Clearside Biomedical (CLSDQ) Status Update summary

Suprachoroidal platform and pipeline overview

• Proprietary SCS Microinjector validated in thousands of clinical injections and is the only FDA-approved product for suprachoroidal administration, commercialized as Xipere in the US and Asia-Pacific, with ongoing regulatory submissions in Canada, China, and Australia.

• Strategic collaborations established for gene therapy, oncology, and small molecule delivery, expanding the platform's reach and supported by a comprehensive IP portfolio.

• Manufacturing and reimbursement infrastructure in place, including ISO-certified facilities and a permanent CPT code for SCS injections.

• Internal pipeline includes CLS-AX for wet AMD, nearing completion of phase II-B, with data expected late Q3 2024, and partnered programs for choroidal melanoma, diabetic retinopathy, and diabetic macular edema.

• Patent protection for the SCS Microinjector extends to at least 2034, with potential for further extension.

Real-world and clinical data on suprachoroidal delivery

• Real-world IRIS Registry data for Xipere shows comparable durability to phase III PEACHTREE trial, with ~12% needing rescue steroids at 6 months and 87.7% of eyes not requiring additional corticosteroid by week 24.

• Suprachoroidal injections are used in patients with glaucoma, indicating physician comfort with the safety profile.

• Suprachoroidal delivery offers lower risk of endophthalmitis, fewer visual disturbances, and no implants in the vitreous compared to other routes.

• Expert consensus and published guidance support best practices for the procedure, emphasizing patient selection and technique.

• Suprachoroidal delivery offers targeted, in-office administration with potential for broader applications, including gene therapy and angiogenesis inhibitors.

CLS-AX wet AMD program and clinical strategy

• CLS-AX uses axitinib, a potent TKI, formulated for suprachoroidal delivery, aiming for longer duration and flexible redosing.

• Phase II-B ODYSSEY trial for CLS-AX in wet AMD is fully enrolled, with all patients completing six months and at least two doses; no drug-related serious adverse events reported and Safety Review Committee recommended the trial continue as planned.

• Primary endpoint at week 36; success defined by safety and comparable efficacy to aflibercept, with most patients reaching week 24 without retreatment.

• Phase III design will allow real-world flexibility, aiming for maintenance dosing every 12–24 weeks, addressing unmet needs in dosing intervals.

• Clinical trial designs with real-world retreatment criteria and active comparators are recommended to demonstrate true efficacy and safety.