MedPath

Avacincaptad pegol

Generic Name
Avacincaptad pegol
Brand Names
Izervay
Drug Type
Biotech
Chemical Formula
-
CAS Number
1613641-69-2
Unique Ingredient Identifier
TT0V5JLG5B
Background

Avacincaptad pegol is an RNA aptamer covalently bound to a branched polyethylene glycol (PEG) molecule. It was developed to treat an advanced form of age-related macular degeneration (AMD) called geographic atrophy (GA). AMD is the leading cause of vision loss in developed countries for people over 50 years old, with a global estimate of 170 million individuals affected. AMD eventually progresses to bilateral and irreversible loss of vision, whether or not the patients have the non-neovascular (dry) or the neovascular (wet) form of AMD. Although anti-VEGF therapy is available for the neovascular form of AMD, no treatment was approved for GA.

Avacincaptag pegol was approved by the FDA on August 4, 2023, under the brand name IZERVAY for the treatment of GA secondary to AMD. This approval is based on the positive results obtained from 2 phase 3 clinical trials GATHER1 and GATHER2.

Indication

Avacincaptad pegol is indicated for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD).

Associated Conditions
Dry Macular Degeneration
Associated Therapies
-
Clinical Trials
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Enrollment complete of phase 2b of SIGLEC study to assess safety and efficacy of AVD-104

Aviceda Therapeutics has completed enrollment for the phase 2b SIGLEC Study, assessing AVD-104's safety and efficacy in treating geographic atrophy (GA) secondary to age-related macular degeneration (AMD). The study compares high- and low-dose AVD-104 with avacincaptad pegol, with 100 patients enrolled in each arm. AVD-104, an optimized intravitreal glycomimetic nanoparticle, aims to inhibit macrophage and complement cascade amplification. The 12-month data is expected in the second half of 2025.
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Aviceda Completes Enrollment for Phase 2b SIGLEC Study for Geographic Atrophy Treatment

Aviceda Therapeutics completed enrollment for its phase 2b SIGLEC study, comparing AVD-104 with Izervay for geographic atrophy treatment. The study, involving 300 patients, aims to assess GA lesion growth rate differences at 12 months. AVD-104 showed promise in phase 2a, with reduced GA progression and improved visual outcomes.
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Aviceda begins part 2 of Phase II/III trial for geographic atrophy

Aviceda Therapeutics has initiated Part 2 of the Phase II/III SIGLEC trial for AVD-104, targeting geographic atrophy (GA) secondary to AMD. This phase compares AVD-104's efficacy and safety against avacincaptad pegol over 12 months, with an optional 12-month extension. Part 1 showed AVD-104's safety and BCVA improvements at 3 months. The trial aims to explore AVD-104's dual-mechanism approach against GA, potentially shifting treatment paradigms.
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Aviceda reports topline data from SIGLEC trial for GA

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Related Clinical Trials:

A Multiple Dose Study of AVD-104 for Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (AMD)
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Aviceda Therapeutics Announces Topline Data from Part 1 of the Phase 2/3 SIGLEC Trial for Geographic Atrophy Secondary to AMD

AVD-104 showed positive safety and efficacy in Part 1 of the Phase 2/3 SIGLEC trial for geographic atrophy (GA) secondary to AMD, with significant visual improvement and reduced GA lesion growth observed at 3 months post-injection. Part 2, a double-masked, randomized trial, will compare AVD-104 with an active comparator, enrolling 300 patients for 12 months, aiming to demonstrate AVD-104's superiority in GA treatment.
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FDA Approves Avacincaptad Pegol for Geographic Atrophy

The FDA approved avacincaptad pegol (IZERVAY) for treating geographic atrophy (GA) in age-related macular degeneration (AMD), targeting the C5 pathway. Supported by phase 3 trials, it showed a 17.7% reduction in GA area growth over 12 months, with no major adverse events. This approval offers hope for slowing GA progression and preserving vision.
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