DexaSite NDA Submission Planned for 2015; AzaSite Plus™ Data and Endpoint Discussions with FDA Continue
European post-Phase 3/pre-MAA DexaSite and AzaSite Plus Blepharitis Discussions Scheduled for Q3 2014
ALAMEDA, Calif.--(BUSINESS WIRE)-- Following a June 16, 2014 meeting with the U.S. Food and Drug Administration (FDA), InSite Vision Incorporated (OTCBB:INSV) today announced that it intends to submit a New Drug Application (NDA) for DexaSite™ (dexamethasone 0.1% in DuraSite) as a treatment for blepharitis in adults during 2015, following completion of remaining chemistry and manufacturing work. In the June 16 meeting, the FDA agreed that in light of all of the historical clinical data for dexamethasone, the results of InSite's Phase 3 study of DexaSite could support marketing approval for DexaSite in the indication of blepharitis. In its landmark Phase 3 DOUBle study, DexaSite achieved superiority versus vehicle (p-value = 0.0053) at day 15 (following 14 days of twice-daily dosing) in the clinical symptom of irritation, which was singularly judged and reported by the patient. Another independent instrument employed in this study, the Health Related Quality of Life Questionnaire, which is a patient reported outcome instrument, also supported the irritation results outcome. InSite believes this is the first time a significant improvement in a blepharitis clinical symptom has been achieved in a Phase 3 setting.
InSite will meet with key European regulatory authorities in Q3 2014 to request this same DexaSite Marketing Authorization Application (MAA) filing path, as well as feedback on the need, if any, for additional AzaSite Plus (dexamethasone 0.1% and azithromycin 1% in DuraSite) data and/or endpoints to support an AzaSite Plus MAA filing in bacterial-related blepharitis. InSite will also continue to discuss AzaSite Plus data and endpoint requirements in bacterial-related blepharitis with the FDA, and InSite has committed to share with the FDA the results of all European blepharitis meetings, including all final meeting minutes, in an effort to harmonize the regulatory approach.
"We are pleased to have obtained FDA agreement that a single Phase 3 study can support a blepharitis NDA filing for DexaSite in 2015. If approved, DexaSite would be the first ophthalmology agent indicated for the treatment of blepharitis, which we believe is a significant commercial opportunity," said Timothy Ruane, InSite's Chief Executive Officer. "In addition to this key progress for DexaSite, we are continuing our efforts to submit an NDA during the second half of this year for BromSite for the prevention of inflammation and pain following ocular surgery."
"Blepharitis is estimated to affect 34 million patients in the U.S., and there is currently no approved therapy indicated to address this chronic inflammatory eye condition," said Kamran Hosseini, M.D., Ph.D., Vice President and Chief Medical Officer of InSite Vision. "Our strong working relationship with the FDA has been exemplified by this process; the FDA's feedback and input on the development of DexaSite for blepharitis has been extremely valuable as we collectively seek to develop a therapeutic with meaningful clinical benefit for this widespread ophthalmic condition. We look forward to similar positive blepharitis discussions with key European regulatory authorities in the third quarter of this year."
DexaSite is an investigational product that combines a low dose of the corticosteroid dexamethasone with InSite's proprietary DuraSite® drug delivery platform. InSite Vision has conducted two Phase 3 clinical trials of DexaSite. The first was completed in 2008 in blepharoconjunctivitis (inflammation of the eyelid and conjunctiva). More recently, InSite completed its landmark Phase 3 DOUBle (Dual Ophthalmic agents Used in Blepharitis) clinical trial of DexaSite and AzaSite Plus.
Blepharitis, also known as lid margin disease, is a common, chronic eye disease characterized by inflammation of the eyelid with periodic acute flare-ups. Symptoms of blepharitis may include redness, swelling, flaking skin, cysts, "gritty" or burning sensations, itching and vision impairment. The acute flare-ups of this disease can be painful and extremely irritating. It is estimated that greater than 34 million people in the U.S. suffer from blepharitis. There is currently no FDA-approved drug treatment for blepharitis.
About InSite Vision
InSite Vision is advancing new ophthalmologic products for unmet eye care needs based on its innovative DuraSite® 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® (azithromycin ophthalmic solution) 1%, marketed in the U.S. by Akorn Inc.; and Besivance® (besifloxacin ophthalmic suspension) 0.6%, marketed by Bausch + Lomb, a wholly owned subsidiary of Valeant Pharmaceuticals International. InSite Vision is also advancing two novel ophthalmic therapeutics through Phase 3 clinical studies: AzaSite Plus™ and DexaSite™ for the treatment of eye infections, and is preparing a new drug application (NDA) for the commercial approval by the U.S. Food & Drug Administration (FDA) of BromSite™ for the prevention of pain and inflammation associated with ocular surgery. For further information on InSite Vision, please visit www.insitevision.com.
Forward-looking Statements for InSite Vision
This news release contains certain statements of a forward looking nature relating to future events, including the filing of an NDA for DexaSite for the treatment of blepharitis and the expected timing thereof; the Company's commercial expectations for DexaSite; the Company's expected timing of filing an NDA for BromSite for the prevention of inflammation and pain following ocular surgery; the Company's plans and expectations for filing an MAA in Europe for DexaSite and AzaSite Plus; and the information set forth in the quotes from the Company's CEO and CMO. Such statements entail a number of risks and uncertainties, including but not limited to: the Company's ability to obtain substantial additional funding given that its current cash is currently projected to run out in September 2014; that the FDA could change its view of the Company's ability to file an NDA for either product based on current clinical data or for any other reason; that the expected timing for the filing of either NDA could be delayed for any number of reasons; that either NDA may not get approved and BromSite and DexaSite may not be approved for marketing or be commercially accepted; that the Company may not be allowed to file an MAA in Europe or may be asked to perform additional clinical studies in order to make such filing; the ability of the Company to enter into corporate collaborations for its product candidates; the Company's ability to expand its product platform; the Company's ability to compete effectively, either alone or through its partners, with other companies offering competing products or treatments; the Company'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 the Company'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 the Company, 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 unduly rely on such statements or information nor assume that the information provided in this release is still valid at any later date.
AzaSite® and DuraSite® 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.