InSite is seeking marketing approval of BromSite in the United States. In its confirmatory Phase 3 clinical trials, BromSite achieved statistically significant superiority to vehicle in alleviating ocular inflammation and the prevention of pain.
In such trials, BromSite was well tolerated with no significant safety concerns or drug-related serious adverse events reported. Cataract surgery is the most frequently performed ocular surgery in the United States with more than three million procedures annually.
Typically, anti-inflammatory eye drops are prescribed to reduce pain and inflammation both before and after surgery.
The filing of the BromSite NDA satisfies InSite’s obligation under its recently announced merger agreement with QLT Inc.
The merger transaction, which has been unanimously approved by the Boards of both companies, is subject to the approval of InSite Vision shareholders, a condition that the FDA has not refused to accept the BromSite NDA for review within 60 days after InSite Vision’s filing of the NDA, a condition that the FDA has not indicated that it will require InSite Vision to conduct additional clinical studies prior to approval of BromSite within 74 days after InSite Vision’s filing of the NDA, and other customary closing conditions.
QLT will not require a shareholder vote to conclude the transaction; InSite Vision will file a proxy statement with full disclosure of the transaction and will schedule a shareholder vote to approve the transaction.
QLT will provide InSite Vision with a line of credit until the transaction closes. The transaction is expected to close in the third quarter of 2015 and to be taxable to InSite Vision shareholders. Shares of the new company will trade on NASDAQ under the ticker "QLTI" and on the TSX under the ticker "QLT".