WALTHAM -
Data highlights include detailed 24-month results of safety and efficacy as well as exploratory analyses of lesion growth data and photoreceptor changes utilizing artificial intelligence guided image processing.
'Our scientific presence at AAO this year is a testament to our leadership in retina and the potential of pegcetacoplan to become the first treatment for GA, a devastating disease that leads to irreversible vision loss,' said
The
Presentation details
Treatment of Geographic Atrophy Secondary to AMD With Pegcetacoplan: Two-Year Outcomes from the Randomized Phase 3 DERBY and OAKS Trials - RET10 -
The Role of AI-Guided OCT Imaging in Geographic Atrophy - RET19 -
Efficacy of Intravitreal Pegcetacoplan in GA: 24-Month Results from the Phase 3 DERBY and OAKS Trials - PA024 -
Safety of Intravitreal Pegcetacoplan in GA: 24-Month Results from the Phase 3 DERBY and OAKS Trials - PA069 -
e-Poster
Evaluation of Patients with GA Secondary to AMD: Analysis of the Academy IRIS Registry - PO427
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 (AMD). The primary objective of the studies is to evaluate the efficacy of pegcetacoplan in patients with GA assessed by change in the total area of GA lesions from baseline as measured by fundus autofluorescence (p-value less than .05) at 12 months. Patients in DERBY and OAKS received masked treatment for 24 months. All patients who completed the DERBY or OAKS studies were invited to participate in the GALE open-label extension study.
About Geographic Atrophy (GA)
Geographic atrophy (GA) is an advanced form of age-related macular degeneration (AMD) and a leading cause of blindness that impacts more than 5 million people worldwide, including one million people in the United States.1,2 This progressive disease can severely impair visual function, independence, and quality of life as it takes on average 2.5 years for GA lesions to encroach the fovea, which is responsible for central vision.3 GA is caused by destruction of retinal cells through irreversible lesion growth that is driven by excessive complement activation.4 C3 is the only target that can precisely control the complement cascade due to its central location. There are currently no approved treatments for GA.
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 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' Annual Report on Form 10-K with the
Contact:
Tel: 617.977.6764
Email: media@apellis.com
(C) 2022 Electronic News Publishing, source