Product information and disease description Product description Product information

Contraindications/Warnings/Precautions/Adverse effects

6 evidence topics · 6 sources

Warnings and precautions

FDA-approved prescribing information, contraindications, boxed warnings, and REMS

Not applicable.

Key safety findings in the pivotal trial through Week 52

“No treatment-related ocular or systemic serious adverse events were observed.” (opens the source at this quote in a new tab)
“No cases of endophthalmitis, occlusive retinal vasculitis, non-occlusive retinal vasculitis, retinal detachment, or implant migration to the anterior chamber were observed in the AXPAXLI arm.” (opens the source at this quote in a new tab)

Vitreous floaters and relation to hydrogel bioresorption

“Appearance of floaters likely corresponds to hydrogel dissolution and drug elution” (opens the source at this quote in a new tab)
“No evidence of IOI” (opens the source at this quote in a new tab)
“No case observed to be associated with cataract formation” (opens the source at this quote in a new tab)

“For all AXPAXLI subjects with a vitreous floater adverse event reported, drug particles are no longer visible (mean time of 20 weeks).” (opens the source at this quote in a new tab)

Intraocular inflammation

“Nine events observed in study eyes of 7 subjects in the OTX-TKI arm” (opens the source at this quote in a new tab)
“All cases were mild or moderate in severity and resolved” (opens the source at this quote in a new tab)

Injection-procedure endophthalmitis in the U.S. phase 1 trial

“One SAE of endophthalmitis was observed in the AXPAXLI arm which occurred following the aflibercept injection required by the clinical trial protocol at month one and was assessed by the investigator as related to the injection procedure.” (opens the source at this quote in a new tab)

Implant retrieval

“Our hydrogel implants and inserts are designed to fully dissipate and can be removed if necessary by a healthcare professional.” (opens the source at this quote in a new tab)

Class context: retinal vein occlusion with systemic tyrosine kinase inhibitors, including oral axitinib

“Three patients were on imatinib, five patients on axitinib, two on ibrutinib, and one patient on regorafenib.” (opens the source at this quote in a new tab)
“This series highlights a possible association between TKI therapy and RVO, underscoring the need for awareness in patients with vascular risk factors.” (opens the source at this quote in a new tab)