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CCOI Workshop: Defining Global Standards for Glaucoma Endpoints

America/New_York
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Join us for this Event - Prior to the ASCRS Meeting

Registration is open! Please select one option for registration - in-person or virtual.  

Location: Walter E. Washington Convention Center


AgendaIntroductory RemarksSession 1: Current Global Regulatory Landscape for Glaucoma Medical Products Session 2: IOP as an Endpoint - Current LimitationsBreakSession 3: Accelerating the Viability of Functional Endpoints for Regulatory UseLunch: Open-Mic Q&A with Regulatory ExpertsSession 4: Structural EndpointsSession 5: Session 6: Industry Panel - Advancing Glaucoma CareBreakSession 7: Patient-Reported Outcomes in GlaucomaNext Steps & Closing Remarks

Agenda

Introductory Remarks

  • 8:00 AM – 8:10 AM - Welcome & Workshop Objectives
  • 8:10 AM – 8:15 AM - The Time Is Now: Advancing Glaucoma Innovation
  • 8:15 AM – 8:20 AM - CCOI: The Global Engine for Glaucoma Standards & Endpoints

Session 1: Current Global Regulatory Landscape for Glaucoma Medical Products 

  • 8:20 AM – 8:33 AM - US Regulation of Glaucoma Drugs
  • 8:33 AM – 8:46 AM - US Regulation of Glaucoma Devices
  • 8:46 AM – 8:59 AM - Global Regulation of Glaucoma Medical Products 
  • 8:59 AM – 9:12 AM - The Role of Standards in Medical Product Development
  • 9:12 AM – 9:25 AM - Clinical Perspective on Current Endpoints for Glaucoma Medical Products 

Session 2: IOP as an Endpoint - Current Limitations

  • 9:25 AM – 9:38 AM - Clinical Perspective on Current Glaucoma Endpoints
  • 9:38 AM – 9:51 AM - How can IOP Endpoints be Optimized?
  • 9:51 AM – 10:04 AM - Continuous IOP as an Endpoint: Is It Superior and How Should It Be Used?
  • 10:04 AM – 10:30 AM - Panel Discussion: The Future of IOP as an Endpoint

Break

Session 3: Accelerating the Viability of Functional Endpoints for Regulatory Use

  • 10:40 AM – 11:00 AM - Modern Analytics: Improving Endpoint Reliability
  • 11:00 AM – 11:20 AM - Functional Endpoint #1
  • 11:20 AM – 11:40 AM - Functional Endpoint #2
  • 11:40 AM – 12:15 AM - Panel Discussion: Making Functional Endpoints Regulatory-Ready

Lunch: Open-Mic Q&A with Regulatory Experts

Session 4: Structural Endpoints

  • 1:15 PM – 1:35 PM Structural Endpoints in Glaucoma: A Comprehensive Framework for Assessment and Innovation
  • 1:35 PM – 1:48 PM Regulatory Considerations for Devices Used in Structural Assessment of Glaucoma
  • 1:48 PM – 2:15 PM Panel Discussion: Closing the Gap Toward Regulatory Acceptance of Structural Endpoints 

Session 5: 

  • 2:15 PM – 2:35 PM - Functional Assessments in Glaucoma: Evaluating the Strength of the Current Evidence
  • 2:35 PM – 2:48 PM - Memantine in Glaucoma: Lessons Learned from a Landmark Neuroprotection Trial
  • 2:48 PM – 3:01 PM - Nicotinamide/Pyruvate: Metabolic Modulation as a Functional Strategy in Glaucoma
  • 3:01 PM – 3:14 PM - Enhancing blood flow : Advancing Functional Endpoints in Vascular-Targeted Glaucoma Therapy
  • 3:14 PM – 3:40 PM - Panel Discussion: Lessons Learned in Advancing Functional Endpoints in Clinical Trials

Session 6: Industry Panel - Advancing Glaucoma Care

  •  3:40 PM – 4:00 PM - The Urgent Need for Additional Glaucoma Endpoints to Enable the Next Generation of Therapies 
  • 4:00 PM – 4:45 PM - Panel Discussion: Industry Perspectives on the Need for Additional Glaucoma Endpoints to Drive Innovation

Break

Session 7: Patient-Reported Outcomes in Glaucoma

  • 4:55 PM – 5:08 PM - Available Patient-Reported Outcome Measures for Use in Glaucoma
  • 5:08 PM – 5:21 PM - FDA Use of PROS for Regulatory Decision
  • 5:21 PM – 5:34 PM - PROs as supportive endpoints linked to progression
  • 5:34 PM – 5:55 PM - Panel Discussion: Optimizing the Use of PROs in Glaucoma Clinical Trials 

Next Steps & Closing Remarks

If you have questions, or would like to Sponsor any activities at the Event, please contact us at info@cc-oi.org for sponsorship opportunities.

Other information: 

As this meeting is happening prior to ASCRS - please see hotel options associated with that event or around the Convention Center if you are not attending ASCRS or those options are not available.