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As part of its preparation to progress Sozinibercept (OPT-302) – a new drug for neovascular age-related macular degeneration (nAMD) – towards registration and launch, Opthea has appointed internationally recognised retina specialist and clinical scientist, Arshad M. Khanani MD MA FASRS, as its Chief Medical Advisor.
Dr Khanani is also Managing Partner, Director of Clinical Research, and Director of Fellowship at Sierra Eye Associates, and Clinical Associate Professor at the University of Nevada, Reno School of Medicine. He has assumed the role of principal investigator for more than 120 clinical trials, and recently chaired the Phase 3 GATHER2 steering committee for Izervay, playing a pivotal role in Izervay’s approval for geographic atrophy.
“We are delighted to have Dr Khanani join Opthea as Chief Medical Advisor,” said Frederic Guerard, Chief Executive Officer for Opthea, a clinical-stage biopharmaceutical company. “Sozinibercept has the potential to be the first new drug for wet age-related macular degeneration in more than 15 years to deliver superior visual gains when administered in combination with standard of care therapy. Dr Khanani’s expert advice will help us progress this important medicine towards registration and launch.”
SOZINIBERCEPT AT A PIVOTAL MOMENT
Dr K hanani said Opthea and the sozinibercept program is at a “pivotal moment” having recently completed enrolments for COAST (Combination OPT-302 with Aflibercept Study), and with enrolments soon to be completed for the ShORe study (Study of OPT-302 in combination with R anibizumab) in 2024. Additionally, topline data disclosure from both pivotal trials is anticipated by mid-2025.
“ With my extensive involvement in guiding numerous recently approved treatment modalities, I am steadfast in my commitment to supporting Opthea in promptly concluding the pivotal trials and ushering sozinibercept towards enhancing vision outcomes for patients worldwide.”
If successful, the investigation of sozinibercept in combination with each of these two approved standard of care VEGF-A inhibitors could enable sozinibercept to be administered with either agent, Eylea (aflibercept) or Lucentis (ranibizumab).
ABOUT SOZINIBERCEPT
Sozinibercept is a soluble form of vascular endothelial growth factor receptor 3 ( VEGFR-3) expressed as an immunoglobulin G1 (IgG1) Fc-fusion protein. It binds and neutralises the activity of VEGF-C and VEGF-D on their endogenous receptors, VEGFR-2 and VEGFR-3. Research indicates that targeted inhibition of VEGF-C and VEGF-D can prevent blood vessel growth and vascular leakage which contribute to the pathophysiology of retinal diseases including nAMD. Sozinibercept has received Fast Track Designation from the US Food and Drug Administration for the treatment of nAMD.
Positive results from the Phase 2b study of sozinibercept, administered in combination with Lucentis (for the treatment of nAMD, published in Ophthalmology), met the pre-specified primary efficacy endpoint of a statistically superior gain in visual acuity at 24 weeks, compared to ranibizumab alone. In addition, secondary outcomes were positive for the combination therapy with sozinibercept, including more participants with gains in vision of 10 or more letters, improved anatomy with reduction in swelling and vascular leakage, with a favourable safety profile.