Opthea (OPT) H.C. Wainwright 4th Annual Ophthalmology Virtual Conference summary

Conference overview

• H.C. Wainwright hosted its fourth annual Ophthalmology Conference, featuring presentations and panels accessible via a virtual portal.

• The event included a keynote from Opthea Limited, focusing on advancements in ophthalmology and drug development.

Lead asset and market context

• Sozinibercept aims to be the first new drug in nearly 20 years to improve visual outcomes for wet AMD, a leading cause of vision loss.

• Wet AMD affects 3.5 million patients in the US and Europe, with current anti-VEGF-A therapies leaving significant unmet needs.

• The global wet AMD market exceeds $15 billion, dominated by Eylea, Vabysmo, and Lucentis.

Clinical development and trial results

• Sozinibercept is a first-in-class VEGF-C/D trap, designed for use with any anti-VEGF-A therapy, not as a competitor but as a combination.

• Phase IIb trials showed statistical superiority in vision and anatomical outcomes when combined with Lucentis, especially in hard-to-treat subgroups.

• Two pivotal phase III trials, COAST and SHORE, are fully enrolled, with top-line data expected in Q2 and mid-2025, respectively.

• The trials are powered at 90% and target broad FDA labeling, with primary endpoints focused on best-corrected visual acuity at week 52.