Name: AXPAXLI (axitinib intravitreal implant) in Neovascular age-related macular degeneration: Indication
Published: 2026-09-17T18:54:38-04:00

Product information and disease description Product description Product information

Indication

4 evidence topics · 4 sources

Indication under development

“today announced the successful completion of its Pre-New Drug Application (NDA) Meeting with the U.S. Food and Drug Administration (FDA) for its investigational product candidate AXPAXLI™ (also known as OTX-TKI) for the treatment of wet age-related macular degeneration (wet AMD).” (opens the source at this quote in a new tab)

Label sought by the sponsor

“Based on the SOL-1 trial results, we believe AXPAXLI has the potential to receive a superiority label as compared to a single injection of aflibercept 2 mg, with redosing potentially as infrequently as every 12 months, if approved.” (opens the source at this quote in a new tab)

“We believe the design of the SOL-1 trial enhances the potential for a 6 - 12 month dosing label for AXPAXLI for the treatment of wet AMD and also provides insights into the long-term durability of AXPAXLI.” (opens the source at this quote in a new tab)

Population studied in the pivotal superiority trial

“In December 2024, the trial completed randomization of 344 treatment-naïve subjects with a diagnosis of wet AMD in the study eye. Two randomized subjects withdrew from the trial prior to receiving Day 1 treatment.” (opens the source at this quote in a new tab)

Other indications in development

“AXPAXLI is currently in Phase 3 clinical trials for wet age-related macular degeneration (wet AMD), and diabetic retinal disease, including non-proliferative diabetic retinopathy (NPDR).” (opens the source at this quote in a new tab)