OPT – Opthea Limited

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Melbourne, Australia; 7 August 2019 – Opthea Limited (ASX:OPT), a developer of novel biologic therapies for the treatment of eye diseases, today announced positive Phase 2b results demonstrating that OPT-302 combination therapy met the primary endpoint of superiority in mean visual acuity gain at 24 weeks compared to Lucentis® monotherapy in treatment-naïve patients with wet age-related macular degeneration (AMD).

The Phase 2b, randomized, double-masked, sham-controlled clinical trial recruited 366 wet AMD patients who were allocated to two intravitreal doses of OPT-302 (0.5 mg and 2.0 mg),administered monthly in combination with 0.5 mg Lucentis®over 24 weeks, versus a control group that received standard of care 0.5 mg Lucentis administered monthly.

Patients administered 2.0 mgOPT-302combination therapy gained a mean of 14.2 letters of vision from baseline on the Early Treatment of Diabetic Retinopathy Study (ETDRS) standardized eye chart at 24 weeks, compared to 10.8 letters in the control group, a statistically significant benefit of 3.4 letters (p=0.0107)(Figure 1 attached). The 0.5 mg OPT-302 low dose group had a similar outcome to the control group (+9.4 letters). Compared to Lucentis monotherapy, OPT-302(2.0 mg) combination treatment showed improvements across multiple secondary endpoints, including a higher proportion of patients with stable vision (defined as ≤ 15 letter loss from baseline),and those gaining ≥10and ≥15 letters of visual acuity.



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