Duravyu (vorolanib intravitreal insert)

In the phase 3 LUGANO trial (432 participants; vorolanib insert 2.7 mg every 6 months versus aflibercept 2 mg every 8 weeks), the vorolanib insert did not achieve noninferiority for mean change in best-corrected visual acuity at weeks 52 and 56 in the full dataset. An ad hoc analysis excluding 9 of 211 insert-arm participants met the noninferiority criterion (nominal p = 0.0096). Relative to on-label aflibercept, the insert reduced treatment burden by 42% (nominal p < 0.0001), about 2 fewer injections through week 56. Of insert-treated participants, 76% were supplement-free through week 32, 54% through week 56, and 79% received zero or one supplemental injection through week 56. The mean difference in central subfield thickness versus aflibercept was 4 microns at week 56. Rates of cataract, elevated intraocular pressure, and intraocular inflammation did not differ between arms. In the phase 2 DAVIO 2 trial of previously treated participants, the 2 mg and 3 mg doses differed from aflibercept by -0.3 and -0.4 letters, respectively, at weeks 28 and 32, and 65% and 64% of eyes were supplement-free through 6 months. All data are topline or preliminary sponsor reports. LUCIA results are pending.