The Retina TL;DR with Dr. Weng: Moving beyond anti-VEGF with OTX-TKI and Pravin U. Dugel, MD

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In this latest episode of The Retina TL;DR, powered by Modern Retina, host Christina Y. Weng, MD, MBA, FASRS, professor and the Alice R. McPherson Retina Research Foundation Chair in Ophthalmology at Baylor College of Medicine in Houston, Texas, welcomes Pravin U. Dugel, MD, for a discussion on OTX-TKI (AXPAXLI; Ocular Therapeutix), a novel tyrosine kinase inhibitor (TKI) platform currently at a pivotal stage of development for neovascular age-related macular degeneration (AMD). Dugel is executive chairman, president, and CEO of Ocular Therapeutix.

When asked to summarize the TKI program in a “TL;DR” (“too long; didn’t read”), Dugel explained, “With OTX-TKI, what we're trying to do is to solve two problems: one is that of sustainability and the other of chronic long-term outcomes.” He highlighted that while anti-VEGF therapies have transformed care, their pulsatile delivery may contribute to fibrosis and atrophy over time, underscoring the need for more consistent VEGF suppression.

A tunable platform for durability

OTX-TKI combines a potent, selective TKI targeting VEGF receptors with a customizable hydrogel delivery system. This “combination of the two” allows clinicians to tailor durability, with the goal of achieving dosing intervals aligned with real-world practice. Dugel noted that an ideal therapy would last 9 to 10 months, supporting a practical 6-month follow-up cadence while maintaining disease control.

Clinical trial design and regulatory strategy

The phase 3 SOL-1 trial employs an unconventional superiority design guided by FDA input. Patients receive loading aflibercept injections and are then randomized to either aflibercept or a single OTX-TKI implant, with retreatment based on rescue criteria. Addressing concerns about allowing vision decline, Dugel explained, “This is exactly what the FDA wanted…for a pure scientific outcome,” adding that vision loss is limited and comparable to a treat-and-extend approach. (Update: Ocular Therapeutics recently reported that SOL-1 met its primary end point.¹)

The complementary SOL-R trial follows a more traditional noninferiority design, comparing OTX-TKI with standard-of-care aflibercept while incorporating a third arm with high-dose aflibercept for masking and benchmarking. Together, the trials aim to answer key clinical and commercial questions, from durability to repeatability and comparative efficacy.

Looking ahead

With both trials fully enrolled and a special protocol agreement in place, OTX-TKI may pursue a streamlined regulatory pathway, potentially enabling approval based on SOL-1 alone.¹ Dugel expressed confidence in the program’s trajectory and broader impact, noting that scalable therapies like this could extend treatment reach beyond what is possible in individual clinical practice.

Additional resources

For retina specialists seeking additional details, Dugel encouraged visiting the company’s website, noting that it contains “a whole plethora of information,” including downloadable resources, presentations, and materials accessible through tabs such as the Investor section.

Christina Y. Weng, MD, MBA, FASRS, is professor and the Alice R. McPherson Retina Research Foundation Chair in Ophthalmology, and fellowship program director, vitreoretinal diseases and surgery with Baylor College of Medicine in Houston, Texas. Weng is a consultant for EyePoint Pharmaceuticals and Ocular Therapeutix.

Pravin U. Dugel, MD, is executive chairman, president, and CEO of Ocular Therapeutix.

REFERENCE

1. Ocular Therapeutix reports positive results from landmark SOL-1 phase 3 superiority trial in wet AMD. News release. Ocular Therapeutix. February 17, 2026. Accessed March 20, 2026. https://investors.ocutx.com/news-releases/news-release-details/ocular-therapeutixtm-reports-positive-results-landmark-sol-1