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
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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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Jeito Capital announces significant participation in Aviceda Therapeutics' $207.5M Series C financing for AVD-104's Phase 2b/3 and Phase 3 trials in geographic atrophy due to AMD

Jeito Capital leads a $207.5M Series C financing in Aviceda Therapeutics for AVD-104's Phase 2b/3 and Phase 3 trials in geographic atrophy due to AMD. AVD-104, with a dual mechanism targeting immune modulation and complement inhibition, shows promise in slowing GA progression. Data expected in 2025.
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FDA says no to Astellas' geographic atrophy drug

Astellas received a complete response letter from the FDA for Izervay's label update, including GATHER2 trial results, aiming to enhance its competitive profile against Syfovre. This follows the withdrawal of Izervay's EU marketing application. Izervay, approved in the US for GA secondary to AMD, showed benefits with extended dosing in GATHER2. Astellas is seeking clarification from the FDA on the statistical matter preventing approval.
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FDA Wraps Up 2024 Handing Out Several Notable Regulatory Decisions

The FDA made significant regulatory decisions, including the first drug approval for obstructive sleep apnea, a novel regenerative medicine for trauma patients, and treatments for rare diseases and cancer. Notable approvals include Eli Lilly’s Zepbound, Ionis Pharmaceuticals’ Tryngolza, and Humacyte’s Symvess. The FDA also expanded uses for existing drugs and issued rejections and warnings for others.
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Healthy SA: Understanding Geographic Atrophy

Geographic atrophy (GA), an advanced form of dry macular degeneration, causes vision loss from retinal cell death, potentially leading to permanent impairment. Affecting 1.5 million in the U.S., many remain undiagnosed. Symptoms include washed-out colors, night vision difficulty, and central vision loss. Izervay, a monthly eye injection, shows promise in slowing GA progression.
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2024 saw ophthalmology breakthroughs with FDA approvals for home OCT devices, AI for diabetic retinopathy screening, and novel therapies like clobetasol propionate eye drops. Advances in gene therapy for nAMD and retinitis pigmentosa, along with new treatment modalities, underscored a patient-centric approach to vision care.
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Aviceda Therapeutics Advances in Clinical Trials for AVD-104 Targeting Geographic Atrophy

Aviceda Therapeutics progresses in clinical trials for AVD-104, a novel glyco-mimetic nanoparticle, targeting geographic atrophy (GA) secondary to age-related macular degeneration (AMD). Key milestones include completing enrollment for Phase 2b SIGLEC study, presenting positive safety and efficacy data, and strategic partnerships enhancing glyco-immune therapeutic development.
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FDA News Month in Review: November 2024

November 2024 FDA updates include approval of VARIPULSE for atrial fibrillation, removal proposal for oral phenylephrine in nasal decongestants, CRL for Ocaliva in PBC, acceptance of pz-cel gene therapy BLA for RDEB, approval of Emrosi for rosacea, acceptance of dupilumab sBLA for CSU, CRL for IZERVAY in GA, Gildeuretinol for Stargardt disease receiving Rare Pediatric and Fast Track status, approval of bimekizumab for HS, acceptance of HLX14 biosimilar BLA for denosumab, approval of Attruby for ATTR-CM, and acceptance of vutrisiran sNDA for ATTR-CM.
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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.
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