Opthea Limited announced updates to its executive leadership and senior management as the company prepares to report topline data on its wet age-related macular degeneration (AMD)-based clinical trials in the near future.
All position changes went into effect on Sept. 9.
Let’s dive into these new executive hires.
First up: Daniel Geffken, who’ll be taking over as Chief Financial Officer on an ad interim basis.
- Predecessor: Peter Lang
His previous position: Co-founder and Managing Director at Danforth Advisors
- Background: 30+ years in strategy, finance, and operations of life sciences companies
Next: Mike Campbell, who has been appointed Chief Commercial Officer.
- Predecessor: Judith Robertson
Previous position: Senior Vice President and Head of commercial at Viatris Eye Care
- Background: 30+ years of biotech and pharmaceutical commercial leadership experience, specializing in launching and commercializing retinal disease and ocular surface disease (OSD) treatments
- Genentech; Novartis; Shire (now Takeda Pharmaceuticals)
Now to these senior positions.
First: Dayong Li, PhD, appointed to Senior Vice President, Biometrics
Previous position: Senior Vice President, Biometrics, at Marinus Pharmaceuticals
- Background: Has held global roles in biometrics at pharmaceutical and biotech companies
- Forest Laboratories (now AbbVie); AstraZeneca
Next: Jen Watts, appointed to Vice President Global Clinical Operations
- Predecessor: Bruno Gagnon, BPharm, MSc
Previous position: Vice President, Clinical Operations at Complement Therapeutics
- Background: Served as Vice President of Clinical Operations at several clinical-stage biopharmaceutical companies; Clinical Sciences Director of Ophthalmology-Retina Lead (Novartis Institute of Biomedical Research); and oversaw early-to-late-stage clinical trials plus global clinical programs
- Oculis; Graybug Vision; Genentech; Actelion; Gilead Sciences
Lastly: Anthony Bonifazio, appointed to Vice President, Market Access
Previous position: Vice President, Access, Reimbursement, and Market Access at Astellas (formerly Iveric Bio)
- Background: 25+ years of commercial experience in market access, advocacy, reimbursement, and sales for retina, cardiovascular, and oncology
- Novartis; Genentech
Alrighty, now about these upcoming trials … what are they based on?
The phase 3 clinical program is evaluating Opthea’s wet AMD investigational candidate: sozinibercept (OPT-302).
What it is: The first anti-vascular endothelial growth factor (VEGF) “trap” agent designed specifically for the eye, working to bind and sequester both VEGF-C and VEGF-D—which then prevents the activation of VEGF receptors 2 and 3.
How it works: The therapeutic is administered via an intravitreal (IV) injection.
- What makes it unique: It’s currently the first and only drug that is well tolerated, has a strong safety profile, and has demonstrated strong clinical evidence of visual acuity (VA) superiority in combination with standard-of-care anti-VEGF-A therapy for wet AMD.
What has clinical data shown thus far?
Phase 2b clinical data (NCT03345082) reported in February 2023—based on sozinibercept in combination with ranibizumab injected every month versus ranibizumab + sham—found the following:
- Primary endpoint was met, with the sozinibercept combo therapy demonstrating superiority in VA
- See the complete findings.
And these phase 3 trials?
The multicenter, double-masked, sham-controlled, pivotal phase 3 trials include:
- COAST (Combination OPT-302 with Aflibercept Study [NCT04757636])
- Evaluating sozinibercept (2.0 mg) in combination with an anti-VEGF-A treatment (aflibercept 2.0 mg [Eylea; Regeneron])
- ShORe (Study of OPT-302 in combination with Ranibizumab [NCT04757610])
- Evaluating sozinerbercept (2.0 mg) with ranibizumab (0.5 mg)
And what’s being measured?
For both studies: The primary outcome measure is the mean change in Early Treatment Diabetic Retinopathy Study (ETDRS) best-corrected visual acuity (BCVA) letters.
- Time frame: From baseline to Week 52
Also within that time frame, secondary outcome measures include:
- Participants gaining 15+ ETDRS BCVA letters
- Participants gaining 10+ ETDRS BCVA letters
- Change in choroidal neovascularization (CNV) area, as measured by fluorescein angiography (FA)
And measured only at Week 52: Participants with the absence of both subretinal fluid and intraretinal cysts, as accessible via spectral-domain optical coherence tomography (SD-OCT).
So … when can we expect these data readouts?
2025.
Specifically, according to Opthea CEO Frederic Guerard, PharmD, topline data for the COAST study is expected in Q2 2025, while the ShORe study data is anticipated “in mid-calendar year.”