The P-III (OAKS) study evaluated pegcetacoplan (IVI) vs sham in 637 patients with GA. The post hoc analyses of microperimetry data showed a reduction of retinal sensitivity in monthly & EOM with increasing effects over time, slowing GA lesion growth will preserve visual function & patients had fewer new scotomatous points @24mos. & had a favorable safety profile
The rates of infectious endophthalmitis & intraocular inflammation were consistent with reported rates in studies of other IVI therapies & the combined rate of new-onset exudations in monthly, EOM & sham groups (12.2%, 6.7% & 3.1%), respectively
The company plans to submit the MAA to the EMA at the end of 2022. The US marketing application is under Priority Review with an accepted PDUFA date of Nov 2022
Ref: Globenewswire | Image: Apellis
