Safety and Clinical Implications of OTX-TKI in Neovascular AMD

Dr. Khanani reviews 52-week safety outcomes, noting Axpaxli was generally well tolerated with no cases of endophthalmitis or retinal vasculitis. All inflammation events were mild to moderate, vasculitis-negative, and resolved with topical therapy. Vitreous floaters occurred more frequently (12.4% vs. 1.2% with aflibercept), likely reflecting hydrogel dissolution during drug release around weeks 30–36, with no impact on vision, cataract formation, or inflammation risk. He then integrates the full dataset, emphasizing sustained visual acuity maintenance, strong anatomic control, and reduced need for rescue treatment alongside a manageable safety profile. Axpaxli is positioned as a first-in-class tyrosine kinase inhibitor with extended durability of 9–12 months, addressing real-world undertreatment in neovascular AMD. He concludes by noting SOL-1’s unique FDA SPA design, emphasizing that its outcomes should be interpreted within a regulatory trial framework rather than standard clinical practice expectations.

This video series has been produced independently by Ophthalmology Times and supported by Ocular Therapeutix. The following presentation discusses OTX-TKI - an investigational product candidate that has not been approved by the FDA or any other regulatory body