Host: Priya Vakharia, MD

Guest: Andrew Moshfeghi, MD

The SOL-1 Phase 3 superiority trial compared the efficacy and safety of the investigational product OTX-TKI (axitinib intravitreal hydrogel) with aflibercept 2 mg. The primary endpoint was proportion of subjects who maintained visual acuity, defined as <15 Early Treatment Diabetic Retinopathy Study letters of best-corrected visual acuity loss from baseline at Week 36. Based on the findings, SOL-1 met its primary endpoint and demonstrated a statistically significant high proportion of subjects maintained visual acuity with OTX-TKI vs. aflibercept 2 mg at Week 36. OTX-TKI demonstrated stability in vision and anatomic outcomes through 36 weeks, with evidence of extended durability and delayed need for rescue therapy. This could contribute to the goal of maintaining disease control in wet AMD. OTX-TKI was generally well tolerated through Week 52. Ocular adverse events were reported in 52.9% of OTX-TKI-treated subjects vs. 33.7% of aflibercept-treated subjects. There were no treatment-related serious adverse events (SAEs) and no cases of retinal vasculitis. The most common AEs reported in OTX-TKI subjects were vitreous floaters (12.4%), cataract (7.1%) and conjunctival hemorrhage (6.5%).

To learn more about the SOL-1 trial design, findings, and implications for care, tune in to hear Dr. Priya Vakharia speak with Dr. Andrew Moshfeghi.

Reference:

Heier …