InSite Vision has started its first Phase III trial of BromSite (also known as ISV-303) to cut pain and inflammation after cataract surgery. BromSite delivers the non-steroidal anti-inflammatory drug (NSAID) bromfenac using InSite Vision's DuraSite drug delivery technology. Putting in eye drops or ointments can be a frustrating hit-and-miss process (and often more miss than hit). DuraSite is an eyedrop that turns into a gel, which keeps drugs on the surface of the eye for a few hours. This cuts the number of doses, and therefore could improve compliance and treatment outcomes.
In the trial, patients will be dosed twice a day with DuraSite alone or BromSite on the day before surgery, the day of surgery, and then for a fortnight after, to see what effect BromSite has on pain and inflammation.
BromSite has a large potential market, as cataract surgery is the most frequently performed ocular surgery in the United States with more than 3 million procedures annually, and levels are likely to increase as the population ages.
"BromSite has the potential to significantly improve care for patients undergoing cataract surgery in the rapidly growing eye surgery market," said Kamran Hosseini, vice president and chief medical officer at InSite Vision.
The company expects the first results from the study in late 2012 or early 2013, and is planning a second Phase III trial based on discussions with the FDA and regulators in Europe. Using BromSite could also prevent cystoid macular edema (CME), a rare side effect of eye surgery, and InSite Vision plans extra clinical trials for this indication if the product reaches the market.
- read the press release