Clearside Biomedical (CLSDQ) Status Update summary

Strategic platform and pipeline overview

• Focused on suprachoroidal drug delivery, validated by FDA approval and extensive clinical use, including thousands of injections.

• Proprietary SCS Microinjector enables targeted, in-office drug delivery, used in multiple strategic collaborations and supported by ISO-certified manufacturing and a permanent CPT code.

• Internal pipeline includes CLS-AX for wet AMD (phase II-B, data expected late Q3 2024), Xipere for uveitic macular edema, and partnered programs for choroidal melanoma, diabetic retinopathy, and diabetic macular edema.

• Collaborations with Aura, REGENXBIO/AbbVie, BioCryst, and others expand platform applications to oncology, gene therapy, and other indications.

• Manufacturing and regulatory infrastructure supports commercial-scale production and physician reimbursement.

Real-world and clinical data insights

• Real-world use of Xipere in uveitic macular edema shows comparable durability to pivotal PEACHTREE trial, with ~12% needing additional corticosteroid within 24 weeks.

• 87.7% of eyes did not require injected or implanted corticosteroid by week 24 in real-world data, similar to 86.5% in the PEACHTREE trial.

• Physicians are comfortable using suprachoroidal steroids in patients with glaucoma, reflecting favorable safety perceptions.

• Suprachoroidal delivery is seen as a platform for multiple drug classes, including gene therapies and angiogenesis inhibitors.

Clinical practice and procedural considerations

• Suprachoroidal injections require specific technique but are easily adopted and similar in duration to intravitreal injections, adding only 30 seconds in high-volume practices.

• SCS Microinjector uses a 30G needle, causing less tissue damage compared to larger gauge needles.

• Patient selection and procedural nuances (needle length, injection site) are important for optimal outcomes.

• Expert consensus emphasizes perpendicular needle placement and slow injection to minimize discomfort.