Key Takeaways

  • Duravyu 2.7 mg missed the primary noninferiority endpoint versus on-label aflibercept 2 mg in the full LUGANO dataset, but an ad hoc analysis excluding 9 of 211 patients (4%) showed noninferiority (nominal P = .0096).
  • Duravyu 2.7 mg reduced treatment burden by 42% versus aflibercept 2 mg (nominal P < .0001); 76% of patients were supplement-free through week 32 and 54% remained supplement-free through week 56.
  • Among Duravyu-treated patients, 94% received zero or one supplemental injection through week 32 and 79% received zero or one supplemental injection through week 56.

EyePoint announced that Duravyu (vorolanib intravitreal insert) 2.7 mg did not meet the primary endpoint of noninferiority to on-label aflibercept 2 mg in the full dataset of the phase 3 LUGANO trial in wet age-related macular degeneration (AMD), although an ad hoc analysis excluding 9 of 211 Duravyu-treated patients showed noninferiority (nominal P = .0096).

The excluded patients, representing 4% of the Duravyu group, experienced vision loss of 15 or more letters that EyePoint said was unrelated to wet AMD. No patients in the aflibercept 2 mg control arm experienced vision loss of 15 or more letters unrelated to wet AMD. The trial’s primary endpoint was noninferiority in average change from baseline in best-corrected visual acuity (BCVA) at weeks 52 and 56.

Duravyu 2.7 mg reduced treatment burden by 42% versus on-label aflibercept 2 mg, meeting superiority for this secondary endpoint (nominal P < .0001). According to EyePoint, the reduction corresponded to an average of two fewer injections through week 56, compared with a maximum possible reduction of 60%.

Among Duravyu-treated patients, 76% required no supplemental aflibercept through week 32, and 94% received zero or one supplemental injection during that period. Through week 56, 54% remained supplement-free, and 79% received zero or one supplemental injection. In a prespecified analysis of supplement-free patients, Duravyu was noninferior to on-label aflibercept for change in BCVA from baseline to the average of weeks 52 and 56 (nominal P = .0035).

At week 56, the mean difference in central subfield thickness between Duravyu and on-label aflibercept was 4 µm. Among the 54% of Duravyu-treated eyes that remained supplement-free through week 56, the difference was 3 µm compared with the aflibercept control group.

EyePoint reported no differences between groups in cataracts, elevated IOP, or intraocular inflammation and no cases of insert migration, anterior chamber opacities, free-floating drug particles, retinal vasculitis, or severe intraocular inflammation.