Research and Markets (http://www.researchandmarkets.com/research/bwg2xg/ista) has announced the addition of the "ISTA Pharmaceuticals' Remura - Will it bring tears to dry eyes?" report to their offering.
ISTA's REMURA is an ophthalmic bromfenac product that utilizes a new proprietary formulation designed to provide better ocular penetration at lower drug concentrations. Historically, ISTA has marketed a 0.09% formulation for use in the treatment of inflammation and pain following cataract surgery - initially as twice-daily Xibrom, and more recently as once-daily Bromday. ISTA hopes that the new forms, one of which is in development for the same post-surgical setting and the other which is in development for use in dry-eye syndrome, will help protect the franchise against generic erosion.
Relevant to that concern, the switch to a once-daily label with the Bromday rebranding provided 3 years of market exclusivity for that label, but FDA has just approved a generic for use with a twice-daily label. This report focuses on the dry eye program (REMURA), looking closely at the predictive value of existing phase II data. It also explores FDA's approval standards for agents that target use in this indication by reviewing several historical precedents. Finally, it looks at the overall market, competitive challenges, and pipeline products.
Key Topics Covered:
INTRODUCTION AND BACKGROUND
1. Dry-eye syndrome - Clinical presentation - Epidemiology - Disease Mechanisms - Current treatments
1. Preclinical and early phase data 2. Clinical data - Xibrom and Bromday used after cataract surgery - Phase II dry eye trials - Ongoing phase III trial
CLINICAL AND REGULATORY DISCUSSION
1. Are the phase II data adequate to predict phase III success? 2. Historical precedents. - Allergan's Restasis (ophthalmic cyclosporine) - Inspire's diquafosol - Vismed Tears - In summary 3. As always, safety concerns are key to approval - Will the history of bromfenac as an oral agent affect FDA's thinking? - What about topical safety? - Other potential concerns. 4. Patents and Citizen's Petitions
1. Market overview 2. Competitive profile 3. The pipeline
For more information visit http://www.researchandmarkets.com/research/bwg2xg/istaBusiness Wire
Last updated on: 11/10/2012
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