InSite VisionLouis Drapeau, 510-747-1220Chief Financial OfficerorBCC PartnersMedia and Investor inquiriesMichelle Corral, 415-794-8662Karen L. Bergman, 650-575-1509
InSite Vision Incorporated (OTCBB: INSV) today announced that patient enrollment has begun in the first Phase 3 clinical trial of BromSite (ISV-303) for the reduction of pain and inflammation after cataract surgery. This study will seek to enroll approximately 240 patients undergoing cataract surgery in a two-arm trial designed to evaluate the efficacy and safety of BromSite against the DuraSite vehicle alone. BromSite combines a low dose (0.075%) of the non-steroidal anti-inflammatory drug (NSAID) bromfenac with InSite Vision’s DuraSite drug delivery technology.
“BromSite has the potential to significantly improve care for patients undergoing cataract surgery in the rapidly growing eye surgery market,” said Kamran Hosseini, M.D., Ph.D., Vice President and Chief Medical Officer of InSite Vision. “We are confident this Phase 3 study will enroll quickly given the positive data obtained in our prior clinical trials of BromSite, including the statistically significant reduction in pain and inflammation achieved in our Phase 1/2 study with the same primary endpoint as this trial. We anticipate top-line results from this first Phase 3 study will be available in late 2012 or early 2013.”
The BromSite Phase 3 clinical study is a two-arm, double-blind, placebo-controlled clinical trial where the placebo arm will be the DuraSite vehicle. Using 15 separate sites, patients undergoing cataract surgery will be randomized and then dosed twice-a-day beginning the day before surgery and continuing the day of surgery and 14 days post-surgery. The primary study endpoint is the reduction of pain and inflammation after surgery. Pharm-Olam International has been selected to serve as the contract research organization managing the BromSite study on behalf of InSite Vision.
This is the first of two Phase 3 clinical studies in support of BromSite’s regulatory submissions. In the second quarter of 2012, InSite conducted an end-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) and two European regulatory meetings, where both BromSite pivotal trials were discussed. The design of the second Phase 3 study for BromSite will soon be finalized pending full input from both the European regulators and the FDA.
In the Phase 1/2 study of 169 patients undergoing cataract surgery, once-daily and twice-daily doses of BromSite were compared against the DuraSite vehicle alone. Once-a-day BromSite was demonstrated to be superior to vehicle (53.3% versus 19.0%, P-value of 0.0016) in reducing pain and inflammation. InSite reported results from the Phase 1/2 clinical study in March 2011. In a Phase 2 clinical study evaluating pharmacokinetics, BromSite achieved more than twice the eye tissue penetration than Bromday (bronfenac ophthalmic solution) 0.09% marketed by ISTA Pharmaceuticals. Results from the Phase 2 clinical trial comparing BromSite to Bromday were released in October 2011.
Cataract surgery is the most frequently performed ocular surgery in the United States with more than three million procedures annually. Both before and after surgery, anti-inflammatory eye drops are prescribed to reduce pain and inflammation. 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. Most 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.
InSite's DuraSite sustained delivery technology is a synthetic polymer-based formulation designed to extend the residence time of a drug relative to conventional topical therapies. It enables 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 and Besivance. InSite Vision is advancing a portfolio of novel preclinical- to clinical-stage ophthalmic products based on the DuraSite platform.
InSite Vision is advancing new ophthalmologic products for unmet eye care needs. The company’s product portfolio utilizes InSite Vision’s proven DuraSite bioadhesive polymer core technology, an innovative platform that extends the duration of drug retention on the surface of the eye, thereby reducing frequency of treatment and improving the efficacy of topically delivered drugs. The DuraSite platform is currently leveraged in two commercial products for the treatment of bacterial eye infections, AzaSite (azithromycin ophthalmic solution) 1%, marketed in the U.S. by Merck, and Besivance (besifloxacin ophthalmic suspension) 0.6%, marketed by Bausch + Lomb. InSite Vision’s clinical-stage ophthalmic product pipeline includes AzaSite Plus and DexaSite for the treatment of eye infections, BromSite for pain and inflammation associated with ocular surgery, and ISV-101 for the treatment of dry eye disease. For further information on InSite Vision, please visit .
This news release contains certain statements of a forward looking nature relating to future events, including InSite's planned Phase 3 trial for BromSite, the design, timing and potential outcome of same, and the expected benefits of the BromSite product. Such statements entail a number of risks and uncertainties, including but not limited to: the timing of full enrollment of the Phase 3 trials, 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 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 and DuraSiteare registered trademarks of InSite Vision Incorporated.BESIVANCE is a registered trademark of Bausch & Lomb Incorporated.