Expert Interview
Examining Uveitic Macular edema space ahead of the PDUFA date for XIPERE -October 19, 2019
Ticker(s): CLSDAn ophthalmologist with knowledge and experience about the space of Macular edema, Suprachoroidal CLS-TA and other competing treatments.
Please tell us about your clinical practice, background in treating Macular Edema associated with uveitis, and research in the space. How many patients do you treat,what is the first line of therapy? What % of patients do not respond well to first line?
How much of a need for new treatments is still there? Which get prescribed often and under what specific circumstances?
What advantages/disadvantages does suprachoroidal administration poses?
The FDA requested stability data for the triamcinolone acetonide (TA) suspension produced by Clearside. Do you see any risks coming from the manufacturing process that could pose troubles for approval?
Added By: slingshot_insightsWhat can you tell us about the SCS Microinjector platform, how well would it work as an in-office, non-surgical delivery into the suprachoroidal space?
In MAGNOLIA, 50% of XIPERE-treated patients maintained efficacy through 36 additional weeks after their second suprachoroidal injection of XIPERE, without requiring additional treatment. How does this compare to other treatments?
The mean time to rescue therapy in a 28 patients subset who were treated with XIPERE at baseline and week 12 of patients was over 9 months from their second injection in the PEACHTREE study. How does this dosing interval and stability compare to other choices you might have?
In the PEACHTREE study, 47% of patients in the XIPERE arm gained at least 15 letters in best corrected visual acuity. How well do those nrs. translate to an improvement in the patients’ outcomes?
Added By: slingshot_insightsHow likely would you be to switch your patients to XIPERE in the eventuality of an approval?
Added By: slingshot_insightsAre You Interested In These Questions?
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