Similarly, a significantly greater proportion of patients who received submicron loteprednol etabonate ophthalmic gel, 0.38% twice daily or three times daily had no ocular pain (grade 0) on day 8 (73.7 percent and 73.1 percent, respectively) compared with the vehicle group (47.7 percent; p<0.001). For patients in the submicron loteprednol etabonate ophthalmic gel, 0.38% group, statistically significant differences in both anterior chamber cells and ocular pain were sustained at all subsequent visits (through postoperative day 18) relative to vehicle. Additionally, significantly fewer patients in the submicron loteprednol etabonate ophthalmic gel, 0.38% twice daily group and three times daily group (14.0 percent and 11.1 percent, respectively) required rescue medication by day 8 compared with those in the vehicle group (41.9 percent; p<0.0001). The most common ocular adverse events were eye pain, photophobia (extreme sensitivity to light), and foreign body sensation.

"Bausch + Lomb is committed to innovation and addressing unmet needs in eye care. This submicron loteprednol etabonate ophthalmic gel, 0.38% is an example of continued advancements in our portfolio," said Tracy Valorie, general manager and senior vice president, U.S. Pharmaceuticals and Surgical, Bausch + Lomb. "The results highlighted in this publication support this promising investigational ophthalmic gel as a potential new treatment for postoperative inflammation and pain following ocular surgery, and we look forward to bringing it to market as quickly as possible."

The U.S. Food and Drug Administration has accepted the New Drug Application for submicron loteprednol etabonate ophthalmic gel, 0.38% with a Prescription Drug User Fee Act (PDUFA) action date of Feb. 25, 2019.

 

SOURCE Bausch Health Companies Inc.

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