Clearside Biomedical (CLSDQ) Study Result summary

Study design and patient population

• ODYSSEY was a 36-week, randomized, double-masked, multicenter Phase IIb trial in wet AMD, enrolling 60 participants with active disease previously treated with anti-VEGF therapy, confirmed by an independent reading center.

• Participants were randomized 2:1 to receive CLS-AX (1 mg) via suprachoroidal injection or aflibercept (2 mg) via intravitreal injection, with mandatory CLS-AX redosing at week 24 and flexible as-needed dosing between weeks 12 and 24.

• All participants had prior anti-VEGF treatment and persistent active disease, with a median disease duration of 9.9 months.

• Both arms received three aflibercept loading doses before randomization.

• High retention was achieved, with 97% completing through week 24 and 88% through week 36.

Efficacy and durability results

• The primary endpoint, mean change in BCVA at week 36, was met, with stable visual acuity and central subfield thickness maintained throughout the trial.

• CLS-AX reduced injection frequency by 84% compared to prior regimens, with 100% of participants going 3 months, 90% 4 months, 81% 5 months, and 67% 6 months without additional treatment.

• Stable anatomical control was observed, with minimal fluctuation in the CLS-AX group.

• BCVA remained within two letters of baseline at both week 24 and week 36 in the CLS-AX arm.

• CLS-AX reduced the average number of injections from 2.95 to 0.475 in the 24 weeks post-baseline.

Safety and tolerability

• CLS-AX demonstrated a positive safety profile, with no ocular or treatment-related serious adverse events, endophthalmitis, or retinal vasculitis reported.

• Four cases of mild intraocular inflammation were observed, all resolved by week 36; no vasculitis or posterior involvement occurred.

• Only one instance of mild injection pain was reported among 84 CLS-AX injections.

• Discontinuation rates were similar between CLS-AX and aflibercept groups, with most dropouts due to withdrawal of consent.

• CLS-AX was well-tolerated after repeat dosing, with no systemic drug/procedure-related SAEs.