InSite Vision Completes Enrollment of Confirmatory Phase 3 Clinical Study of BromSite(TM) for the Reduction of Inflammation and Pain after Cataract Surgery
Study Results Expected by Year-End 2013
ALAMEDA, Calif., Oct 01, 2013 (BUSINESS WIRE) -- InSite Vision Incorporated INSV +9.52% today announced that the last patient has been enrolled in the confirmatory Phase 3 clinical trial of BromSite(TM) (ISV-303) for the reduction of inflammation and pain after cataract surgery. BromSite combines a low dose (0.075%) of the non-steroidal anti-inflammatory drug (NSAID) bromfenac with InSite Vision's DuraSite(R) drug delivery technology. Pharm-Olam International served as the contract research organization (CRO) managing the BromSite study on behalf of InSite Vision.
InSite Vision expects that top-line data from the BromSite confirmatory Phase 3 study will be available late in the fourth quarter of 2013. This study enrolled about 240 patients undergoing cataract surgery in a two-arm trial designed to evaluate the efficacy and safety of BromSite against the DuraSite vehicle alone. Patients were randomized and then dosed twice-a-day beginning the day before surgery and continuing the day of surgery and for 14 days post-surgery.
In March 2013, InSite Vision announced positive results from the first Phase 3 clinical study of BromSite that enrolled 268 patients. The primary endpoint of that study was the reduction of inflammation after surgery and BromSite achieved statistically significant superiority compared to vehicle (p<0.001). A secondary endpoint was reduction in pain and BromSite achieved statistically significant superiority compared to vehicle (p<0.001). The confirmatory Phase 3 clinical study in support of BromSite's regulatory submissions utilizes the same endpoints, and the same CRO, as the first study. The confirmatory study for BromSite was designed with full input from both the U.S. Food and Drug Administration and European regulatory authorities.
About Cataract Surgery
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. Anti-inflammatory eye drops are also administered as prophylaxis against cystoid macular edema, or CME. CME is a relatively rare, but extremely serious, adverse event in ocular surgery that can lead to blindness. Many physicians believe that a higher penetration of bromfenac into the ocular tissues may reduce the risk of CME. InSite intends to do additional clinical studies post-approval in pursuit of adding prevention of CME to the BromSite label.
About DuraSite(R) and DuraSite 2
While eye drops are a proven delivery mechanism for numerous ocular drugs, efficacy of these agents is impeded by tears and blinking, which rinse the drug from the surface of the eye and limit retention and absorption. InSite's DuraSite and DuraSite 2 platforms are sustained delivery technologies using a synthetic polymer-based formulation designed to extend the residence time of a drug relative to conventional topical therapies. DuraSite and DuraSite 2 enable topical delivery of a solution, gel or suspension and can be customized for delivering a wide variety of potential drug candidates. The DuraSite platform is currently leveraged in two commercial products for the treatment of bacterial eye infections, AzaSite(R) and Besivance(R). InSite Vision is advancing a portfolio of novel preclinical- to clinical-stage ophthalmic products based on the DuraSite platform and anticipates advancing future ophthalmic product candidates using the DuraSite 2 platform.
About InSite Vision
InSite Vision is advancing new ophthalmologic products for unmet eye care needs based on its innovative DuraSite(R) platform technologies. The DuraSite and DuraSite 2 drug delivery systems extend the duration of drug retention on the surface of the eye, thereby reducing the frequency of treatment and improving the efficacy of topical drugs.
The DuraSite platform is currently leveraged in two commercial products for the treatment of bacterial eye infections, AzaSite(R) (azithromycin ophthalmic solution) 1%, marketed in the U.S. by Merck, and Besivance(R) (besifloxacin ophthalmic suspension) 0.6%, marketed by Bausch + Lomb. InSite Vision is also advancing three novel ophthalmic therapeutics through Phase 3 clinical studies: AzaSite Plus(TM) and DexaSite(TM) for the treatment of eye infections, and BromSite(TM) for pain and inflammation associated with ocular surgery. For further information on InSite Vision, please visit www.insitevision.com, or connect with the Company on Facebook, Twitter, LinkedIn, Google+, and SlideShare.
This news release contains certain statements of a forward looking nature relating to future events, including the expected timing of reporting the results of the second, confirmatory BromSite Phase 3 trial, the expected benefits of BromSite, future potential indications for BromSite, and InSite's plans with respect to DuraSite 2. Such statements entail a number of risks and uncertainties, including but not limited to: the results of clinical trials for BromSite and the timing thereof, InSite's ability to obtain FDA approval of BromSite and the timing thereof; InSite's reliance on third parties for the commercialization of its products; the ability of InSite to enter into corporate collaborations for its product candidates; InSite's ability to expand its product platform, including BromSite, to include additional indications; InSite's ability to compete effectively, either alone or through its partners, with other companies offering competing products or treatments; InSite's ability to maintain and develop additional collaborations and commercial agreements with corporate partners, its ability to adequately protect its intellectual property and to be free to operate with regard to the intellectual property of others; and determinations by the FDA. Reference is made to the discussion of these and other risk factors detailed in InSite Vision's filings with the Securities and Exchange Commission, including its annual report on Form 10-K and its quarterly reports on Form 10-Q, under the caption "Risk Factors" and elsewhere in such reports. Any forward-looking statements or projections are based on the limited information currently available to InSite Vision, which is subject to change. Although any such forward-looking statements or projections and the factors influencing them will likely change, InSite Vision undertakes no obligation to update the information. Such information speaks only as of the date of its release. Actual events or results could differ materially and one should not assume that the information provided in this release is still valid at any later date.
AzaSite(R) and DuraSite(R) are registered trademarks of InSite Vision Incorporated. AzaSite Plus(TM), BromSite(TM) and DexaSite(TM) are trademarks of InSite Vision Incorporated. BESIVANCE(R) is a registered trademark of Bausch & Lomb Incorporated.
SOURCE: InSite Vision