2024-07-24 23:23:06 ET
Clearside Biomedical, Inc. (CLSD)
Suprachoroidal Space Drug Delivery Call
July 24, 2024 08:00 AM ET
Company Participants
Jenny Kobin - Investor Relations
George Lasezkay - President and Chief Executive Officer
Glenn Yiu - Scientific Advisory Board
Victor Chong - Chief Medical Officer
David Brown - Director of Research, Retina Consultants Houston
Conference Call Participants
Annabel Samimy - Stifel
Andreas Argyrides - Oppenheimer & Co.
Serge Belanger - Needham & Company
Yi Chen - H.C. Wainwright
Presentation
Operator
Greetings, and welcome to the Clearside Biomedical KOL Webinar. As a reminder, this event is being recorded.
I would now like to introduce your host, Jenny Kobin, Clearside Investor Relations. Please go ahead.
Jenny Kobin
Good morning, everyone, and thank you for joining us today. Before we begin, I would like to remind you that during today's events, we will be making certain forward-looking statements that represent our views as of today. Various remarks that we make about the company, its future expectations, plans and prospects constitute forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors including those discussed in our SEC filings available on our website.
Today's agenda is provided on Slide 3. Dr. George Lasezkay, Clearside's President and CEO, will highlight the versatility of suprachoroidal delivery. Dr. Glenn Yiu, Professor of Ophthalmology at the University of California, Davis, will cover the real-world use of suprachoroidal delivery. Dr. Victor Chong, Clearside's Chief Medical Officer, will discuss pipeline opportunities; and Dr. David Brown, Director of Research with Retina Consultants Houston, will provide the large practice view of suprachoroidal delivery. After the formal presentations, we will conduct a question-and-answer session that will also include Clearside's CFO, Charlie Deignan.
With that, I'm now pleased to turn the program over to George.
George Lasezkay
Thanks, Jenny. Next slide. At Clearside, our singular focus is delivering on the potential of suprachoroidal drug administration. We are the proven leader in the suprachoroidal space. Our proprietary SCS Microinjector has been used in thousands of clinical injections to date. Our injection platform has been validated in several ways. We've developed the first and only product to receive FDA approval for suprachoroidal administration. We've established multiple strategic collaborations with companies that have technologies or expertise that we don't possess internally.
And thirdly, we've created a comprehensive intellectual property portfolio around the design, manufacture and use of the suprachoroidal microinjector platform with many different drug categories in various retinal disease states. Finally, internally, we've developed a suprachoroidal delivered tyrosine kinase inhibitor, axitinib, for wet AMD that's just completing Phase IIb trial in the United States. The data from this trial is expected late third quarter of this year.
Next slide. At Clearside, we not only have an SCS Microinjector platform, but we have extensive formulation experience with small molecules for suprachoroidal delivery. We have an ISO certified commercial scale manufacturing capability for our microinjector. We have extensive experience in drug device combination regulatory pathway, as evidenced by our track record of obtaining the first and only SCS administered product, XIPERE, the approval from the FDA. And finally, we received a permanent CPT code for SCS injections to aid physician reimbursement for the use of suprachoroidal products....
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Clearside Biomedical, Inc. (CLSD) Suprachoroidal Space Drug Delivery (Transcript)