After announcing earlier this week the appointment of Andreas Wallnöfer, PhD, MBA, to its Board of Directors, Optigo Biotherapeutics is also preparing to advance its lead retinal program, XPK-640, toward Investigational New Drug (IND)-enabling studies.^1,2

To learn more, The Eye Care Network spoke with Harpal Sandhu, MD, FRCSC, to discuss the preclinical data behind Optigo’s platform and how these findings are shaping early clinical development. Sandhu outlines how the platform’s extended durability, driven by its hyaluronic acid-anchoring design, may influence future therapeutic expectations for patients with neovascular retinal disease. Sandhu is in private practice with Retina Northwest, and clinical instructor in ophthalmology at Oregon Health and Science University in Portland.

Note: Transcript edited lightly for clarity and length.

Can you elaborate on the preclinical pharmacology and toxicology studies for Optigo’s platform, and how these data support the IND-enabling package?

Sandhu: Preclinical studies in non-human primates suggest that Optigo’s lead molecule, XPK-640, may deliver a dramatic increase in durability compared with current anti-VEGF therapies. The compound maintained therapeutic levels in the eye for 29 to 50 days—roughly 20 times longer than aflibercept—and was well tolerated with no detectable systemic exposure. These findings support advancement into IND-enabling toxicology studies and underscore the molecule’s potential to reduce the need for frequent intravitreal injections.

How does the vitreous-anchoring mechanism of the bispecific anti-VEGF molecules influence ocular pharmacokinetics and tissue retention compared with current standard-of-care therapies?

Sandhu: Optigo’s bispecific anti-VEGF design incorporates a vitreous-anchoring mechanism intended to enhance ocular residence time. In primate models, the approach sustained drug levels for up to 12 months following a single injection—substantially longer than standard anti-VEGF agents or implant-based delivery systems. The data suggest that the platform could offer unmatched durability while maintaining the safety and simplicity of a routine intravitreal injection.

What were the critical efficacy end points observed in the VEGF challenge models, and how do these findings inform projected dosing intervals in humans?

Sandhu: In rabbit VEGF challenge models, XPK-640 delayed vascular leakage approximately 4-fold relative to [aflibercept], consistent with a 5-fold extension in ocular half-life. When combined with non-human primate pharmacokinetic data, the results point toward a potential dosing interval of up to 12 months in humans, offering a pathway to longer-lasting vision stability and fewer treatment visits for patients.

From a translational perspective, how do the preclinical results guide your strategy for clinical development, including anticipated benefits in treatment durability and patient compliance?

Sandhu: The preclinical pharmacokinetic profile of XPK-640 has guided Optigo’s upcoming first-in-human trial in treatment-naïve wet AMD. The study will proceed without loading doses to evaluate whether a single injection can maintain retinal drying and vision improvements over a 48-week period. Early data suggest that many patients could remain injection-free for 6 months or longer, a shift that could significantly lessen treatment burden and improve adherence in chronic retinal disease.

Harpal Sandhu, MD, FRCSC
E: [email protected]
Sandhu is in private practice with Retina Northwest, and clinical instructor in ophthalmology at Oregon Health and Science University in Portland. Sandhu serves on the scientific advisory board for Optigo Biotherapeutics.

REFERENCES

1. Renowned pharma and biotech development leader, Dr. Andreas Wallnöfer, is named to Optigo Biotherapeutics’ Board of Directors as the company advances to IND-enabling studies. News release. November 4, 2025. Accessed November 5, 2025. https://www.optigobio.com/press-release-2025-11-04

2. Optigo Biotherapeutics wins People’s Choice Award at Eyecelerator and presents compelling preclinical data on long-acting intravitreal biologics at the ARVO 2025 conference. News release. May 6, 2025. Accessed November 5, 2025. https://www.optigobio.com/press-release-2025-05-06