In the span of less than a year, Opthea Limited has named new U.S.-based leadership, appointed a chief medical advisor, and—most recently—welcomed nine international retinal experts to its newly-formed Medical Advisory Board (MAB).
That’s quite a number of developments … but let’s start with a company refresh.
Launched in 2012 and headquartered in South Yarra, Australia, Opthea is a biopharmaceutical company developing novel therapies for the following retinal diseases:
- Wet age-related macular degeneration (AMD)
- 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.
Now give me the rundown on these previous position updates.
We’ll take you back to October 2023, when the company made executive changes to support its strategy for increasing the U.S./global presence and commercialization of its lead asset.
The result:
- U.S.-based executive Fred Guerard, PharmD, took over as CEO, replacing Megan Baldwin, PhD, who transitioned to founder, chief innovation officer, and executive director
- Former Aerie Pharmaceuticals Inc.’s Chief Financial Officer (CFO) Peter Lang was also named Opthea’s CFO
Then, fast-forwarding to February 2024, Opthea named Arshad M. Khanani, MD, MA, FASRS, as its chief medical advisor.
Read about his extensive background as a globally-known retina specialist.
Moving on to this latest news.
The company announced the formation of a MAB (headed up by none other than the newly-named Chair Dr. Khanani) with nine retinal experts from across the globe, including:
- United States
- Argentina
- Australia
- China
- France
- Germany
- Israel
So … who are these experts?
The MAB members include:
- David S. Boyer, MD
- Andrew Chang, AM, MBBS (Hons), PhD FRANZCO, FRACS
- Frank G. Holz, MD, FEBO, FARVO
- Anat Lowenstein, MD, MHA
- Dante Pieramici, MD
- Carl Regillo, MD
- Patricio G. Schlottmann, MD
- Tien Y Wong, MD, PhD
- Eric Souied, MD, PhD
Read up on each expert’s credentials.
So why form an MAB?
Per Opthea, the company is at a “crucial stage” ahead of its plans for a phase 3 topline data read-out from two pivotal trials on its lead asset, OPT-302 (sozinibercept).
Let’s talk about that for a moment.
OPT-302 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.
Its regulatory status: The asset was granted Fast Track designation by the FDA in 2021 for wet AMD.
And its clinical data?
OPT-302 (2.0 mg) has demonstrated strong phase 2b study data when used in combination with ranibizumab (Lucentis; Genentech) for wet AMD.
- The potential of this duo: achieving better anatomic and visual outcomes
What about those phase 3 trials?
In February 2024, Opthea announced enrollment completion for its 2-year, pivotal phase 3 COAST (Combination OPT-302 with Aflibercept Study) program (NCT04757636) trial evaluating intravitreal injections of aflibercept combined with OPT-302 vs aflibercept vs standalone therapy.
Plus: The phase 3 ShORe (Study of OPT-302 in combination with Ranibizumab) program (NCT04757610) is also investigating OPT-302 (2.0 mg) with ranibizumab (0.5 mg).
And when can we expect data?
Opthea reported the following data-readout timelines:
- COAST trial: early Q2 2025
- ShORe: trial: mid-2025