Product information and disease description Product description Product information

Dosage forms and strengths

5 evidence topics · 3 sources

Dosage form: polyethylene glycol hydrogel containing micronized axitinib

“Our intravitreal hydrogel product candidates, such as AXPAXLI, consist of a PEG-based hydrogel, which contains embedded micronized particles of” (opens the source at this quote in a new tab)

“OTX-TKI is a dried polyethylene glycol-based hydrogel fiber containing dispersed microcrystals of a small molecule tyrosine kinase inhibitor (TKI).” (opens the source at this quote in a new tab)

Strength in phase 3 trials: 450 µg (0.45 mg), second-generation formulation

“We are currently conducting the SOL-1, SOL-R and HELIOS-3 trials, and we plan to conduct the SOL-X trial and, if needed, the HELIOS-2 trial with a 450 µg axitinib dose of AXPAXLI, or AXPAXLI 450 µg, which is a different formulation than we used in either of the two Phase 1 trials of AXPAXLI that we have completed for the treatment of wet AMD.” (opens the source at this quote in a new tab)
“This optimized configuration provides for an increased daily release of the drug and improved synchronization of axitinib drug release with hydrogel bioresorption.” (opens the source at this quote in a new tab)

Second-generation formulation: more soluble form of axitinib

“Optimized in same hydrogel but with a more soluble form of axitinib, delivering the targeted daily release rate in a 0.45-mg dose” (opens the source at this quote in a new tab)

Strengths studied in phase 1 trials: first-generation 200, 400, and 600 µg implants

“In the clinical trial, intravitreal injections of AXPAXLI at 200 μg, 400 μg, and 600 μg, with and without concurrent administration of anti-VEGF, were generally well tolerated.” (opens the source at this quote in a new tab)

Delivery device: single-use applicator

“IVT administration with single-use applicator (25G needle)” (opens the source at this quote in a new tab)

Commercial presentation, packaging, and storage conditions

No evidence found.