Product information and disease description Place of product in therapy Approaches to treatment

Heterogeneity of treatment effect

8 evidence topics · 6 sources

Stratification by baseline visual acuity in SOL-1

“In addition, the subjects were stratified between the two treatment groups at randomization based on BCVA category (≤ 71 and >71 ETDRS letters) as of the initial screening visit.” (opens the source at this quote in a new tab)

Distribution of the SOL-1 population across the stratification category

“>71 letters (~ 20/40)*, n (%) 145 (85.3) 136 (79.1)” (opens the source at this quote in a new tab)

Visual acuity outcomes by screening BCVA quartile: post hoc analysis

“The magnitude of vision improvements was influenced by BCVA at screening. For example, AXPAXLI subjects in the lowest vision quartile group at screening had the greatest visual gains with +11.8 ETDRS letters compared to +8.5 letters in the aflibercept (2 mg) arm at Week 52.” (opens the source at this quote in a new tab)
“In comparison, subjects in the best vision quartile at screening had essentially no change in vision at Week 52 (-0.5 vs +1.1 letters; AXPAXLI vs aflibercept) as they started with almost 20/20 vision.” (opens the source at this quote in a new tab)

Outcomes restricted to rescue-free participants: post hoc analysis

“Observed difference for change in BCVA from baseline at Week 24 in the rescue-free subjects was -1.9 ETDRS letters in the AXPAXLI arm (+7.5 letters from screening) vs -2.6 letters in the aflibercept arm (+6.0 letters from screening).” (opens the source at this quote in a new tab)

Rescue criteria as a source of variation in estimated durability

“In a prespecified exploratory analysis applying the SOL-R protocol rescue criteria to the SOL-1 results, AXPAXLI demonstrated a 77.1% rescue-free rate at Week 24.” (opens the source at this quote in a new tab)

Enriched SOL-R population and expected differences in response

“We expect these rescue-free rates to be even higher in populations such as the one randomized in SOL-R, given SOL-R’s patient enrichment strategy over the six months prior to randomization that excluded subjects with early persistent fluid or significant fluid fluctuations.” (opens the source at this quote in a new tab)

Differences between phase 1 populations

“The population we studied in this U.S.-based clinical trial was different than the population we studied in our Phase 1 clinical trial of AXPAXLI in Australia.” (opens the source at this quote in a new tab)
“In this trial, we evaluated how long we are able to maintain subjects who have been previously treated with anti-VEGF therapy without the need for retreatment.” (opens the source at this quote in a new tab)

Baseline vision of SOL-1 compared with other nAMD trial populations

“mean BCVA: 81 letters (~20/25)” (opens the source at this quote in a new tab)
“mean BCVA: 52 to 62 letters” (opens the source at this quote in a new tab)

Subgroup efficacy results by age, sex, race or ethnicity, lesion type, or baseline fluid

No evidence found.