Clearside Biomedical, Inc. Q4 FY2023 earnings call

• In 2023, advanced CLS-AX clinical development for wet AMD, meeting targeted timelines and budget. Initiated and completed enrolment in the ODYSSEY Phase IIb trial on schedule. • Licensing partners made progress with four assets in clinical development for suprachoroidal delivery across five indications. • Announced a new collaboration with BioCryst Pharmaceuticals to use the SCS Microinjector for delivering orlistat to treat diabetic macular edema. • Highlighted real-world outcomes from XIPERE usage, which showed excellent durability with over 75% of eyes not requiring retreatment for six months after one dose. • The suprachoroidal injection procedure has a permanent Category 1 CPT code, and the SCS microinjector has a positive safety profile with over 2,000 injections performed to date. • Partners like REGENXBIO and Aura Biosciences made progress in their clinical trials utilizing suprachoroidal delivery.

No specific product segment financial performance data provided in the transcript.

• The primary data readout for the ODYSSEY Phase IIb trial in wet AMD is expected in the third quarter of 2024. • Continue to demonstrate the benefits of drug delivery into the suprachoroidal space using the SCS Microinjector device technology through ongoing trials and collaborations.

• Forward-looking statements made during the call are subject to risks outlined in the company's annual report on Form 10-K for the year ended December 31, 2023, and other SEC filings. No detailed discussion of specific operational risks was provided in the transcript.

Q: Asked about how Phase II trials for tyrosine kinase inhibitors (TKIs) are designed and harmonization of trials for wet AMD.

A: Discussed differences in trial designs, importance of enrollment criteria in the ODYSSEY trial, and the theoretical and clinical reasons why TKIs are a valuable addition to wet AMD treatment, noting their complementary nature with anti-VEGFA therapies.

Q: Inquired about the place of TKIs in maintenance treatment and ocular therapeutics' approach.

A: Talked about the maintenance therapy mindset, ocular therapeutics' trial in treatment-naive patients, and the expected clarity on the role of TKIs in wet AMD treatment as data from trials emerges.

Q: Questioned about enrollment criteria in the ODYSSEY trial and safety of suprachoroidal administration.

A: Explained that ODYSSEY enrolled patients with documented fluid, focusing on those with treatment experience, and noted the safety of suprachoroidal injection is comparable to intravitreal injections.

Q: Asked about potential patient dropouts in the ODYSSEY trial and XIPERE performance.

A: Addressed that early off-protocol rescues in prior trials were site-specific, expectations for minimal early rescues in ODYSSEY due to trial design, and stated XIPERE sales aren't reported yet as they haven't passed the $45 million royalty exclusion threshold.