With primary endpoints of a phase 3 trial of Loteprednol Etabonate being met in the fall of 2014, researchers are anxiously awaiting additional data to present in late 2015. The success of Loteprednol for treating both inflammation and pain in post-cataract surgical patients has led trial leaders to anticipate continued positive results to present to the Opthamolic Congress later this year. As an effectual, safe and tolerable opthamolic gel Loteprednol has proven in recent studies to be statistically superior when compared to a placebo gel. Bausch + Lomb/ Valeant Pharmaceuticals, the company that markets Loteprednol Etabonate as the brand name Lotemax, has perfected this anti-inflammatory eye drop, creating a gel with enhanced penetration to allow for swift relief. The first Phase 3 study gleaned encouraging results, which were highlighted by the action of this novel sub-micron particle size gel.
The initial Phase 3 study data included approximately 514 patients who were studied at 47 clinical sites around the United States. This randomized study was both a double-masked and parallel group study. Patients who were post cataract surgery were dosed with either Loteprednol Etabonate gel 0.38% or a vehicle gel. There were four groups of patients, receiving either the vehicle dose or the Loteprednol, two or three times a day. The main efficacy endpoint was a total resolution of anterior chamber cells, showing zero cells, indicating no ocular inflammation. This primary endpoint was evaluated at day eight of the study. Additionally, patients were evaluated for pain, with subjects expected to have rated their pain Grade 0 at the eight day mark after surgery. A statistically sizable difference was found in both the primary and secondary study results, with patients who received Loteprednol achieving complete resolution of eye pain by the eighth post-surgical day. An absence in eye inflammation was also noted in a statistically superior number of participants who were given Loteprednol as compared to a placebo, or the vehicle eye drop. Patients in the vehicle arm also displayed a great uptick in the use of rescue medication, even at days 15 and 18 post surgery. With pain and inflammation being serious issues for patients after cataract surgery, the advent of Loteprednol is reassuring for patients who wish to ensure optimal post-operative recovery. Loteprednol has proven and continues to show itself to be an efficacious steroid ophthalmologic gel for patients after cataract surgery. Minor side effects have been noted by patients, which have included complaints of dry, itchy or red eyes and a light burning sensation when the gel/drops are fist applied. No patients withdrew from the aforementioned trials due to adverse effects.
A startling 20 million American adults ages forty and older have cataracts, with 50 percent of adults in the U.S. over age 80 being diagnosed with this unfortunate condition. When untreated, cataracts can lead quickly to blindness. Medicare covers cataract surgery, and the United States government spends roughly 3.4 billion dollars annual on these procedures.
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