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Re: DewDiligence post# 209717

Wednesday, 08/07/2019 9:50:53 AM

Wednesday, August 07, 2019 9:50:53 AM

Post# of 253165
OPT.AX +138% on phase-2 data in wet AMD showing statsig-better visual acuity for OPT-302/Lucentis vs Lucentis alone in high-dose-OPT-302 cohort:

https://www.globenewswire.com/news-release/2019/08/06/1898066/0/en/Opthea-Meets-Primary-Endpoint-in-Phase-2b-Study-of-OPT-302-in-Wet-AMD.html

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 mg OPT-302 combination therapy gained a mean of 14.2 letters [i.e. 2.8 lines] of vision from baseline on the Early Treatment of Diabetic Retinopathy Study (ETDRS) standardized eye chart at 24 weeks, compared to 10.8 letters [2.2 lines] in the control group, a statistically significant benefit of 3.4 letters (p=0.0107).

The 0.5 mg OPT-302 low dose group had a similar outcome to the control group (+9.4 letters).

OPT-302 is a VEGFR-3 “trap” molecule that blocks VEGF-C and VEGF-D.

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