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
optometrytimes.com
·

What happened in optometry this week: November 18 - November 22

US FDA issues Complete Response Letter for avacincaptad pegol (IZERVAY) due to a statistical matter; Aldeyra Therapeutics' NDA for reproxalap for dry eye accepted by FDA; case report on carotid-cavernous fistula misdiagnosed as allergies; AAOpt 2024 discusses genetic testing; study links long-term blood pressure variability to visual field progression in glaucoma.
hcplive.com
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FDA Issues CRL to Avacincaptad Pegol sNDA for Geographic Atrophy

FDA issued a Complete Response Letter for Astellas Pharma's sNDA of avacincaptad pegol for geographic atrophy secondary to AMD, citing a statistical labeling issue. Astellas remains committed to addressing FDA feedback and advancing GA treatments.
consultantlive.com
·

FDA Issues CRL to Avacincaptad Pegol sNDA for Geographic Atrophy Treatment

The FDA issued a Complete Response Letter for Astellas Pharma's sNDA for avacincaptad pegol, citing statistical concerns in labeling. Approved in 2023 for GA secondary to AMD, the drug showed efficacy in Phase 3 trials. Astellas plans to address FDA feedback, emphasizing commitment to GA treatment advancements.
ophthalmologytimes.com
·

FDA issues CRL to Astellas' Supplemental New Drug Application for avacincaptad pegol

The FDA issued a Complete Response Letter for Astellas Pharma's IZERVAY, citing a statistical issue in proposed labeling language. The CRL does not concern safety or efficacy. Astellas plans to collaborate with the FDA to address the feedback.
biopharmadive.com
·

Astellas application rejected by FDA; Cytokinetics strikes licensing deal with Bayer

Astellas' request to update Izervay's prescribing info rejected by FDA; Jupiter Bioventures, co-founded by Norman Sharpless and Nathaniel David, launches with $70M to create biotech startups; Bayer pays Cytokinetics $53M for aficamten licensing in Japan; Neurogene continues Rett syndrome gene therapy trial at lowest dose after side effects; Cybin's stock dips despite positive Phase 2 data for CYB003; Novartis licenses radiopharmaceutical from Ratio Therapeutics, targeting SSTR2 protein.

Related Clinical Trials:

A Study of a Psilocybin Analog (CYB003) in Healthy Participants With and Without Major Depressive Disorder
europe.ophthalmologytimes.com
·

US FDA issues Complete Response Letter for avacincaptad pegol (IZERVAY, Astellas Pharma Inc)

The FDA issued a Complete Response Letter to Astellas Pharma Inc. for IZERVAY, citing a statistical issue in proposed labelling language, not safety or efficacy. Astellas plans to work with the FDA to address the feedback.
nature.com
·

Artificial intelligence in assessing progression of age-related macular degeneration

modernretina.com
·

New treatment options provide effective management of geographic atrophy

Ferhina S. Ali, MD, MPH, discusses managing geographic atrophy (GA) by considering treatment timing, imaging, phase 3 trial data, and patient adherence. Ali uses an individual treatment approach, focusing on the eye with better vision in bilateral GA cases. She administers GA treatments pegcetacoplan and avacincaptad pegol every 4-6 weeks, guided by trial extension data and patient motivation. Ali emphasizes the importance of monitoring for choroidal neovascularization and progressive vision loss, and ongoing patient education.
optometrytimes.com
·

Preserving vision by detecting and treating GA

Steve Ferrucci, OD, FAAO, emphasized early detection of geographic atrophy (GA) through multimodal imaging and the importance of referring patients with extrafoveal lesions or hyperfluorescence around lesions promptly. New FDA-approved medications, Syfovre and Izervay, can slow GA progression by 25-35%, preserving usable vision. Ferrucci stressed the urgency of recognizing GA now that treatments are available, as vision loss can occur rapidly once lesions start growing.
modernretina.com
·

GA therapies coming down the pike

Katherine Talcott, MD, discusses potential therapies for geographic atrophy (GA) secondary to age-related macular degeneration (AMD) at OSN New York 2024, highlighting ANX007, Danicopan ALXN 2040, AVD-104, JNJ-1887, ASP7317, RG6501, elamipretide, Glideuretinal, AREDS/AREDS2, and ONL1204. ANX007 showed significant protection from vision loss in the ARCHER Trial, while Danicopan ALXN 2040 is an oral agent inhibiting complement factor D. AVD-104 demonstrated visual acuity gains in the SIGLEC study. Gene therapies like JNJ-1887 and ASP7317 aim to protect retinal cells. Elamipretide showed positive effects on visual function in the ReCLAIM study. Glideuretinal and AREDS/AREDS2 are antioxidants, and ONL1204 is a Fas inhibitor reducing retinal cell apoptosis.

Related Clinical Trials:

A Study of Danicopan in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration
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