Clearside Biomedical, Inc. (NASDAQ:CLSD) Suprachoroidal Space Drug Delivery Webinar
Summary
Company Overview and Focus
- Focus: Clearside Biomedical specializes in suprachoroidal drug delivery.
- Key Achievements:
- SCS Microinjector: Thousands of clinical injections validated.
- FDA Approval: First and only product approved for suprachoroidal administration.
- Strategic Collaborations: Multiple partnerships with external companies.
- Intellectual Property: Extensive portfolio covering design, manufacture, and use of the suprachoroidal microinjector platform.
- Phase IIb Trial: Axitinib for wet AMD nearing completion.
Manufacturing and Regulatory Experience
- Manufacturing: ISO-certified commercial-scale manufacturing capability.
- Regulatory Pathway: Extensive experience in drug-device combination regulatory pathway.
- CPT Code: Permanent CPT code for SCS injections aids physician reimbursement.
Pipeline and Collaboration Highlights
- CLS-AX: Phase IIb wet AMD product, nearing completion.
- XIPERE: First suprachoroidal administration product, currently commercialized in the U.S. by Bausch & Lomb, with ongoing Canadian approval efforts.
- ARCATUS: Being developed by Arctic Vision in the Asia-Pacific region.
- Collaborations:
- Aura: Using Clearside’s SCS Microinjector for treating choroidal melanoma.
- REGENXBIO and AbbVie: Phase II studies using RGX-314 for diabetic retinopathy and wet AMD.
- BioCryst: Developing a plasmakallikrein inhibitor for suprachoroidal administration.
Real-World Use of Suprachoroidal Delivery
- Suprachoroidal Space: Accessible via microneedles or microcatheterization.
- Visual Evidence: Studies show measurable expansion of the suprachoroidal space post-injection.
- Triamcinolone Acetonide: Tested across various retinal conditions, with significant functional efficacy shown in the Phase III PEACHTREE study.
- Real-World Performance: Bausch & Lomb’s IRIS Registry study indicates sustained efficacy and low rescue rates for XIPERE in real-world settings.
Key Data Points
- Patient Demographics: 41% of patients had pre-existing glaucoma or ocular hypertension.
- Efficacy: Patients treated with XIPERE showed improved vision and low rescue rates up to six months post-injection.
This summary highlights Clearside Biomedical's focus on suprachoroidal drug delivery, key achievements, pipeline developments, and real-world performance data.
