ALAMEDA, Calif.--()--InSite Vision Incorporated (OTCBB: INSV) today announced that patient enrollment has been completed in the first Phase 3 clinical trial of BromSite™ (ISV-303) for the reduction of pain and inflammation after cataract surgery. BromSite combines a low dose (0.075%) of the non-steroidal anti-inflammatory drug (NSAID) bromfenac with InSite Vision’s DuraSite® drug delivery technology.
“We are finalizing our plans for a second Phase 3 clinical study of BromSite and, pending positive results from both trials, are committed to filing a New Drug Application for BromSite in 2013.”
This study enrolled more than 240 patients undergoing cataract surgery in a two-arm trial designed to evaluate the efficacy and safety of BromSite against the DuraSite vehicle alone. At 15 separate sites, patients were 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. Currently, about 80 patients remain on-study. InSite Vision expects that the Phase 3 BromSite clinical trial will be complete and top-line data available in early 2013.
“We are very pleased with the rapid enrollment of the Phase 3 BromSite study. Begun in August, our team has surpassed expectations for accrual and we now look forward to announcing top-line data for the Phase 3 clinical trial of BromSite early next year,” said Timothy Ruane, Chief Executive Officer of InSite Vision. “We are finalizing our plans for a second Phase 3 clinical study of BromSite and, pending positive results from both trials, are committed to filing a New Drug Application for BromSite in 2013.”
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. InSite is finalizing the design of the second Phase 3 study for BromSite pending full input from the regulatory agencies.
“Cataract surgery is the most frequently performed ocular surgery in the U.S. and we believe there is significant opportunity to improve patient care following these procedures,” said Kamran Hosseini, M.D., Ph.D., Vice President and Chief Medical Officer of InSite Vision. “Prior clinical trials of BromSite demonstrated superiority over the then market-leader, with twice the tissue penetration using a lower dose of bromfenac due to its formulation in our proprietary DuraSite vehicle. Better tissue penetration should reduce inflammatory symptoms, which are key to preventing post-surgical side effects, in addition to providing longer lasting pain relief to patients.”
InSite reported results in March 2011, from a Phase 1/2 clinical study of 169 patients undergoing cataract surgery, in which 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. In a Phase 2 clinical study evaluating pharmacokinetics, BromSite achieved more than twice the eye tissue penetration than Bromday™ (bromfenac ophthalmic solution) 0.09% marketed by ISTA Pharmaceuticals. Results from the Phase 2 clinical trial comparing BromSite to Bromday were released in October 2011.
About Cataract Surgery
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. 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® 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® and Besivance®. 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 ophthalmic products for unmet eye care needs based on its innovative DuraSite® platform technologies. The DuraSite drug delivery system extends the duration of drug retention on the surface of the eye, thereby reducing frequency of treatment and improving the efficacy of topical drugs. DuraSite 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 is also advancing three novel ophthalmic therapeutics through Phase 3 clinical studies: AzaSite Plus™ and DexaSite™ for the treatment of eye infections, and BromSite™ for pain and swelling associated with ocular surgery. DuraSite 2® incorporates InSite’s proprietary bioadhesive core technology with a cationic polymer to achieve sustained and enhanced ocular delivery of drugs. The DuraSite 2 platform, once approved, will be applied to InSite’s future pipeline product candidates and available through a broad licensing program for advanced ophthalmic drug development. For further information on InSite Vision, please visit www.insitevision.com.
This news release contains certain statements of a forward looking nature relating to future events, including InSite's Phase 3 trial for BromSite, InSite’s plans for a second BromSite Phase 3 trial, the expected timing of finalizing and reporting the results of the first BromSite Phase 3 trial, the expected benefits of BromSite, future potential indications for BromSite, InSite’s plans with respect to filing an NDA for BromSite and the timing thereof, and InSite’s plans with respect to DuraSite 2. Such statements entail a number of risks and uncertainties, including but not limited to: the timing of completion of the Phase 3 trials, the results of the Phase 3 trials and the timing thereof, InSite’s ability to obtain FDA approval of BromSite and the timing thereof; InSite's reliance on third parties to conduct its clinical trials, including the BromSite trials and the effectiveness of same; InSite’s reliance on third parties for the commercialization of its products and the effectiveness of such third parties; the ability of InSite to enter into corporate collaborations for its product candidates, including BromSite; 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®, DuraSite® and DuraSite 2® are registered trademarks of InSite Vision Incorporated. AzaSite Plus™, BromSite™ and DexaSite™ are trademarks of InSite Vision Incorporated.
BESIVANCE® is a registered trademark of Bausch + Lomb Incorporated.