Opthea Limited announced the release of phase 2b clinical trial results of OPT-302 administered with ranibizumab (Lucentis, Genentech) for the treatment of wet age-related macular degeneration (AMD).
Tell me more about OPT-302.
OPT-302 is the first anti-vascular endothelial growth factor (VEGF) “trap” agent that is designed specifically for the eye. It binds and sequesters both VEGF-C and VEGF-D, which then prevents the activation of VEGF receptors 2 and 3.
By combining OPT-302 with ranibizumab, an anti-VEGF therapy, it could lead to potentially better anatomic and visual outcomes.
Anything else?
OPT-302 was granted Fast Track designation by the FDA in 2021 to treat wet AMD.
Talk about the trial.
The prospective, randomized, and controlled phase 2b trial (NCT03345082) included 366 treatment naíve patients with wet AMD and a best-corrected visual acuity (BCVA) between 25 and 60 Early Treatment Diabetic Retinopathy Study (ETDRS) letters, and was conducted at 109 clinical sites within the U.S., Israel, and Europe. Participants received six, four-weekly intravitreally-administered injections of either 0.5 mg OPT-302, 2 mg OPT-302, or sham, all with 0.5 mg ranibizumab.
What was the primary endpoint?
Primary efficacy endpoint was a statistically superior gain in visual acuity at 24 weeks compared to ranibizumab alone.
How about the results?
The study met its primary endpoint as well as recorded positive secondary outcomes for the OPT-302 combination therapy with participants having noted vision gains of 10+ letters or more, anatomical improvements with reduction in swelling and vascular leakage, and a favorable safety profile.
What’s next?
Opthea currently has two global confirmatory phase 3 studies underway to investigate the combination therapies of 2 mg OPT-302 + 0.5 mg ranibizumab (ShORe, NCT04757610) and 2 mg OPT-302 + 2 mg aflibercept (COAST, NCT04757636), respectively, for wet AMD treatment.