WALTHAM -
New data include an analysis from the Phase 3 DERBY and OAKS studies, which showed the mean rate (slope) of GA lesion growth at 18 months with both monthly and every-other-month intravitreal pegcetacoplan, an investigational, targeted C3 therapy for geographic atrophy (GA) secondary to age-related macular degeneration. The results were consistent with previously reported 18-month data, with all p-values (nominal) below 0.05.
'Our presence at ASRS reinforces our leadership in retina and the potential of pegcetacoplan to become the first treatment for GA,' said
Apellis announced the submission of a New Drug Application (NDA) for pegcetacoplan for GA to the
About DERBY and OAKS
DERBY (621 patients enrolled) and OAKS (637 patients enrolled) are Phase 3, multicenter, randomized, double-masked, sham-controlled studies comparing the efficacy and safety of intravitreal pegcetacoplan with sham injections in patients with geographic atrophy (GA) secondary to age-related macular degeneration (
About Geographic Atrophy (GA)
Geographic atrophy (GA) is an advanced form of age-related macular degeneration (
About Pegcetacoplan for Geographic Atrophy (GA)
Pegcetacoplan is an investigational, targeted C3 therapy designed to regulate excessive activation of the complement cascade, part of the body's immune system, which can lead to the onset and progression of many serious diseases. Pegcetacoplan was granted Fast Track designation by the
About Apellis
Apellis Forward-Looking Statement
Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute 'forward-looking statements' within the meaning of The Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements regarding timing of anticipated regulatory actions or submissions. The words 'anticipate,' 'believe,' 'continue,' 'could,' 'estimate,' 'expect,' 'intend,' 'may,' 'plan,' 'potential,' 'predict,' 'project,' 'should,' 'target,' 'will,' 'would' and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including whether the results of the FILLY, DERBY and OAKS trials are sufficient to support regulatory submissions; whether a submission for approval of intravitreal pegcetacoplan for GA on the basis of the FILLY, DERBY and OAKS trials will be accepted by the FDA or foreign regulatory agencies; whether intravitreal pegcetacoplan will receive approval from the FDA or equivalent foreign regulatory agencies for GA when expected or at all and other factors discussed in the 'Risk Factors' section of Apellis' Quarterly Report on Form 10-Q with the
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