Trial Profile
A Phase II, Multicenter, Randomized, Single-Masked, Sham-Controlled Study of Safety, Tolerability and Evidence of Activity of Intravitreal APL-2 Therapy in Patients With Geographic Atrophy (GA)
Status:
Completed
Phase of Trial:
Phase II
Latest Information Update: 20 Sep 2023
Price :
$35
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At a glance
- Drugs Pegcetacoplan (Primary)
- Indications Dry age-related macular degeneration; Dry macular degeneration
- Focus Adverse reactions; Therapeutic Use
- Acronyms FILLY
- Sponsors Apellis Pharmaceuticals
- 16 Sep 2023 Results (n=144) patients with bilateral geographic atrophy, evaluating the effect pegcetacoplan on the rate of progression of geographic atrophy (GA) as assessed by spectral domain optical coherence tomography (SD-OCT) using a split-person study design and deep-learning quantification, published in the Ophthalmology and Therapy
- 19 Jul 2022 According to an Apellis Pharmaceuticals media release, the U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review designation for the intravitreal pegcetacoplan New Drug Application (NDA).The Prescription Drug User Fee Act (PDUFA) target action date is November 26, 2022. The FDA has stated that it is not currently planning to hold an advisory committee meeting to discuss the application.
- 14 Jul 2022 According to an Apellis Pharmaceuticals media release, data from the study will be highlighted at the American Society of Retina Specialists Annual Scientific Meeting(ASRS).