InSite Vision Inc. (OTC MKTS:INSV) announced that it has completed the submission to the U.S. Food and Drug Administration (FDA) of the New Drug Application (NDA) of BromSite™ for the treatment of inflammation and prevention of pain in cataract surgery. 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 Visionshareholders, 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”. (Original Source)
Shares of Insite Vision closed yesterday at $0.1735 . INSV has a 1-year high of $0.36 and a 1-year low of $0.12. The stock’s 50-day moving average is $0.14 and its 200-day moving average is $0.18.
On the ratings front, Roth Capital analyst Scott Henry reiterated a Buy rating on INSV, with a price target of $0.70, in a report issued on May 19. The current price target implies an upside of 311.8% from current levels.
According to TipRanks.com, Henry has a total average return of 30.8%, a 69.7% success rate, and is ranked #29 out of 3621 analysts.
InSite Vision Incorporated is an ophthalmic product development company committed to advancing ophthalmic pharmaceutical products to address unmet eye care needs.