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 Date16 Jul 2025

Sponsor / Collaborator

Roche Holding AG

NCT06970665

/ 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 Date08 Jul 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 Sep 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 0.01-0.04 mL 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.

Conclusion::

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.

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.

145

News (Medical) associated with Avacincaptad pegol

19 Sep 2025

·www.astellas.com

Astellas Receives Conditional Approval for IZERVAY, making it the first and only approved treatment for the Suppression of Geographic Atrophy Growth in Japan

TOKYO, Sep 19, 2025 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced that the Japanese Ministry of Health, Labor and Welfare (MHLW) has granted Conditional Approval of IZERVAY (avacincaptad pegol intravitreal solution: ACP) for the suppression of geographic atrophy (GA) growth in atrophic age-related macular degeneration (AMD). This approval – achieved in just seven months through an expedited pathway designed to bring innovative treatments to patients with serious unmet need – makes ACP the first and only approved treatment for patients living with GA in Japan. In the global GATHER1 and GATHER2 clinical trials, ACP met its primary endpoint by significantly reducing the rate of GA lesion growth compared with sham.1,2 The mean rate of GA lesion growth reduction over 12 months was 35% in GATHER1 and 18% in GATHER2.3 Sustained efficacy was observed over two years of follow-up, with efficacy observed as early as six months following the first injection.1,2,4 ACP was consistently well tolerated across both the trials, with less than 2% of participants stopping treatment due to adverse events.1,2 Marci English, Senior Vice President, Biopharma and Ophthalmology Development, Astellas“This approval highlights the strength of the GATHER clinical program and the value of continued innovation in ophthalmology. Under the Conditional Approval system, we will build on these findings with confirmatory studies to further strengthen the evidence base and expand understanding of how to best help people living with geographic atrophy.” GA is an advanced and irreversible form of age-related macular degeneration that causes progressive vision loss.5 In Japan, GA is estimated to affect nearly 100,000 people.6,7 Without timely treatment, an estimated 66% of people with GA become legally blind or severely visually impaired – a devastating reality that destroys independence and wellbeing.8,9 ACP, a complement C5 inhibitor, significantly slowed the growth of GA lesions, which is expected to slow visual impairment by reducing activation of the complement system, which drives retinal cell degeneration.3,10 Astellas will now work with the relevant authorities to enable patient access to ACP as quickly as possible. The Company has already reflected the impact of this approval in its financial forecast of the current fiscal year ending March 31, 2026. About avacincaptad pegol (ACP)ACP is a synthetic aptamer that inhibits the complement C5 protein.10 Overactivity of the complement system and the C5 protein play a critical role in the development and growth of scarring and vision loss associated with GA secondary to AMD.10 By targeting C5, ACP is considered to decrease activity of the complement system known to cause the degeneration of retinal cells and thus slow the progression of GA.10 About Geographic Atrophy (GA)GA is an advanced form of age-related macular degeneration (AMD) that leads to irreversible and progressive vision loss.8,10,11 It affects the macula, the central portion of the retina responsible for central vision. AMD is the leading cause of visual loss in people aged over 50 years old in developed countries.2 In Japan, an estimated 100,000 people live with GA, and no approved treatments have been available until now.6,7 About the GATHER Clinical Trial ProgramIZERVAY 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. About AstellasAstellas 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 www.astellas.com. Cautionary NotesIn 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. References Click below for a copy of the full press release

Clinical ResultPhase 3Drug Approval

30 Jul 2025

·www.astellas.com

Posted Financial Results for Q1 YTD/FY2025

Jul 30, 2025IR Posted Financial Results for Q1 YTD/FY2025 Jul 17, 2025Press Releases Astellas Announces a Partnership with the “Korea Institute of Startup and Entrepreneurship Development”, an Umbrella Organization of a Korean Government Agency, for the Operation of the“Partnership with Global Companies Program” Jul 10, 2025Press Releases Sales of IZERVAY™ (Preliminary Figures)

Financial Statement

18 Jul 2025

·www.fiercepharma.com

Fierce Pharma Asia—China biotech deal boom; Takeda's narcolepsy win; Sino Biopharm's LaNova buyout

Rising biotech deals involving Chinese drugs, Takeda's positive OX2R readouts, and LaNova's acquisition by Sino Biopharm made our news this week. Biotech deals involving assets developed in China are surging, a Jefferies report shows. Takeda is preparing its narcolepsy candidate oveporexton for an FDA filing after two positive phase 3 readouts. Merck & Co.'s PD-1xVEGF partner is being acquired. And more.1. China biotechs ‘reshaping’ US biopharma as outlicensing deals rise 11%: Jefferies reportAbout a third of biopharma’s outlicensing deal value in the first quarter of 2025 centered on Chinese assets, versus 21% during the same period in both 2024 and 2023, according to Jefferies. Since 2022, China biotechs have developed 639 first-in-class drug candidates, a sharp rise compared with prior years, Jefferies tallied.2. Takeda’s narcolepsy blockbuster hopeful secures double phase 3 wins, teeing up FDA filingTakeda’s OX2R agonist oveporexton has hit the mark in two phase 3 narcolepsy trials. The FirstLight and RadiantLight trials met their primary endpoints showing statistically significant improvements for the drug compared with placebo in excessive daytime sleepiness, as measured by the Maintenance of Wakefulness Test at week 12. The company is now preparing for an FDA approval filing.3. Sino Biopharm buys Merck's PD-1xVEGF bispecific partner LaNova for up to $951MLaNova Medicines, from which Merck & Co. recently licensed a PD-1xVEGF bispecific candidate, is being bought out by Chinese compatriot Sino Biopharmaceutical in a deal worth up to $951 million. In addition, LaNova also provided AstraZeneca with a GPRC5D-targeting antibody-drug conjugate. Before the LaNova transaction, very few, if any, Chinese pharmas have acquired innovative domestic biotechs.4. For Lundbeck and Otsuka's PTSD filing, FDA questions Rexulti efficacy after failed phase 3For an upcoming advisory committee meeting, the FDA flagged “discordant results” from two phase 3 trials that Lundbeck and Otsuka are using in their application for Rexulti, in combination with Viatris’ Zoloft, as a treatment for post-traumatic stress disorder. The FDA is asking experts to weigh in on whether an exploratory phase 2 study can overcome one negative phase 3.5. Otsuka inks $613M deal for Swedish biotech's autoimmune antibodiesOtsuka is paying $33 million upfront for Cantargia’s IL1RAP antibody, CAN10, as well as a backup candidate, against autoimmune and inflammatory disorders. The deal also includes up to $580 million in milestone payments and gives the Japanese drugmaker exclusive first rights of negotiation for Cantargia’s next-gen IL1RAP programs.6. Sun Pharma's alopecia med Leqselvi hits US market after Incyte patent settlementSun Pharma has reached a patent settlement with Incyte so the Indian company can launch its JAK inhibitor Leqselvi in the U.S. for severe alopecia areata. Sun will pay an undisclosed upfront payment plus royalty payments until the related patents expire. The deal ended a lawsuit in which Incyte claimed that Leqselvi would infringe on patents around its blockbuster ruxolitinib.7. FDA hands down citations to 3 drugmakers after inspections found contamination, testing concernsMeanwhile, a Sun Pharma plan in Gujarat, India was subject to a 19-page, eight-observation Form 483 following an FDA inspection in June. Some citations, such as “poor aseptic behavior and inadequate environmental monitoring,” had previously been flagged in an FDA warning letter in 2022. Separately, a Daewoo Pharm site in Busan, Korea, and a Glenmark facility in Madhya Pradesh, India, received FDA warning letters.Other News of Note:8. Astellas reports 22% sales bump for Izervay, expects trend to continue this year9. China sentences Astellas exec to 3.5 years in prison for espionage (Bloomberg)10. Hengrui's GLP-1/GIP agonist reports 18% weight loss in phase 3 trial, readies China push11. Acumen taps JCR’s blood-brain barrier tech for $555M Alzheimer’s deal12. GSK expands Medicines Patent Pool deal to allow generic production of cabotegravir for HIV treatment13. Kowa licenses Nicox’s intraocular pressure eye drop for up to €191.5M (release)14. Korea’s Illimis raises $42M series B to advance Alzheimer’s candidate (release)

Phase 3Acquisition

100 Deals associated with Avacincaptad pegol

External Link

KEGG	Wiki	ATC	Drug Bank
D11748	-	-	DB15165

R&D Status

Approved

10 top approved records.

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

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Age Related Macular Degeneration	NDA/BLA	Canada	Astellas Pharma Canada, Inc.	01 Feb 2025
Blindness	Phase 3	Japan	Astellas Pharma, Inc.	08 Jul 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

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02686658 \| NCT04435366 (GATHER2, EURETINA2024) Manual	Phase 2/3	Geographic Atrophy	-	Avacincaptad Pegol 2 mg	ehbjfvrnzb(apobbewwvk) = uuyilbqtxk joffsutqqm (fjzcauzize )	Positive	19 Sep 2024
NCT04435366 (GATHER2, PRNewswire) Manual	Phase 3	Age Related Macular Degeneration	-	IZERVAY	unblnbdyst(itvgxabdfl) = 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. mbgmswshqg (qwhewbmkib ) View more	Positive	04 Nov 2023
				IZERVAY
EURETINA2023	Not Applicable	Geographic Atrophy	-	Avacincaptad pegol 2 mg	bkjkujkmxe(hfmcfqvjjn) = ookinyvhkx laugrqrrlk (iaswspmyxj, 0.56 - 0.15-2.06)	-	05 Oct 2023
EURETINA2023	Not Applicable	-	-	Avacincaptad pegol 2 mg	aaiunyvjey(iwfbrktcav) = jqiqkkpdxr fiidhqhadi (ytmktznozh ) View more	-	05 Oct 2023
NCT02686658 \| NCT04435366 (GATHER2, FDA) Manual	Phase 2/3	Geographic Atrophy	624	IZERVAY (GATHER1)	gaqjmmwbzl(hsevdydiqk) = tzmkhrbtjh aahdudggkw (rmctccdfkp )	Positive	04 Aug 2023
				Sham (GATHER1)	gaqjmmwbzl(hsevdydiqk) = yqdanxxczi aahdudggkw (rmctccdfkp )
NCT04435366 (GATHER2, Corporate Publications) Manual	Phase 3	Geographic Atrophy	447	Avacincaptad pegol	vtmmhqsmbe(bnxvxlenya) = lpkkxlukmq zdaqnmsjne (nudscsutry ) View more	Positive	06 Sep 2022
				Sham	vtmmhqsmbe(bnxvxlenya) = nbcoyxnouh zdaqnmsjne (nudscsutry ) View more
NCT02686658 (GATHER1, ARVO2022)	Phase 2/3	Geographic Atrophy	-	Avacincaptad pegol 2 mg	vuakpgufwe(pqfknjtbro) = qlbraakxio rmpbywyort (wyqxgufslz )	-	01 May 2022
				avacincaptad pegol (Sham)	vuakpgufwe(pqfknjtbro) = ghredlinro rmpbywyort (wyqxgufslz )
NCT03362190 (CTgov)	Phase 2	Wet age-related macular degeneration	64	Avacincaptad Pegol+Lucentis (Cohort 1)	quoeeelefj = rprdozpqeb qodrtbxnvm (fhnyejooiy, imrwztuzsb - tbqyelmghp) View more	-	02 Feb 2022
				Avacincaptad Pegol+Lucentis (Cohort 2)	quoeeelefj = daqwuabjcc qodrtbxnvm (fhnyejooiy, cdpaodoaoh - ljydmgmtdn) View more
NCT02686658 (GATHER1, AAO2021)	Phase 2/3	dry age-related macular degeneration \| Geographic Atrophy	286	Avacincaptad Pegol 2mg	sniaqxnank(gasbxljmwl) = pvblrmploc nulbdfsxxa (ffgevdnyxb )	-	13 Nov 2021
				Avacincaptad Pegol 4mg	sniaqxnank(gasbxljmwl) = gsusizsdol nulbdfsxxa (ffgevdnyxb )

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