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.

NCT05536297

/ Active, not recruitingPhase 3

An Open-label Extension (OLE) Phase 3 Trial to Assess the Safety of Intravitreal Administration of Avacincaptad Pegol (Complement C5 Inhibitor) in Patients With Geographic Atrophy Who Previously Completed Phase 3 Study ISEE2008 (GATHER2)

The purpose of this study is to assess long-term safety of avacincaptad pegol intravitreal administration for patients with geographic atrophy (GA) who completed Study ISEE2008 (GATHER2) through the Month 24 visit on study treatment (either avacincaptad pegol or Sham).

Start Date26 Sep 2022

Sponsor / Collaborator

Astellas Pharma Global Development, Inc.

NCT04435366

/ CompletedPhase 3

A Phase 3 Multicenter, Randomized, Double Masked, Sham- Controlled Clinical Trial to Assess the Safety and Efficacy of Intravitreal Administration of Zimura (Complement C5 Inhibitor) in Patients With Geographic Atrophy Secondary to Age-Related Macular Degeneration

The objectives of this study was to evaluate the safety and efficacy of avacincaptad pegol intravitreal administration in participants with geographic atrophy secondary to age-related macular degeneration (AMD)

Start Date22 Jun 2020

Sponsor / Collaborator

IVERIC bio, 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 Mar 2025·Graefe's Archive for Clinical and Experimental Ophthalmology

Progression to complete retinal pigment epithelium and outer retinal atrophy (cRORA): post hoc analysis of the GATHER1 trial

Article

Author: Desai, Dhaval ; Corradetti, Giulia ; Abulon, Dina ; Sadda, SriniVas R. ; Sadda, SriniVas R ; Velaga, Swetha B ; Attiku, Yamini ; Srinivas, Sowmya ; Nittala, Muneeswar Gupta ; Corvi, Federico ; Lindenberg, Sophiana ; Karamat, Ayesha ; Velaga, Swetha B. ; Zhu, Liansheng

Abstract:

Purpose:

Determine rates of progression of incomplete retinal pigment epithelium and outer retinal atrophy (iRORA) to complete retinal pigment epithelium and outer retinal atrophy (cRORA) and rates of progression of drusen to iRORA/cRORA in eyes with geographic atrophy (GA) treated with avacincaptad pegol (ACP).

Methods:

Post hoc analysis of the GATHER1 prospective, randomized, double-masked Phase II/III study that evaluated ACP 2 mg vs. sham. Optical coherence tomography (OCT) data from GATHER1 were transferred to the Doheny Image Reading and Research Lab for masked analysis by readers experienced with Classification of Atrophy Meeting (CAM) grading features. Regions of OCT volume scans more than 500 µm from the border of GA lesions were evaluated at baseline and at months 6, 12, and 18. Participants with iRORA and/or drusen (≥ 40 µm height on OCT) at baseline were included in the analysis.

Results:

The proportion of eyes progressing from iRORA to cRORA in the ACP 2 mg group was 5.0%, 15.0%, and 20.0% at months 6, 12, and 18 respectively, as compared with 11.8%, 30.2%, and 41.8% of eyes in the sham group. The proportion of ACP 2 mg-treated eyes progressing from drusen to iRORA or cRORA was 3.8%, 7.6%, and 7.6% at months 6, 12, and 18 compared with 15.9%, 18.1%, and 27.2% of sham-treated eyes.

Conclusions:

Rates of progression from iRORA to cRORA and drusen to iRORA/cRORA were reduced in eyes treated with ACP 2 mg vs. sham, with increasing separation between groups over time, suggesting early intervention may slow disease progression.

Trial registration:

ClinicalTrials.gov identifier: NCT02686658. Date of registration: February 16, 2016.

Key messages:

What is knownGeographic atrophy is an advanced form of age-related macular degeneration (AMD) that leads to irreversible vision loss, presenting a significant public health unmet need.The Classification of Atrophy Meeting (CAM) group recommended a new nomenclature for advanced AMD lesions, based on the affected anatomical layers on optical coherence tomography. Accordingly, the terms incomplete retinal pigment epithelium and outer retinal atrophy (iRORA) and complete retinal pigment epithelium and outer retinal atrophy (cRORA) were introduced (Guymer et al., Ophthalmology 127:394–409, 2020; Sadda et al., Ophthalmology 125:537–548, 2018).What is newGATHER1 post hoc analysis shows that treatment with avacincaptad pegol (ACP) 2 mg decreases the proportion of eyes that progress from iRORA to cRORA, and from drusen to iRORA or cRORA, compared with sham, over 6, 12, and 18 months.These findings suggest a potential role for ACP in delaying the progression of existing pre-atrophic AMD lesions

01 Feb 2025·EYE

Gene therapy for geographic atrophy in age-related macular degeneration: current insights

Review

Author: Waheed, Nadia K ; Waheed, Nadia K. ; Jamil, Muhammad Usman

Geographic atrophy (GA) is the advanced stage of non-neovascular (dry) age-related macular degeneration, defined by the presence of sharply demarcated atrophic lesions of the outer retina. The complement system is integral to the body's natural immune response, and hence its overactivation can lead to tissue damage and inflammation. It has been shown to play a significant role in GA lesion development and progression, and therefore, complement inhibition is emerging as a promising avenue for therapeutic intervention. With the recent approval by the Food and Drug Administration of drugs like SYFOVRE™ (pegcetacoplan injection) and IZERVAY™ (avacincaptad pegol intravitreal solution), there is hope for the development of interventions capable of slowing down or arresting the progression of GA. In particular, gene therapy intervention is gaining traction for halting GA atrophy at the source of our genes. The concept is to insert a gene into the eye that will act as an ocular "bio-factory," producing a desired protein. This can either lead to overproduction of an already available protein or produce a substance not typically generated in the eye. This review aims to provide an overview of the present understanding of GA, encompassing risk factors, prevalence, pathophysiology, and genetic associations. It will also highlight the current landscape of GA treatment, with particular emphasis on gene therapy intervention.

01 Feb 2025·Pharmacology Research & Perspectives

Intravitreal Administration of Avacincaptad Pegol in a Nonhuman Primate Model of Dry Age‐Related Macular Degeneration

Article

Author: Natsume, Takahiro ; Itani, Yoshitaka ; Fujii, Rintaro ; Takamatsu, Hiroyuki ; Matsushita, Mayumi ; Hama, Aldric

ABSTRACT:

The lack of effective treatments for dry age‐related macular degeneration (AMD) is in part due to a lack of a preclinical animal model that recapitulates features of the clinical state including macular retinal pigment epithelium (RPE) degeneration, also known as geographic atrophy (GA). A nonhuman primate model of GA was developed and its responsiveness to an approved treatment, avacincaptad pegol (ACP), a complement C5 inhibitor, was evaluated. Intravitreal (ivt) administration of sodium iodate (SI) into one eye of male Macaca fascicularis leads to retinal areas (mm2) of hyper‐ or hypo‐autofluorescence. Qualitative changes to the retinal structure over time were observed with spectral domain optical coherence tomography (OCT). Six days after SI administration, prior to treatment, mean (± SEM) GA of all eyes was 8.2 ± 1.8 mm2. Following randomization to treatment groups, either vehicle or ACP was ivt injected and treatment was continued every 4 weeks, for a total of four treatments. Sixteen weeks after SI administration, the GA area in vehicle‐treated eyes was 18.9 ± 6.6 mm2, whereas GA in ACP‐treated eyes was 11.4 ± 4.0 mm2, a reduction by about 36%. Increased, followed by decreased, overall macular thickness was observed with OCT over time following SI administration. Treatment with ACP did not change alter macular thickness thinning. Geographic atrophy‐like lesions that expand over time are observed following SI administration. The current macaque model could be utilized to further explore the mechanism of dry AMD and to develop more novel therapeutics.

131

News (Medical) associated with Avacincaptad pegol

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

25 Mar 2025

·www.biopharmadive.com

Character Biosciences raises $93M with an eye on vision loss drugs

Character Biosciences, a biotechnology startup developing treatments for vision loss, said Tuesday it raised $93 million in a Series B round.The financing will help Character bring its two most advanced programs into clinical testing. One, dubbed CTX114, is being tested in geographic atrophy, a common eye condition and an advanced stage of age-related macular degeneration, or AMD. The other, CTX203, is designed to halt progression in people with intermediate AMD, so they dont develop geographic atrophy or other forms of advanced disease. Both drug prospects should begin Phase 1 trials this year.In geographic atrophy, Character aims to challenge two marketed drugs Apellis Pharmaceuticals Syfovre and Astellas Pharmas Izervay. Both can slow the growth of the patchy, map-like eye lesions that create blind spots in people with geographic atrophy. However, testing hasnt clearly shown that doing so preserves vision. And in rare cases, Syfovre has been associated with severe side effects.Like Syfovre and Izervay, CTX114 works on the complement system, an arm of the bodys immune system. According to Character co-founder and CEO Cheng Zhang, CTX114 does so differently, mimicking the function of a protein that stops the complement system from overactivating, but that malfunctions in AMD. Preclinical testing has suggested the approach may be more effective, though that hasnt been proven in humans.Characters second drug is being developed for people who dont yet have advanced AMD and arent typically treated. CTX203 is designed to stabilize expression of a protein called ABCA1 thats involved in lipid transport by retinal cells. Lower ABCA1 levels are associated with an abnormal buildup of lipids that can lead to AMD progression.While there are many medications for wet AMD, drugmakers have had less success with the dry form that accounts for the bulk of the estimated 200 million people worldwide with the disease. Zhang says a big reason why is the diseases heterogeneity and varied progression, which makes it difficult to design clinical trials. Character has collected a trove of AMD patient data to help design its drugs and identify the specific groups of people it intends to enroll in studies.What gives us comfort is that we have mapped out those challenges, we have a deeper understanding of how we might mitigate those risks, Zhang said. We can subtype patients, understand those patients who are more likely to respond to our therapy, and have a drug that has more applications in the first place.Characters Series B round was led by aMoon and Luma Group, and involved Bausch + Lomb, Jefferson Life Sciences and four other investors. Bausch + Lomb also announced a collaboration with the biotech in January.Characters patient-first approach is unique in its ability to identify those who are most likely to benefit from therapy, and we look forward to seeing the clinical impact of this approach with the use of proceeds from this financing, Jamie Kasuboski, a partner and head of research at Luma Group, said in a statement.Character was formerly known as Clover Therapeutics, which was launched in 2019 by the health insurance firm Clover Health. The company previously raised an $28 million in funding, Zhang said. '

07 Mar 2025

·www.prnewswire.com

February Recap: 15 Top Health Press Releases

A roundup of the most newsworthy healthcare press releases from PR Newswire, including business strategies shaping the future of healthcare and three major health news trends. NEW YORK, March 7, 2025 /PRNewswire/ -- With thousands of press releases published each month, it can be difficult to keep up with everything on PR Newswire. To help healthcare journalists and consumers stay on top of the month's most popular releases and newsworthy trends, here's a recap of some of the past month's most read- and engaged-with stories. The list below includes the headline (with a link to the full text) and an excerpt from each story. Click on the press release headlines to access accompanying multimedia assets that are available for download. Continue Reading PR Newswire Monthly Health Press Release Roundup, February 2025. Photos provided by CINDE, Sebela Pharmaceuticals Inc and WeWard. BD Announces Intent to Separate Biosciences and Diagnostic Solutions Business to Enhance Focus, Drive Growth and Unlock Value "Our BD 2025 strategy has transformed the company into a faster-growing, more profitable organization positioned at the forefront of long-term growth trends in health care," said Tom Polen, chairman, CEO and president of BD. FDA Approves MIUDELLA®, the First Hormone-Free Copper Intrauterine System (IUS) in the U.S. in Over 40 Years, from Sebela Women's Health Inc. "This innovative intrauterine device may allow for improvements in discontinuation rates due to pain and bleeding and in expulsion rates. This would be very meaningful for women looking for hormone-free options," said Principal Investigator David K. Turok, MD, MPH, Professor, Department of Obstetrics and Gynecology, University of Utah. Lilly launches additional Zepbound vial doses and offers new savings for self-pay patients Self-pay patients with obesity now have additional Zepbound vial options, including 2.5 mg, 5 mg, 7.5 mg and 10 mg doses. In addition to expanding the doses available, Lilly has reduced prices of the 2.5 mg and 5 mg vials to $349 per month and $499 per month, respectively. Costa Rica Continues to Strengthen Its Position as a Leading Hub for Life Sciences Companies Since 2017, Costa Rica's medical device exports have grown at an average annual rate of 18%, surpassing $8 billion in 2024. This rapid expansion has positioned the country as Latin America's second-largest exporter of medical devices and the fifth-largest supplier of these products to the United States. The Cigna Group Launches Actions to Drive Positive Change for Customers and Patients "The health care system in America needs to be better, and we have challenged ourselves to help lead and drive systemic change," said David M. Cordani, chairman and CEO of The Cigna Group. "We do a lot of good for many people, but we need to do better for everyone. We are committed to implementing tangible actions across our company to help drive better health outcomes and health care experiences." Biohaven Announces FDA Acceptance and Priority Review of Troriluzole New Drug Application for the Treatment of Spinocerebellar Ataxia Troriluzole has a well-established safety profile and if approved, would be the first and only FDA-approved treatment for Spinocerebellar Ataxia (SCA), a rare, genetic, life-threatening neurodegenerative disease. AbbVie and Xilio Therapeutics Announce Collaboration and Option Agreement to Develop Novel Tumor-Activated Immunotherapies The collaboration will combine AbbVie's oncology expertise and Xilio's proprietary tumor-activation technology to develop novel immunotherapies, including masked T-cell engagers. Solventum Announces Sale of its Purification & Filtration Business to Thermo Fisher Scientific Inc. for $4.1B "We are confident that Thermo Fisher will provide the Purification & Filtration business – which offers filters and membranes for use in the manufacturing of biopharmaceutical and medical technologies, microelectronics and food, beverage products and drinking water – the strategic investment and resources needed for sustaining growth and delivering customer solutions," said Bryan Hanson, Solventum CEO. FDA Approves First Rapid-Acting Insulin Biosimilar Product for Treatment of Diabetes As a rapid-acting insulin, Merilog helps to lower mealtime blood sugar spikes to improve control of blood sugar in people with diabetes. The approval is for both a 3 milliliter (mL) single-patient-use prefilled pen and a 10 milliliter (mL) multiple-dose vial. Chan Zuckerberg Initiative Launches Billion Cells Project with 10x Genomics and Ultima Genomics to Advance AI in Biology "Biology not only needs more data – the field needs more data faster and in interoperable formats to support AI models that address specific problems, and this project represents a unique approach to scaling and standardizing scientific outputs for AI and more," said Jonah Cool, Cell Science Senior Science Program Officer at CZI. Medtronic earns U.S. FDA approval for the world's first Adaptive deep brain stimulation system for people with Parkinson's DBS is similar to a cardiac pacemaker, but for the brain. It uses a surgically implanted neurostimulator via a minimally invasive procedure to transmit electrical signals to specific parts of the brain affected by debilitating neurological disorders. Illumina unveils first-of-its-kind spatial transcriptomics technology Illumina has announced a new spatial technology program that will empower researchers to map complex tissues and understand cellular behavior at an unprecedented scale. "With this innovation, we are setting a new bar that will drive the next wave of scientific discoveries and unlock a deeper understanding of biology," said Steve Barnard, PhD, chief technology officer of Illumina. U.S. FDA Approves EMBLAVEO™ (aztreonam and avibactam) for the Treatment of Adults With Complicated Intra-Abdominal Infections With Limited or No Treatment Options "As bacteria evolve, industry, government, and clinical experts must work together to ensure that the infectious disease community has the tools to advance public health," said Roopal Thakkar, M.D., executive vice president, research & development, chief scientific officer, AbbVie. "We're proud to offer this important novel treatment option to urgently address the significant threat of antimicrobial resistance." U.S. FDA Approves Expanded Label for Astellas' IZERVAY™ (avacincaptad pegol intravitreal solution) for Geographic Atrophy Since receiving a permanent J-code in April 2024, IZERVAY has had month-over-month growth in the U.S. with more than 210,000 vials distributed through the end of December 2024. Texas Children's Hospital and UT MD Anderson Announce Joint Venture to End Childhood Cancer The partnership forms the nation's largest complement of pediatric subspecialty care and services to children diagnosed with all types of cancer within a single entity, with operations planned to launch in early 2026. For more news like this, check out all of the latest health-related releases from PR Newswire. Trending Topics Among the health news that was distributed in February, the PR Newswire team was able to spot several larger stories that highlight the trends shaping the industry. American Heart Month: February featured extensive focus on cardiovascular health with diverse awareness initiatives across multiple sectors. Prevention took center stage as Venus Williams invested in the WeWard walking app, Planet Fitness promoted strength training accessibility, and Texas advocates rallied for cardiac emergency response plans in schools during Heart Month. Former Miss Ohio Lindsay Davis joined cardiologists to raise awareness for hypertrophic cardiomyopathy, while NFL Hall of Famer Jerome Bettis partnered with the CDC Foundation's Live to the Beat campaign to address hypertension's impact on Black adults. HIMSS25: The healthcare technology sector generated significant wire activity surrounding the 2025 HIMSS Global Health Conference in Las Vegas (March 3-6). AI innovation dominated announcements, with companies unveiling solutions ranging from Kontaktio's agentic AI for care orchestration to Amtelco's AI-powered virtual agent Ellie. Industry collaboration also emerged as a key theme, with major EHR providers MedAllies, Epic, Netsmart, and eClinicalWorks announcing a joint demo, while Microsoft partnered with Canary Speech to advance digital health transformation. Rare Disease Day: As Rare Disease Day approached on Feb. 28, PR Newswire distributed numerous announcements highlighting advocacy efforts and research breakthroughs. The National Organization for Rare Disorders (NORD) released a critical report on newborn screening programs and later partnered with Paramount Pictures to amplify awareness. The Rare Disease Diversity Coalition prepared to host its 2nd Annual RISE Awards, while NFL legends joined advocates from 49 states for the 14th annual Rare Disease Week on Capitol Hill. Additional mainstream support for the rare disease community came from the New York Stock Exchange with a special pre-market update commemorating Rare Disease Day. Looking ahead: This March, women's health themes will likely dominate coverage surrounding International Women's Day (March 8) and throughout Women's History Month. PR Newswire also anticipates significant activity around National Nutrition Month, with releases spotlighting dietary innovations and wellness campaigns. Do you have a health press release to distribute? Sign up with PR Newswire to share your story with the audiences who matter most. Helping Journalists Stay Up to Date on Industry News These are just a few of the recent press releases that consumers and the media should know about. To be notified of releases relevant to their coverage area, journalists can set up a custom newsfeed with PR Newswire for Journalists. Once they're signed up, reporters, bloggers, and freelancers have access to the following free features: Customization: Users can create customized newsfeeds that will deliver relevant news right to their inbox. Newsfeed results can be targeted by keywords, industry, subject, geography, and more. Photos and Videos: Thousands of multimedia assets are available to download and include in a journalist or blogger's next story. Subject Matter Experts: Journalists will have access to ProfNet, a database of industry experts to connect with as sources or for quotes in their articles. Related Resources: Our journalist- and blogger-focused blog, Beyond Bylines, features regular media news roundups, writing tips, upcoming events, and more. About PR Newswire PR Newswire is the industry's leading press release distribution partner with an unparalleled global reach of more than 440,000 newsrooms, websites, direct feeds, journalists and influencers and is available in more than 170 countries and 40 languages. From our award-winning Content Services offerings, integrated media newsroom and microsite products, Investor Relations suite of services, paid placement and social sharing tools, PR Newswire has a comprehensive catalog of solutions to solve the modern-day challenges PR and communications teams face. For 70 years, PR Newswire has been the preferred destination for brands to share their most important news stories across the world. For questions, contact the team at [email protected]. SOURCE PR Newswire WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Drug ApprovalImmunotherapy

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
dry age-related macular degeneration	Phase 3	United States	IVERIC bio, Inc.	15 Dec 2015
dry age-related macular degeneration	Phase 3	Croatia	IVERIC bio, Inc.	15 Dec 2015
dry age-related macular degeneration	Phase 3	Czechia	IVERIC bio, Inc.	15 Dec 2015
dry age-related macular degeneration	Phase 3	Estonia	IVERIC bio, Inc.	15 Dec 2015
dry age-related macular degeneration	Phase 3	Hungary	IVERIC bio, Inc.	15 Dec 2015
dry age-related macular degeneration	Phase 3	Israel	IVERIC bio, Inc.	15 Dec 2015
dry age-related macular degeneration	Phase 3	Latvia	IVERIC bio, Inc.	15 Dec 2015
Dystrophy, Macular	Phase 3	-	Archemix Corp.	-
Stargardt Disease	Phase 2	United States	Astellas Pharma Global Development, Inc.	12 Jan 2018

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	zxmwwrtqgt(uhztnrovll) = fkifzlolgi foxrepzjap (ayvxvkgdgs )	Positive	19 Sep 2024
NCT04435366 (GATHER2, PRNewswire) Manual	Phase 3	Age Related Macular Degeneration	-	IZERVAY	xkefqwtjhu(ovkrluerdp) = 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. ytcslzabwy (rujsxkmrzd ) View more	Positive	04 Nov 2023
				IZERVAY
EURETINA2023	Not Applicable	Geographic Atrophy	-	Avacincaptad pegol 2 mg	obzzhbgdgj(dnjqsdujya) = hccnwotsaj vadpemjhtm (uhrvzxhfbs, 0.56 - 0.15-2.06)	-	05 Oct 2023
EURETINA2023	Not Applicable	-	-	Avacincaptad pegol 2 mg	vokkhkffxk(qburoidbzv) = zmdforlrpm tqpmuuipzy (siktuymjak ) View more	-	05 Oct 2023
NCT02686658 \| NCT04435366 (GATHER2, FDA) Manual	Phase 2/3	Geographic Atrophy	624	IZERVAY (GATHER1)	bboqxkmjnw(ocuznijkgv) = nsxsgrvysh zmybsmboeh (iqelahosuz )	Positive	04 Aug 2023
				Sham (GATHER1)	bboqxkmjnw(ocuznijkgv) = oxkiyjovyu zmybsmboeh (iqelahosuz )
NCT04435366 (GATHER2, Corporate Publications) Manual	Phase 3	Geographic Atrophy	447	Avacincaptad pegol	ixirhssbfg(stiqfgnxsa) = ffcakrttux yyzmvdeorm (diaslojhbz ) View more	Positive	06 Sep 2022
				Sham	ixirhssbfg(stiqfgnxsa) = dzdajwjdpi yyzmvdeorm (diaslojhbz ) View more
NCT02686658 (GATHER1, ARVO2022)	Phase 2/3	Geographic Atrophy	-	Avacincaptad pegol 2 mg	ogboxuslvk(hjcyubrscu) = idlnbcnnzd sazifpimmo (tlavtklpph )	-	01 May 2022
				avacincaptad pegol (Sham)	ogboxuslvk(hjcyubrscu) = rmvplmnevq sazifpimmo (tlavtklpph )
NCT03362190 (CTgov)	Phase 2	Wet age-related macular degeneration	64	Avacincaptad Pegol+Lucentis (Cohort 1)	hmpskswcwe = gfstxewyom kdkchmyovj (ndizacubry, sdpnbsjlyb - xvjrpagsgz) View more	-	02 Feb 2022
				Avacincaptad Pegol+Lucentis (Cohort 2)	hmpskswcwe = gqgomtxpug kdkchmyovj (ndizacubry, efhjdzqvng - lnjwbzqbav) View more
NCT02686658 (GATHER1, AAO2021)	Phase 2/3	dry age-related macular degeneration \| Geographic Atrophy	286	Avacincaptad Pegol 2mg	ubdzwrilvv(iiwckkdydc) = gkbxdmmhyv lpvxgrognd (eastjlkore )	-	13 Nov 2021
				Avacincaptad Pegol 4mg	ubdzwrilvv(iiwckkdydc) = lqxalfkvvo lpvxgrognd (eastjlkore )

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