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
Related News
hcplive.com
·

FDA Accepts Revised Avacincaptad Pegol sNDA for Geographic Atrophy

The FDA accepted Astellas Pharma's revised sNDA for avacincaptad pegol (IZERVAY) to treat GA secondary to AMD, setting a February 26, 2025, action date. Initially approved in August 2023, it's the second GA treatment, showing significant GA slowing in Phase 3 trials. Astellas addresses FDA feedback, aiming to include new GATHER2 data.
ophthalmologytimes.com
·

Aviceda Therapeutics completes $207.5 million Series C financing in support of AVD-104 for geographic atrophy treatment

Aviceda Therapeutics raised $207.5M in Series C funding for AVD-104's phase 2b/3 and planned phase 3 trials in geographic atrophy. The study compares AVD-104 doses with avacincaptad pegol, focusing on safety, efficacy, and GA area growth rate. Data expected in late 2025. New board members from Omega Funds and TCGX announced.
markets.businessinsider.com
·

FDA Accepts Astellas Pharma's Revised SNDA For IZERVAY In Geographic Atrophy Treatment

Astellas Pharma announced FDA's acceptance of the revised sNDA for IZERVAY for GA treatment on January 6, 2025, following a December 2024 meeting. Designated as a Class 1 resubmission, it has a 60-day review period, with a target action date of February 26, 2025. IZERVAY, approved in August 2023, seeks to update its prescribing information with 2-year data from the GATHER2 trial.
ground.news
·

FDA Fast-Tracks Astellas Pharma's IZERVAY Eye Treatment

FDA accepted Astellas Pharma's revised sNDA for IZERVAY, highlighting positive 2-year trial data for geographic atrophy treatment, with a decision anticipated by Feb 26.
stocktitan.net
·

FDA Fast-Tracks Astellas Pharma's IZERVAY Eye Treatment Update with 60-Day Review

Astellas Pharma Inc. announced the FDA accepted the revised sNDA for IZERVAY™ for treating geographic atrophy secondary to AMD, with a target action date of February 26, 2025. The sNDA aims to include 2-year data from the GATHER2 trial. IZERVAY, approved in 2023, is an eye injection for GA, with potential side effects including eye infections and increased eye pressure.

Related Clinical Trials:

A Phase 3 Safety and Efficacy Study of Intravitreal Administration of Zimura (Complement C5 Inhibitor)
prnewswire.com
·

U.S. FDA Confirms Class 1 Resubmission of the Revised sNDA for IZERVAY™ for GA Secondary to AMD

Astellas Pharma Inc. announced the FDA accepted the revised sNDA for IZERVAY™ for GA secondary to AMD, with a target action date of February 26, 2025. The sNDA aims to include 2-year data from the GATHER2 Phase 3 trial. IZERVAY, approved in 2023, treats GA, a severe form of dry AMD, with potential side effects including eye infections and increased eye pressure.

Related Clinical Trials:

A Phase 3 Safety and Efficacy Study of Intravitreal Administration of Zimura (Complement C5 Inhibitor)
pharmaphorum.com
·

Aviceda raises $207.5m for eye drug, and other financings

Aviceda Therapeutics raised $207.5M for AVD-104's phase 2/3 SIGLEC trial in geographic atrophy, aiming to improve treatment efficacy. Other biotech financings include Orbis Medicines' €90M Series A, Alebund Pharmaceutical's RMB 550M round, XyloCor Therapeutics' $67.5M Series B, and PrimeGene's RMB 300M second round for various drug developments.
finance.yahoo.com
·

Aviceda Therapeutics Raises Upsized $207.5 Million in Series C Financing to Advance AVD-104 for Geographic Atrophy

Aviceda Therapeutics closed a $207.5M Series C financing to advance AVD-104, a treatment for geographic atrophy, into pivotal trials. The funding, led by Omega Funds and TCGX, supports ongoing Phase 2b/3 trials, with 12-month data expected in late 2025. AVD-104 targets immune modulation and complement inhibition, showing promise in slowing disease progression.
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