Request Demo

Last update 24 May 2025

Avacincaptad pegol

Last update 24 May 2025

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

RNA aptamer

Synonyms

Anti-C5 aptamer, Avacincaptad pegol sodium (USAN), Zimura

+ [5]

Target

Action

inhibitors

Mechanism

C5 inhibitors(Complement C5 inhibitors)

Therapeutic Areas

Congenital DisordersEye DiseasesNervous System Diseases+ [1]

Active Indication

Geographic AtrophyAge Related Macular DegenerationBlindness+ [3]

Inactive Indication

Idiopathic Polypoidal Choroidal VasculopathyWet age-related macular degeneration

Originator Organization

Ocular Therapeutix, Inc.

Active Organization

IVERIC bio, Inc.

Astellas Pharma, Inc.Astellas Pharma Global Development, Inc.

+ [3]

Inactive Organization

Ophthotech Corp. (New Jersey)

License Organization

DelSiTech Oy

Astellas Pharma, Inc.

Archemix Corp.

+ [1]

Drug Highest PhaseApproved

First Approval Date

United States (04 Aug 2023),

Geographic Atrophy

RegulationBreakthrough Therapy (United States), Priority Review (United States)

Structure/Sequence

Boost your research with our RNA technology data.

view full example data

Sequence Code 29451050

Source: *****

Clinical Trials associated with Avacincaptad pegol

NCT06961370

/ RecruitingPhase 1

A Phase I, Multi-center, Multi-part Study to Investigate Safety, Tolerability, PK, PD, and Immunogenicity of RO7669330 Intravitreal Injections in Participants With GA Secondary to AMD: Part 1A: Open-label, MAD; Part 1B: Randomized PD Pilot; Part 2: Masked, Randomized, Active-comparator-controlled

The main purpose of this study is to assess the ocular and systemic safety and tolerability of RO7669330 in GA secondary to AMD after multiple unilateral intravitreal (IVT) doses.

Start Date21 May 2025

Sponsor / Collaborator

Roche Holding AG

NCT06970665

/ Not yet recruitingPhase 3

A Phase 3/4, Multicenter, Single-arm Clinical Study to Assess the Safety of Intravitreal Administration of ASP3021 in Participants in Japan With Geographic Atrophy Secondary to Age-related Macular Degeneration

Age-related macular degeneration (AMD) is an eye disease which causes people to lose their vision over time. AMD damages the macula, which is in the middle of the retina - the light sensitive part at the back of the eye. In AMD, the cells in the macula die over time, usually over several years, leading to vision loss. When AMD gets worse, it can turn into either geographic atrophy (GA), neovascular AMD, or both.
This study is for people in Japan of 40 years of age or older, who have geographic atrophy.
The main aim of this study is to collect information about the safety of ASP3021 and how well people tolerate treatment with ASP3021.
During the study, people will receive monthly injections of ASP3021 for 12 months. ASP3021 is given by injection into the affected eye. This procedure is called an intravitreal injection.
People will be in the study for about 1 year. People will visit their study clinic several times for health checks.

Start Date19 May 2025

Sponsor / Collaborator

Astellas Pharma, Inc.

NCT06779773

/ RecruitingNot Applicable

A Non-interventional, Observational Study to Evaluate Treatment Patterns and Safety of Avacincaptad Pegol (ACP/IZERVAY™) in Routine Clinical Practice in Patients With Geographic Atrophy Secondary to Age-related Macular Degeneration

This study is for people who have geographic atrophy due to age-related macular degeneration (AMD). AMD happens when the macula, the light-sensitive layer at the back of the eye called the retina, becomes damaged and causes a person's central vision to worsen. Geographic atrophy is an advanced form of AMD where cells in the retina waste away and die. Over time this can lead to permanent loss of vision.
Avacincaptad pegol can help slow down the worsening or progression of geographic atrophy. Avacincaptad pegol is a treatment approved in the US to treat geographic atrophy.
This study is about collecting information on how people with geographic atrophy are treated in routine clinical practice. This includes recording any medical problems from avacincaptad pegol. This is known as an observational study. Information will be collected from the peoples' medical records during and after treatment. The people in this study will have geographic atrophy in 1 or both eyes and they and their doctor has decided they will be treated with avacincaptad pegol. The individual's doctor decides on treatment, not the study sponsor (Astellas).
People that want to take part in the study will have eye examinations that they would usually have as part of their routine care. People will also be asked to complete surveys about their eye health. These surveys will occur when treatment starts and then every 6 months for the first 2 years. After 2 years the surveys will happen once a year. The people on the study can take part if their doctor provides treatment with avacincaptad pegol and they want to continue with the study. The people on the study can take part for up to 3 years or up to 5 years, depending on when they start the study.

Start Date22 Jan 2025

Sponsor / Collaborator

Astellas Pharma Global Development, Inc.

100 Clinical Results associated with Avacincaptad pegol

100 Translational Medicine associated with Avacincaptad pegol

100 Patents (Medical) associated with Avacincaptad pegol

Literatures (Medical) associated with Avacincaptad pegol

01 Aug 2025·AMERICAN JOURNAL OF OPHTHALMOLOGY

Ocular Adverse Events Associated with Pegcetacoplan and Avacincaptad Pegol for Geographic Atrophy: A Population-Based Pharmacovigilance Study

Article

Author: Kertes, Peter J ; Muni, Rajeev H ; Popovic, Marko M ; Mihalache, Andrew ; Kailani, Zeena

OBJECTIVE:

To evaluate the postmarketing ocular adverse events (AEs) reported for avacincaptad pegol and pegcetacoplan, the only Food and Drug Administration (FDA)-approved treatments for geographic atrophy (GA).

DESIGN:

Retrospective pharmacovigilance analysis.

SUBJECTS:

Ocular AE reports in the FDA Adverse Event Reporting System (FAERS) in which pegcetacoplan or avacincaptad pegol was identified as the primary suspect drug were analyzed.

METHODS:

Using the OpenVigil 2.1 data mining software, we conducted a retrospective pharmacovigilance analysis of the FAERS database from inception to December 2024. We conducted disproportionality analyses to assess reporting odds ratios (RORs) for specific drug-AE combinations compared with all other drugs in the database.

MAIN OUTCOME MEASURES:

Ocular AEs were evaluated.

RESULTS:

A total of 752 and 80 patients with AEs secondary to pegcetacoplan and avacincaptad pegol, respectively, were identified. Ocular AEs disproportionately overreported for pegcetacoplan included anterior segment (iris) hemorrhage (ROR 1767, 95% CI 538-5803), iris neovascularization (ROR 1248, 95% CI 502-3099), choroidal neovascularization (ROR 1328, 95% CI 956-1845), intraocular injection complication (ROR 2552, 95% CI 1607-4053), hemorrhagic occlusive retinal vasculitis (ROR 4606, 95% CI 2000-10,611), retinal occlusive vasculitis (ROR 2352, 95% CI 1313-4212), and bacterial endophthalmitis (ROR 1260, 95% CI 613-2589). Ocular AEs disproportionately overreported for avacincaptad pegol included choroidal neovascularization (ROR 1169, 95% CI 426-3205), vitritis (ROR 782, 95% CI 316-1936), dry age-related macular degeneration (ROR 684, 95% CI 316-1936), and cystoid macular edema (ROR 445, 95% CI 140-1412).

CONCLUSIONS:

Current prescribing patterns indicate that a broader spectrum of ocular AEs were reported for pegcetacoplan than avacincaptad pegol. These findings aim to enhance clinicians' understanding of the safety profiles of these agents, enabling informed patient care and heightened vigilance of these novel GA treatments.

01 Jun 2025·Ophthalmology and Therapy

Clinical Outcomes of Treatment of Geographic Atrophy: A Narrative Review

Review

Author: Torp, Thomas Lee ; Vergmann, Anna Stage ; Nissen, Anne Helene Køllund

RATIONALE:

In 2023, the U.S. Food and Drug Administration approved pegcetacoplan (SYFOVRE) as the first therapeutic option for geographic atrophy (GA), a previously untreatable condition associated with age-related macular degeneration. Following this, avacincaptad pegol (Izervay) was also approved for GA treatment, further expanding therapeutic options.

OBJECTIVES:

This article aims to give an overview of the clinical outcomes of GA treatment and to discuss which patient groups may benefit most from these therapies.

METHODS:

A review of the literature was conducted using the databases PubMed, Cochrane Library, and ClinicalTrials.gov. The search yielded six relevant studies.

CONCLUSIONS:

The management of geographic atrophy has advanced with therapies like pegcetacoplan and avacincaptad pegol showing clear benefits in slowing lesion growth. However, safety concerns, such as neovascular complications, persist. Photobiomodulation and dietary supplementation provide alternative options with modest benefits, particularly in the early stages. Larger studies are needed to confirm long-term safety, efficacy, and optimal treatment strategies.

06 May 2025·RETINA-THE JOURNAL OF RETINAL AND VITREOUS DISEASES

Silicone oil microdroplets from syringes with intravitreal anti-vascular endothelial growth factor and complement inhibitor injections

Article

Author: Wei, Libby ; Thompson, John T. ; Fan, Xiaoxuan ; Lee, Erica

Purpose::

To quantify the amount of silicone oil in intravitreal anti-vascular endothelial growth factor and complement inhibitor injections in prefilled and commercial syringes (silicone-lubricated and silicone-free).

Methods::

Patients deemed clinically appropriate to receive one of five intravitreal medications received the recommended dose. Syringes were overfilled such that 0.01-0.04mL remained after injection for analysis. Aflibercept and ranibizumab were available in prefilled syringes. Pegcetacoplan, faricimab, and avacincaptad pegol were prepared with Becton Dickinson polycarbonate (BD) syringes. Faricimab was also prepared in Ocuject VitreJect® (OV) silicone-free syringes. Samples were analyzed using spectral flow cytometry.

Results::

Silicone oil was found in all syringes. The lowest amounts of silicone oil were found in the Mili-Q water in OV syringes (4.02±0.3 particles per microliter) and ranibizumab 0.5 mg prefilled syringes (8.33±3.1). Intermediate levels of silicone oil were detected in aflibercept prefilled syringes (35.5±21.8) and faricimab in OV syringes (74.6±10.1), significantly greater than Mili-Q water in OV syringes and ranibizumab. Significantly higher levels of silicone oil were found with faricimab (324.9±30), pegcetacoplan (378.1±379.6), and avacincaptad pegol (113.5±14) in BD syringes than the low or intermediate groups. The filter needles used to draw up medications from vials likely contributed to the amount of silicone oil detected in the samples.

Conclusions::

Commonly used BD polycarbonate syringes for intravitreal injections caused significantly higher levels of silicone oil to be injected into the eye than prefilled or silicone free syringes. Repeated injections with more viscous intravitreal drugs increase the amount of silicone oil in the vitreous, leading to symptomatic floaters.

135

News (Medical) associated with Avacincaptad pegol

01 May 2025

·www.prnewswire.com

Astellas to Present New Data in Geographic Atrophy at Upcoming Ophthalmology Annual Congresses

ARVO and RWC abstracts feature analyses on biomarkers, mechanism of disease, patient experience and other data from IZERVAY™ (avacincaptad pegol intravitreal solution) pivotal studies TOKYO, May 1, 2025 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas"), maker of IZERVAY™ (avacincaptad pegol intravitreal solution), a C5 inhibitor for the treatment of geographic atrophy (GA)*, will highlight new data that enhances continued understanding of the science of GA, and the experience of patients living with the progressive disease at the Association for Research in Vision and Ophthalmology Annual Meeting (ARVO), May 4-8, Salt Lake City, Utah, and Retina World Congress (RWC), May 8-11, Fort Lauderdale, Florida. The data comprises nine abstracts, including two oral presentations, featuring analyses on biomarkers, patient experience, mechanism of disease and other insights from the GATHER Phase 3 studies of IZERVAY for the treatment of GA secondary to age-related macular degeneration (AMD). Marci English, Senior Vice President, Biopharma and Ophthalmology Development, Astellas Pharma "Recognizing the early indicators and disease pathways of geographic atrophy are critical to helping patients preserve their existing vision for longer. We look forward to engaging with the retina community at ARVO and RWC to discuss the latest scientific insights in early diagnosis and effective management of GA." Research highlights include: An oral presentation on the structure-function relationship between baseline central subfield ellipsoid zone (EZ) integrity and visual acuity at baseline and future vision loss An oral presentation on baseline EZ integrity features linked to GA progression in eyes with differential shifts in GA growth rate Multiple posters evaluating imaging data from the GATHER1 and GATHER2 studies, which link structure and function in GA Two preclinical posters with structural insights refining the mechanism of action, as well as pharmacokinetics and pharmacodynamics, of avacincaptad pegol (ACP) Data from qualitative studies assessing the experience of patients with GA in the U.S., Spain, Germany and France, including the impact of disease symptoms on health-related quality of life (HRQoL) and coping mechanisms used to manage symptoms of GA Astellas Presentations at 2025 ARVO Annual Meeting Astellas Presentations at RWC 2025 Meeting *avacincaptad pegol intravitreal solution (ACP) is approved for use as IZERVAY™ only in the U.S. About IZERVAY ™ (avacincaptad pegol intravitreal solution) INDICATION AND IMPORTANT SAFETY INFORMATION What is IZERVAY™? IZERVAY (avacincaptad pegol intravitreal solution) is a prescription eye injection, used to treat geographic atrophy (GA), the advanced form of dry age-related macular degeneration (AMD). What is the most important information I should know about IZERVAY? Do NOT receive IZERVAY if you: Have an infection in or around your eye Have active swelling in or around your eye that may include pain and redness IZERVAY can cause serious side effects: Eye injections like the one for IZERVAY can cause an eye infection (endophthalmitis) or separation of layers of the retina (retinal detachment). Call your healthcare provider right away if you have redness of the eye, eye pain, increased discomfort, worsening eye redness, blurred or decreased vision, an increased number of small specks floating in your vision, flashes of light, or increased sensitivity to light. There is a risk of developing wet AMD with IZERVAY. You should report any symptoms (visual distortions such as straight lines seeming bent, deterioration in vision, dark spots, loss of central vision) to your healthcare provider to monitor. IZERVAY may cause a temporary increase in eye pressure after the injection. Your healthcare provider will monitor this after each injection. Before receiving IZERVAY tell your healthcare provider about all of your medical conditions including if you: Have a history of seeing flashes of light or small specks floating in your vision and if you have a sudden increase of size and number of these specks. Have high pressure in the eye or if you have glaucoma. Are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine. Are taking any medications, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Tell your healthcare provider about any medicine you take. What should I avoid while receiving IZERVAY? Your vision may be impaired after receiving an eye injection or after an eye exam. Do not drive or use machinery until your vision has recovered sufficiently. What are the most common side effects of IZERVAY? Blood in the white of the eye Increase in eye pressure Blurred vision Wet age-related macular degeneration These are not all the possible side effects of IZERVAY. Tell your healthcare provider about any side effect that bothers you or that does not go away. Call your healthcare provider for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit , or call 1-800-FDA-1088. Please see full Prescribing Information for more information. About Geographic Atrophy Age-related macular degeneration (AMD) is the major cause of moderate and severe loss of central vision in aging adults, affecting both eyes in the majority of patients. The macula is a small area in the central portion of the retina responsible for central vision. As AMD progresses, the loss of retinal cells and the underlying blood vessels in the macula results in marked thinning and/or atrophy of retinal tissue. Geographic atrophy, associated with AMD, leads to further irreversible loss of vision in these patients. About the GATHER Clinical Trials IZERVAY met its primary endpoint in the GATHER1 (NCT02686658) clinical trial and the GATHER2 (NCT04435366) clinical trial, both of which were randomized, double-masked, sham-controlled, multicenter Phase 3 clinical trials. These trials evaluated the safety and efficacy of monthly 2 mg intravitreal administration of IZERVAY in patients with GA secondary to AMD. For the first 12 months in both trials, patients were randomized to receive either IZERVAY 2 mg or sham monthly. There were 286 participants enrolled in GATHER1 and 448 participants enrolled in GATHER2. The primary efficacy endpoints in both pivotal studies were based on GA area measured by fundus autofluorescence at three time points: baseline, month 6, and month 12. Safety was evaluated in over 700 patients with GA across the two trials. In year 2 of the GATHER2 study, patients treated with IZERVAY in year 1 were re-randomized to receive either IZERVAY dosed monthly (EM, n=96) or every other month (EOM, n=93); patients who received sham in year 1 continued to receive sham in year 2 (n=203). IZERVAY is continuing to be evaluated in an open-label extension study. About Astellas Astellas is a global life sciences company committed to turning innovative science into VALUE for patients. We provide transformative therapies in disease areas that include oncology, ophthalmology, urology, immunology and women's health. Through our research and development programs, we are pioneering new healthcare solutions for diseases with high unmet medical need. Learn more at . Cautionary Notes In this press release, statements made with respect to current plans, estimates, strategies and beliefs and other statements that are not historical facts are forward-looking statements about the future performance of Astellas. These statements are based on management's current assumptions and beliefs in light of the information currently available to it and involve known and unknown risks and uncertainties. A number of factors could cause actual results to differ materially from those discussed in the forward-looking statements. Such factors include, but are not limited to: (i) changes in general economic conditions and in laws and regulations, relating to pharmaceutical markets, (ii) currency exchange rate fluctuations, (iii) delays in new product launches, (iv) the inability of Astellas to market existing and new products effectively, (v) the inability of Astellas to continue to effectively research and develop products accepted by customers in highly competitive markets, and (vi) infringements of Astellas' intellectual property rights by third parties. Information about pharmaceutical products (including products currently in development) which is included in this press release is not intended to constitute an advertisement or medical advice. Contacts for inquiries or additional information: Beth Stevenson, US Therapeutic Area Communications +1-910-200-4272 [email protected] Astellas Pharma Inc. Corporate Communications +81-3-3244-3201 SOURCE Astellas Pharma Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 3Clinical ResultDrug Approval

09 Apr 2025

·www.businesswire.com

Aviceda Therapeutics Appoints Ophthalmology Innovator and Industry Leader Dr. Emmett T. Cunningham, Jr. to Board of Directors

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Aviceda Therapeutics (“Aviceda”), a private, clinical-stage biotech company focused on developing next-generation immunomodulators incorporating its proprietary High Affinity Ligands of Siglecs (HALOS™) nanotechnology platform with an aim to alleviate chronic, non-resolving inflammation, today announced the appointment of Emmett T. Cunningham Jr., M.D., Ph.D., M.P.H. to its Board of Directors. Dr. Cunningham brings more than two decades of experience as a physician-scientist, healthcare entrepreneur, and investor. He was previously a Senior Managing Director at the Blackstone Group following its acquisition of Clarus Ventures, where he was a Managing Director. Throughout his investment career, Dr. Cunningham has led or co-led financings that contributed to the FDA approval of ten therapeutics, including ophthalmic treatments such as Xiidra®, Rhopressa®, Rocklatan®, Syfovre®, and Izervay®. He previously served as Senior Vice President of Medical Strategy at Eyetech Pharmaceuticals, where he played a leadership role in the development of Macugen® (pegaptanib sodium), the first VEGF-A inhibitor approved for neovascular age-related macular degeneration and diabetic macular edema. Prior to Eyetech, Dr. Cunningham held clinical development and licensing roles at Pfizer, focused on central nervous system and ophthalmology assets. “Emmett’s extensive background in science, medicine, and strategic investing, particularly within ophthalmology, adds significant depth to our Board at a time of meaningful momentum for Aviceda,” said Jeffrey Nau, Ph.D., M.M.S., President and Chief Executive Officer of Aviceda Therapeutics. “His unique combination of clinical insight, biopharma operating experience, and investment leadership will be instrumental as we advance AVD-104 into pivotal trials for geographic atrophy and continue to build a leading immunology platform.” “Aviceda is advancing a scientifically compelling approach to immunomodulation that directly addresses longstanding challenges in ophthalmology,” said Dr. Cunningham. “The potential of the HALOS™ platform, beginning with AVD-104, extends beyond current treatment paradigms. I look forward to contributing to the company’s efforts to translate their innovative approaches into meaningful outcomes for patients with serious, underserved diseases.” Dr. Cunningham currently serves on the Boards of Eyconis, Oryon Cell Therapies, Nacuity Pharmaceuticals, and InflammX Therapeutics, and has held board positions at more than a dozen innovative biopharma companies, including Annexon Biosciences (NASDAQ: ANNX), GrayBug Vision (NASDAQ: GRAY), Lumos Pharma (NASDAQ: LUMO), SARcode Biosciences (acquired by Shire), Galera Therapeutics (GRTX) and the SFJ Pharmaceutical Group. He is also the founder and former chairman of the Ophthalmology Innovation Summit (OIS), a long-standing platform that brings together leaders in ophthalmic science, innovation, and investment. Dr. Cunningham is an internationally recognized expert in ocular inflammatory and infectious disease, with more than 400 co-authored publications. He earned an M.D. and M.P.H. in epidemiology and statistics from Johns Hopkins University, and a Ph.D. in neuroscience from the University of California at San Diego for research conducted at The Salk Institute. He completed his ophthalmology residency and fellowship training at UCSF and The Francis I. Proctor Foundation, with additional fellowships in Retina at Moorfields Eye Hospital in London and Public health Ophthalmology at The Dana Center of the Wilmer Eye Institute in Baltimore. He currently teaches at California Pacific Medical Center, serves as an Adjunct Clinical Professor of Ophthalmology at Stanford University, and is a Research Associate at UCSF School of Medicine. About Aviceda Therapeutics and AVD-104 Aviceda is a private, clinical-stage biotechnology company located in Cambridge, MA, with a proprietary High Affinity Ligands of Siglecs (HALOS™) nanotechnology platform and a clinical-stage ophthalmic candidate, AVD-104, for the treatment of geographic atrophy secondary to age-related macular degeneration. AVD-104 is an intravitreal glycan-coated nanoparticle with a dual mechanism of action that modulates critical inflammatory cellular and complement pathways through 1) direct deactivation of inflammatory microglia/macrophages’ phagocytic activity and repolarization of these activated microglia/macrophages to their healing state and 2) inhibition of complement cascade amplification. Along with AVD-104, Aviceda has a broad pipeline of products in development in ophthalmology and multiple other therapeutic areas, including immunology, fibrosis, oncology, and neurology. Visit the company website to learn more about Aviceda Therapeutics and follow the company on LinkedIn and X (formerly Twitter).

Executive ChangeDrug Approval

25 Mar 2025

·endpts.com

Ophthalmology startup Character Biosciences gets $93M for genetics-based approach

Seven years into its existence, Character Biosciences is ready to enter the clinic with a pair of experimental medicines targeting a bustling area of ophthalmology. The New Jersey biotech aims to treat age-related macular degeneration, a key driver of blindness in older adults, based on insights from genetic and imaging data that it collected from more than 6,500 people in an observational study. To get its first candidates into Phase 1 this year, Character announced Tuesday that it raised a $93 million Series B. The biotech previously raised $28 million in funding, including an $18 million Series A in 2022. The financing should take the 30-employee startup through Phase 2 testing for both intravitreal drug candidates, CEO and co-founder Cheng Zhang told Endpoints News . Investors are aMoon, Luma Group, Bausch + Lomb, Jefferson Life Sciences (an affiliate of Jefferson River Capital), Innovation Endeavors, Catalio Capital Management, S32 and KdT Ventures. Character is the second private biotech to announce a funding round on Tuesday after Hillstar Bio revealed its $67 million debut . It’s rare right now to see more than one venture funding round announcement per day, according to a Stifel report on Sunday. The average number of biotech venture rounds per month has slid 10% from two years ago and cratered 40% from the vibrant market of four years ago, according to the Stifel bankers. Character chose its drug targets based on the patient data from the observational study, and the startup believes that wealth of data can also give it a better shot at clinical success because it can hone in on the patients most likely to respond to treatment. Plus, the company worked with more than 150 ophthalmology centers for the observational study, and it plans to use some of those sites for upcoming clinical trials. “It’s been a long journey. It’s taken seven years, in fact, but we didn’t want to make any shortcuts,” Zhang said. “We wanted to build a rigorous company that is rooted in the fundamental science of patient data.” The company is exploring CTX114 as a treatment to slow the progression of geographic atrophy in advanced dry AMD, an increasingly popular category for drugmakers. Astellas and Apellis Pharmaceuticals both received FDA approval for geographic atrophy therapies in 2023 but have since faced regulatory setbacks. Last year, Astellas withdrew its application in Europe, and Apellis’ treatment was rebuffed by the bloc’s regulators, who raised questions about clinical benefit and safety. Like Astellas’ Izervay and Apellis’ Syfovre, Character is also pursuing the complement pathway with CTX114 but is tackling a “different genetically supported” part, according to Zhang. CTX114 is an engineered version of FHL-1, or factor H-like protein 1, a negative regulator of complement activation. Izervay is a complement 5 inhibitor and Syfovre is a C3 inhibitor. The company hopes CTX114 can also offer a less-frequent dosing schedule than Izervay and Syfovre, which are dosed monthy and every 25 to 60 days, respectively. As part of its due diligence on Character, aMoon investors talked with practicing ophthalmologists about the GA landscape, including Izervay and Syfovre. “They said, ‘Look, the risk-benefit for both of these drugs is just not amazing,'” aMoon partner Reut Shema said in an interview. “They said, ‘But we have nothing else. So if you give me something that’s similar efficacy, but just a little bit safer, it’s a multibillion-dollar drug.'” Meanwhile, with CTX203, Character hopes to thwart a patient’s progression to advanced AMD. CTX203 is an apolipoprotein A1 mimetic peptide that aims to stabilize ABCA1 expression. Character is also working with Bausch + Lomb to create new medicines for AMD. The duo began collaborating early last year and announced that work in January. Financial terms have’t been disclosed. “We would love, at a certain time, to move from incidence-driven drug development into a population-specific drug development,” Bausch + Lomb chief medical officer Yehia Hashad said in an interview. Character wants its platform to decipher which patients will be responders from the outset — before even going into clinical studies. “The more we are able to predict patients and treat them prior to getting to the late-stage part of the disease, the better,” Hashad said. The Bausch + Lomb tie-up does not involve Character’s CTX114 or CTX203. “Those could be highly competitive assets,” aMoon’s Shema said, “and because there’s so much interest from pharma companies, we wanted to make sure that this was open territory for different pharmas to bid for those because we think both of them have potential to be multibillion-dollar drugs.” Shema pointed out that Character also has datasets in glaucoma, which could form the basis for additional partnerships.

Drug Approval

100 Deals associated with Avacincaptad pegol

External Link

KEGG	Wiki	ATC	Drug Bank
D11748	-	-	DB15165

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Geographic Atrophy	United States	Astellas Pharma US, Inc.	04 Aug 2023

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Age Related Macular Degeneration	NDA/BLA	Canada	Astellas Pharma Canada, Inc.	01 Feb 2025
Blindness	Phase 3	-	Astellas Pharma, Inc.	19 May 2025
dry age-related macular degeneration	Phase 3	United States	IVERIC bio, Inc.	22 Jun 2020
dry age-related macular degeneration	Phase 3	Argentina	IVERIC bio, Inc.	22 Jun 2020
dry age-related macular degeneration	Phase 3	Australia	IVERIC bio, Inc.	22 Jun 2020
dry age-related macular degeneration	Phase 3	Austria	IVERIC bio, Inc.	22 Jun 2020
dry age-related macular degeneration	Phase 3	Belgium	IVERIC bio, Inc.	22 Jun 2020
dry age-related macular degeneration	Phase 3	Brazil	IVERIC bio, Inc.	22 Jun 2020
dry age-related macular degeneration	Phase 3	Canada	IVERIC bio, Inc.	22 Jun 2020
dry age-related macular degeneration	Phase 3	Colombia	IVERIC bio, Inc.	22 Jun 2020

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02686658 \| NCT04435366 (GATHER2, EURETINA2024) Manual	Phase 2/3	Geographic Atrophy	-	Avacincaptad Pegol 2 mg	tisqhwjqtb(qedjrmslse) = clhyqrdohd goxpgqbtif (ibarqwwgbr )	Positive	19 Sep 2024
NCT04435366 (GATHER2, PRNewswire) Manual	Phase 3	Age Related Macular Degeneration	-	IZERVAY	pkrkizkzge(livvmwwbeg) = IZERVAY was well tolerated over 2 years, with one case each of non-serious intraocular inflammation (IOI) and culture-positive endophthalmitis. There were no cases of ischemic neuropathy or retinal vasculitis. wfvsdkkbfd (pvcsbwcsnc ) View more	Positive	04 Nov 2023
				IZERVAY
EURETINA2023	Not Applicable	Geographic Atrophy	-	Avacincaptad pegol 2 mg	vxmaqumyic(ftvseycvyv) = kmbqmgrnnx mvrfvfvzdf (speqkqvhid, 0.56 - 0.15-2.06)	-	05 Oct 2023
EURETINA2023	Not Applicable	-	-	Avacincaptad pegol 2 mg	gxbcnuedht(hifdpywsyx) = ujqcbbhzhf lzzryophyl (hypvmeliac ) View more	-	05 Oct 2023
NCT02686658 \| NCT04435366 (GATHER2, FDA) Manual	Phase 2/3	Geographic Atrophy	624	IZERVAY (GATHER1)	oqbtbkecpa(dlpcraloqd) = eifgejxehu lgdpntnszy (twsktimkpb )	Positive	04 Aug 2023
				Sham (GATHER1)	oqbtbkecpa(dlpcraloqd) = dsebxexiot lgdpntnszy (twsktimkpb )
NCT04435366 (GATHER2, Corporate Publications) Manual	Phase 3	Geographic Atrophy	447	Avacincaptad pegol	haiilgwowb(awtokmntiq) = jqgunpcnph sougtpnyfh (zyaxqbheqq ) View more	Positive	06 Sep 2022
				Sham	haiilgwowb(awtokmntiq) = hhwfvsuhse sougtpnyfh (zyaxqbheqq ) View more
NCT02686658 (GATHER1, ARVO2022)	Phase 2/3	Geographic Atrophy	-	Avacincaptad pegol 2 mg	amqggsjiuy(gsbzgqgnqb) = plocpetnyn vlhfnihgoc (mzduoqtpgl )	-	01 May 2022
				avacincaptad pegol (Sham)	amqggsjiuy(gsbzgqgnqb) = wfbvnrnteo vlhfnihgoc (mzduoqtpgl )
NCT03362190 (CTgov)	Phase 2	Wet age-related macular degeneration	64	Avacincaptad Pegol+Lucentis (Cohort 1)	scqwbxeyrq = bxjjzqemtg zsltyvuqni (dcpeyxzaqh, lnnwaxmrkz - otcoiochtl) View more	-	02 Feb 2022
				Avacincaptad Pegol+Lucentis (Cohort 2)	scqwbxeyrq = acesrwsvmj zsltyvuqni (dcpeyxzaqh, imsgxlaewz - qstbgkpcsw) View more
NCT02686658 (GATHER1, AAO2021)	Phase 2/3	dry age-related macular degeneration \| Geographic Atrophy	286	Avacincaptad Pegol 2mg	mtjfizmehj(twcssdcupp) = slksecbtty zhccmpglmr (dhfwltcobg )	-	13 Nov 2021
				Avacincaptad Pegol 4mg	mtjfizmehj(twcssdcupp) = ihzjoqysyk zhccmpglmr (dhfwltcobg )

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

AI Agents Built for Biopharma Breakthroughs

Accelerate discovery. Empower decisions. Transform outcomes.

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis