Opthea Limited has appointed Arshad Khanani, MD, MA, FASRS, a globally recognized retina specialist and clinical scientist, as chief medical advisor.
Let’s talk company highlights first.
Founded in 2012 and headquartered in South Yarra, Australia, Opthea is a biopharmaceutical company focused on developing novel therapies for treating retinal diseases such as wet age-related macular degeneration (AMD) and diabetic macular edema (DME).
Its lead candidate, OPT-302 (sozinibercept), is the first anti-vascular endothelial growth factor (VEGF) “trap” agent designed specifically for the eye—but more on that later.
Gotcha. Now tell me about Dr. Khanani.
The managing partner, director of Clinical Research, and director of Fellowship at Sierra Eye Associates (SEA) in Reno, Nevada, Dr. Khanani is also credited with establishing the multispecialty ophthalmology practice's clinical research department.
Through this, SEA has become recognized as one of the top clinical research sites in the United States. The department is noted as currently having a “large number of clinical trials examining state-of-the-art treatments for common retinal diseases.”
Additionally, Dr. Khanani is a clinical associate professor at the University of Nevada, Reno School of Medicine.
What’s his clinical trial experience?
Dr. Khanani is also noted as having served as principal investigator of 120+ clinical trials—”consistently ranking as a top enroller in the nation across multiple phase 1-3 trials,” according to Opthea.
Most recently, he was chair of the phase 3 GATHER2 (NCT04435366) steering committee for Iveric Bio’s (an Astellas Pharma Inc. company) IZERVAY (avacincaptad pegol intravitreal solution) for the treatment of geographic atrophy (GA) secondary to AMD.
See here for the latest coverage of that trial (and click here for details on its FDA approval).
What else?
His other experience includes:
- Active participation as a member of national and international clinical trial steering committees and scientific advisory boards
- Serves as lead principal investigator for multiple national and global clinical trials
- Initiator of Clinical Trials at the Summit (CTS) meeting
- Member of the Macula Society and Retina Society
- 2019 honoree of the Nevada Business Magazine Healthcare Heroes Physician of the Year award
- 2021 honoree of the Senior Honor Award (American Society of Retina Specialists [ASRS])
- 2021 honoree of the ASRS Presidents’ Young Investigator Award
That’s pretty impressive … so what will his new role entail?
According to Opthea CEO Frederic Guerard, PharmD, Dr. Khanani’s experience as principal investigator for retinal disease-focused clinical trials will be utilized to support the continued clinical development and future registration + launch of sozinibercept.
“Sozinibercept has the potential to be the first new drug for wet AMD in more than 15 years to deliver superior visual gains when administered in combination with standard of care therapy,” he stated.
Tell me a little more about this candidate.
Granted Fast Track designation by the FDA in 2021 for wet AMD, sozinibercept is 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.
With strong phase 2b study data (see here for those details, reported in February 2023) combining OPT-302 with ranibizumab (Lucentis; Genentech), an anti-VEGF therapy, it could lead to potentially better anatomic and visual outcomes.
Most recently—as in just a few days ago—Opthea announced enrollment completion for its pivotal phase 3 COAST trial that will evaluate intravitreal injections of aflibercept combined with sozinibercept vs aflibercept vs standalone therapy (along with an update on a second phase 3 trial, ShORe).
Any input from Dr. Khanani on this?
Per the new CMO, the latest updates for Opthea’s sozinibercept program mark a pivotal moment for the company.
“With my extensive involvement in guiding numerous recently approved treatment modalities,” Dr. Khanani stated, “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.”