Delving into the Latest Updates on Pegpleranib Sodium with Synapse

Overview

Basic Info

Drug Type

Aptamers

Synonyms

Fovista, Pegpleranib, DD50D2QKH1 (UNII code)

+ [7]

Target

PDGF

Mechanism

PDGF inhibitors(Platelet-derived growth factor inhibitors)

Therapeutic Areas

Congenital DisordersEye DiseasesOther Diseases+ [1]

Active Indication-

Inactive Indication

Dystrophy, MacularFibrosisRetinoblastoma+ [2]

Originator Organization

Archemix Corp.

Active Organization-

Inactive Organization

IVERIC bio, Inc.Ophthotech Corp. (New Jersey)

Drug Highest PhaseDiscontinuedPhase 3

First Approval Date-

Regulation-

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Gene Sequence

Sequence Code 239098577

Source: *****

Background: People with Von-Hippel-Lindau (VHL) disease may experience significant vision loss as a result of retinal capillary hemangiomas (RCH), the most common and often earliest manifestation of VHL.
Objective: To investigate the safety and possible efficacy of combination investigational treatment with serial intravitreal injections of E10030, a PDGF-B antagonist, and ranibizumab, a VEGF-A antagonist, in participants with severe ocular VHL disease.
Design: Three participants with severe ocular VHL disease will receive the combination investigational treatment in one eye and will be followed for 104 weeks.
Primary Outcome: The safety of the combination investigational treatment, assessed by tabulation of adverse events reported through Week 52.

Start Date23 Jan 2017

Sponsor / Collaborator

National Eye Institute

NCT02387957 / TerminatedPhase 2

A 24 Month Phase 2a Open Label, Randomized Study of Avastin®, Lucentis®, or Eylea® (Anti-VEGF Therapy) Administered in Combination With Fovista® (Anti-PDGF BB Pegylated Aptamer)

To evaluate the safety of intravitreal (IVT) Fovista® administered in combination with anti-VEGF therapy.

Start Date26 Apr 2016

Sponsor / Collaborator

Ophthotech Corp. (New Jersey)

EUCTR2015-000519-42-IT / Not yet recruitingPhase 2

Role of multimodal imaging in the evaluation of anatomic alterations in neovascular Age-Related Macular Degeneration (AMD) subjects: 18 monthPhase 2a open label study of Fovista¿ (anti-PDGF therapy) administered in combination with anti-VEGF therapy - OPH1008

Start Date15 Dec 2015

Sponsor / Collaborator

IVERIC bio, Inc.

100 Clinical Results associated with Pegpleranib Sodium

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100 Translational Medicine associated with Pegpleranib Sodium

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100 Patents (Medical) associated with Pegpleranib Sodium

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7

Literatures (Medical) associated with Pegpleranib Sodium

01 Jan 2023·International journal of nanomedicine

Discovery of Aptamers and the Acceleration of the Development of Targeting Research in Ophthalmology.

Review

Author: Zhang, Feng ; Cao, Jiamin ; Xiong, Wei

Aptamers are widely applied to diagnosis and therapy because of their targeting. However, the current progress of research into aptamers for the treatment of eye disorders has not been well-documented. The current literature on aptamers was reviewed in this study. Aptamer-related drugs and biochemical sensors have been evaluated for several eye disorders within the past decade; S58 targeting TGF-β receptor II and pegaptanib targeting vascular endothelial growth factor (VEGF) are used to prevent fibrosis after glaucoma filtration surgery. Anti-brain-derived neurotrophic factor aptamer has been used to diagnose glaucoma. The first approved aptamer drug (pegaptanib) has been used to inhibit angiogenesis in age-related macular degeneration (AMD) and diabetic retinopathy (DR), and its efficacy and safety have been demonstrated in clinical trials. Aptamers, including E10030, RBM-007, AS1411, and avacincaptad pegol, targeting other angiogenesis-related biomarkers have also been discovered and subjected to clinical trials. Aptamers, such as C promoter binding factor 1, CD44, and advanced end products in AMD and DR, targeting other signal pathway proteins have also been discovered for therapy, and biochemical sensors for early diagnosis have been developed based on aptamers targeting VEGF, connective tissue growth factor, and lipocalin 1. Aptamers used for early detection and treatment of ocular tumors were derived from other disease biomarkers, such as CD71, nucleolin, and high mobility group A. In this review, the development and application of aptamers in eye disorders in recent years are systematically discussed, which may inspire a new link between aptamers and eye disorders. The aptamer development trajectory also facilitates the discovery of the pathogenesis and therapeutic strategies for various eye disorders.

01 Dec 2021·Clinical & experimental ophthalmologyQ3 · MEDICINE

Intravitreous treatment of severe ocular von Hippel–Lindau disease using a combination of the VEGF inhibitor, ranibizumab and PDGF inhibitor, E10030: Results from a phase 1/2 clinical trial

Q3 · MEDICINE

Article

Author: Hwang, Christopher K. ; Keenan, Tiarnan D. L. ; Cukras, Catherine A. ; Chittiboina, Prashant ; Pacak, Karel ; Wong, Wai T. ; Wiley, Henry E. ; Linehan, W. Marston ; Chew, Emily Y.

Abstract:

Background:

Treatment options for severe ocular von Hippel–Lindau (VHL) disease are limited. This trial evaluated preliminary safety and potential efficacy of combination intravitreous injection with ranibizumab, a vascular endothelial growth factor (VEGF) inhibitor, and E10030, a PDGF inhibitor, for eyes with VHL disease‐associated retinal hemangioblastoma (RH) not amenable or responsive to thermal laser photocoagulation.

Methods:

This was a prospective, single‐arm, open‐label phase 1/2 study, comprised of three adults with VHL‐associated RH and vision loss. Intravitreous injections of ranibizumab (0.5 mg) and E10030 (1.5 mg) were given unilaterally every 4 weeks in the study eye through 16 weeks, then every 8 weeks through 48 weeks. Supplementary standard care therapies were allowed without restriction after 40 weeks. The primary outcome was the ocular and systemic adverse effect profile at 52 weeks. Secondary outcomes included changes in best‐corrected visual acuity (BCVA), RH size, exudation, epiretinal proliferation and retinal traction, and need for ablative treatment of RH or ocular surgery at week 52.

Results:

Three participants each received nine injections prior to week 52 and were followed for 104 weeks. One participant manifested mild episodic ocular hypertension in the study eye. Change in BCVA in the study eye at week 52 for the three participants was −5, −12 and +2 letters. No reduction in RH size was measured at 52 weeks. Variable mild improvements in exudation in two participants at week 16 were not sustained through week 52.

Conclusions:

Combination intravitreous injection with ranibizumab and E10030 demonstrated a reasonable preliminary safety profile, but limited treatment effect.

03 Jul 2017·Expert opinion on emerging drugsQ2 · MEDICINE

Emerging vascular endothelial growth factor antagonists to treat neovascular age-related macular degeneration

Q2 · MEDICINE

Review

Author: Hussain, Rehan M ; Ciulla, Thomas A.

INTRODUCTION:

Evolving anti-vascular endothelial growth factor (VEGF) treatments for neovascular age-related macular degeneration (nAMD) include long acting agents, combination strategies involving new pathways, topical agents, sustained-release, and genetic therapy strategies. Areas covered: Brolucizumab and abicipar pegol have smaller molecular size, facilitating higher concentrations and potentially longer duration than current anti-VEGF agents. Agents being combined with anti-VEGFs include OPT-302 (to inhibit VEGF-C and VEGF-D); pegpleranib and rinucumab (to inhibit platelet derived growth factor, PDGF - but both failed to show consistently improved visual outcomes compared to anti-VEGF monotherapy); and RG7716, ARP-1536 and nesvacumab (to activate the Tie-2 tyrosine kinase receptor, which reduces permeability). X-82 is an oral anti-VEGF and anti-PDGF being tested in phase 2 studies. Topical anti-VEGF ± anti-PDGF drugs under study include pazopanib, PAN-90806, squalamine lactate, regorafinib, and LHA510. Sustained-release anti-VEGF delivery treatments, such as the ranibizumab Port Delivery System, GB-102, NT-503, hydrogel depot, Durasert, and ENV1305 aim to reduce the burden of frequent injections. Gene therapies with new viral vectors hold the potential to induce sustained expression of anti-angiogenic proteins via the retina's cellular apparatus, and include AVA-101/201, ADVM-202/302, AAV2-sFLT01, RGX314, and Retinostat. Expert opinion: There are many emerging anti-VEGF treatments that aim to improve visual outcomes and reduce the treatment burden of nAMD.

3

News (Medical) associated with Pegpleranib Sodium

01 May 2023

·www.fiercebiotech.com

Astellas keeps the big buyouts rolling, inking $5.9B Iveric takeover ahead of FDA eye disease ruling

Astellas framed the deal to buy Iveric Bio as a way to further its focus on blindness and regeneration. The multibillion-dollar biotech buyouts keep on coming. Astellas Pharma is the latest drugmaker to get in on the act, agreeing to pay $5.9 billion to buy Iveric Bio and establish itself as a player in an emerging eye disease niche. Iveric is less than three months away from learning whether the FDA will approve avacincaptad pegol, a complement C5 protein inhibitor that reduced the rate of geographic atrophy (GA) progression in a phase 3 clinical trial. Patients with GA, a cause of irreversible loss of vision in patients with age-related macular degeneration (AMD), lacked treatments until recently, but the market is heating up fast. Apellis Pharmaceuticals won the first FDA approval for a GA drug, Syfovre, in February, and companies including AstraZeneca, Johnson & Johnson, Novartis and Roche are in pursuit. Iveric, a biotech formerly known as Ophthotech, is poised to be the first commercial rival to Apellis, though. That fact has caught Astellas’ attention. Astellas has agreed to pay $40 per share in cash to buy Iveric. The fee represents a 22% premium over Iveric’s closing price at the end of last week. That may seem light in the wake of the triple-digit premiums that GSK and Sanofi have paid recently for Bellus Health and Provention Bio, respectively, but it follows a steady rise in Iveric’s share price. The premium over Iveric’s March 31 share price is 64%. The willingness of Astellas to pay $5.9 billion for Iveric reflects the Japanese drugmaker’s desire to hit its 2025 sales target and need to add new growth drivers to offset the anticipated loss of revenue when the prostate cancer drug Xtandi loses patent protection in 2027. Astellas also framed the deal as a way to further its focus on blindness and regeneration. Cell and gene therapies are part of the strategy, but that side of the pipeline has stuttered, with enrollment in a phase 1 trial of GA candidate ASP7317 stopping for two years and a glaucoma prospect acquired in the Quethera buyout yet to reach the clinic. Buying Iveric will give Astellas a GA drug that could be approved by the time the deal closes in the third quarter and accelerate an expansion into ophthalmology by providing control of the commercial team and other infrastructure that the biotech has built up to support the launch. Earlier this year, Iveric said it was building a 120-person sales team that would include 50 to 70 field-based reps. The deal completes an impressive recovery for Iveric, which was on the ropes in 2017. Back then, a run of three clinical trial failures for Fovista sunk the biotech’s stock and wiped out the optimism generated when Novartis paid $200 million for ex-U.S. rights to the AMD asset. Yet, Iveric recovered, changing its name from Ophthotech and embarking on a GA strategy that culminates today in the Astellas buyout.

AcquisitionPhase 1Phase 3Drug Approval

05 Apr 2021

·www.biospace.com

Iveric Bio’s Co-Founder Leaves to Return to Venture Capitalist Role

IVERIC bio’s co-founder and Executive Chairman David R. Guyer is stepping down from his role to return to his first love – investing. He’ll make a return to his former role at SV Health Investors as a Venture Partner. In it from day one, Guyer has guided the company from the boardroom since the retinal disease company’s 2007 inception. Then named Ophthotech, Guyer also led as CEO from 2013-2017. Iveric has been through some highs and lows in Guyer’s time. After a somewhat promising Phase II combination trial, the company’s wet age-related macular degeneration (AMD) drug Fovista flopped badly in Phase III, failing to show any measurable benefit. Guyer had to make the tough call to cut 80% of staff, leaving its headcount at less than 50. From there, the company pivoted toward gene therapies, in-licensing a portfolio of eye disease-related treatments in development. This move led to the renaming of the Ophthotech to Iveric Bio, updating its Nasdaq symbol to the clever “ISEE” on the ticker. Iveric’s lead drug Zimura is a C5 inhibitor currently in development for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD). Zimura published positive Phase III results last fall and continues in a Phase II study for autosomal recessive Stargardt disease. “I am very excited about Iveric's phase 3 program of Zimura for the treatment of geographic atrophy secondary to age-related macular degeneration and look forward to continuing to serve the company as a senior advisor,” Guyer said. Guyer will remain a senior advisor to Iveric, without the weight of any executive powers. “As a co-founder, former Chief Executive Officer and most recently Executive Chair, David has been an integral part of Iveric Bio’s leadership, a trusted advisor and visionary in retinal medicine, and I sincerely thank him for his hard work and significant contributions to the Company,” stated Glenn P. Sblendorio, chief executive officer and president of Iveric Bio. “Iveric Bio's strong management team has evolved to the point where there is no longer a need for an Executive Chair,” Guyer added. “After more than 14 years on the Board, I feel that this is a good departure point such that I can return to my passion as a venture capitalist."

02 Mar 2017

·www.bioportfolio.com

Ophthotech Corp OPHT Pharmaceuticals Healthcare Deals and Alliances Profile Prices from USD $250

Summary Ophthotech Corp Ophthotech is a biopharmaceutical company that provides developing therapeutics for agerelated macular degeneration. The company's products include Fovista, an antiplateletderived growth factor PDGF, Zimura an anticomplemente is a central component of the complement cascade that is supposed to be involved in the development of AMD. Ophthotech utilizes aptamer technology, a single strands of nucleic acid to targets such as PDGF, comparable to a monoclonal antibody. The company's Fovista is used to inhibit abnormal new blood vessel growth associated with wet AMD. Ophthotech is headquartered in New York, the US. Ophthotech Corp OPHT Pharmaceuticals Healthcare Deals and Alliances Profile provides you comprehensive data and trend analysis of the company's Mergers and Acquisitions MAs, partnerships and financings. The report provides detailed information on Mergers and Acquisitions, Equity/Debt Offerings, Private Equity, Venture Financing and Partnership transactions recorded by the company over a five year period. The report offers detailed comparative data on the number of deals and their value categorized into deal types, subsector and regions. GlobalData derived the data presented in this report from proprietary inhouse Pharma eTrack deals database, and primary and secondary research. Scope Financial Deals Analysis of the company's financial deals including Mergers and Acquisitions, Equity/Debt Offerings, Private Equity, Venture Financing and Partnerships. Deals by Year Chart and table displaying information encompassing the number of deals and value reported by the company by year, for a five year period. Deals by Type Chart and table depicting information including the number of deals and value reported by the company by type such as Mergers and Acquisitions, Equity/Debt Offering etc. Deals by Region Chart and table presenting information on the number of deals and value reported by the company by region, which includes North America, Europe, Asia Pacific, the Middle East and Africa and South and Central America. Deals by Subsector Chart and table showing information on the number of deals and value reported by the company, by subsector. Major Deals Information on the company's major financial deals. Each such deal has a brief summary, deal type, deal rationale; and deal financials and target Company's major public companies key financial metrics and ratios. Business Description A brief description of the company's operations. Key Employees A list of the key executives of the company. Important Locations and Subsidiaries A list and contact details of key centers of operation and subsidiaries of the company. Key Competitors A list of the key competitors of the company. Key Recent Developments A brief on recent news about the company. Reasons to Buy Get detailed information on the company's financial deals that enable you to understand the company's expansion/divestiture and fund requirements The profile enables you to analyze the company's financial deals by region, by year, by business segments and by type, for a five year period. Understand the company's business segments' expansion / divestiture strategy The profile presents deals from the company's core business segments' perspective to help you understand its corporate strategy. Access elaborate information on the company's recent financial deals that enable you to understand the key deals which have shaped the company Detailed information on major recent deals includes a summary of each deal, deal type, deal rationale, deal financials and Target Company's key financial metrics and ratios. Equip yourself with detailed information about the company's operations to identify potential customers and suppliers. The profile analyzes the company's business structure, locations and subsidiaries, key executives and key competitors. Stay uptodate on the major developments affecting the company Recent developments concerning the company presented in the profile help you track important events. Gain key insights into the company for academic or business research Key elements such as break up of deals into categories and information on detailed major deals are incorporated into the profile to assist your academic or business research needs. Note*: Some sections may be missing if data is unavailable for the company.

AntibodyAcquisition

100 Deals associated with Pegpleranib Sodium

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KEGG	Wiki	ATC	Drug Bank
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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Dystrophy, Macular	Phase 3	BE	IVERIC bio, Inc.	01 Aug 2013
Dystrophy, Macular	Phase 3	DK	IVERIC bio, Inc.	01 Aug 2013
Dystrophy, Macular	Phase 3	CH	IVERIC bio, Inc.	01 Aug 2013
Dystrophy, Macular	Phase 3	TR	IVERIC bio, Inc.	01 Aug 2013
Dystrophy, Macular	Phase 3	GB	IVERIC bio, Inc.	01 Aug 2013
Wet age-related macular degeneration	Phase 3	US	Ophthotech Corp. (New Jersey)	01 Aug 2013
Wet age-related macular degeneration	Phase 3	AR	Ophthotech Corp. (New Jersey)	01 Aug 2013
Wet age-related macular degeneration	Phase 3	AU	Ophthotech Corp. (New Jersey)	01 Aug 2013
Wet age-related macular degeneration	Phase 3	AT	Ophthotech Corp. (New Jersey)	01 Aug 2013
Wet age-related macular degeneration	Phase 3	BE	Ophthotech Corp. (New Jersey)	01 Aug 2013

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02859441 (Pubmed \| Clin Exp Ophthalmol) Manual	Phase 1/2	Von Hippel-Lindau Disease	3	E10030+ranibizumab	yfkmcpakrp(gaqjvacsxv) = One participant manifested mild episodic ocular hypertension in the study eye kmsceimhav (slzdqnbvea ) View more	Negative	21 Sep 2021
NCT01940887 (OPH1004, CTgov)	Phase 3	Wet age-related macular degeneration	645	aflibercept+E10030+bevacizumab (E10030 + Bevacizumab or Aflibercept)	fqhjpfnjgz(pdipkxtslj) = illnjdxlvp gzwcqokivz (qsgguuclul, vkresakisk - sssaklqjyu) View more	-	30 Sep 2020
				aflibercept+E10030 sham injection+bevacizumab (Sham + Bevacizumab or Aflibercept)	fqhjpfnjgz(pdipkxtslj) = kwfufqmoct gzwcqokivz (qsgguuclul, nzuljjqgzf - klbuuzsmnp) View more
NCT02214628 (CTgov)	Phase 2	Wet age-related macular degeneration	101	Fovista (Fovista® (Anti-PDGF BB) Plus Anti-VEGF Simultaneous Regimen)	pgrqmopkah(veoefqfltn) = vdirraitsx upgroiksmk (wxtqhrmfiq, xoaqxrdkuc - nhojuezjlt) View more	-	10 Jul 2019
				Fovista (Fovista® (Anti-PDGF BB) Plus Anti-VEGF Pre-Treatment Regimen)	pgrqmopkah(veoefqfltn) = pmxfyiddux upgroiksmk (wxtqhrmfiq, yscwonvmzi - wvktoirzew) View more
NCT02387957 (CTgov)	Phase 2	Age Related Macular Degeneration	63	Fovista®+Bevacizumab (Fovista® Plus Bevacizumab)	ryeeevcwff(swoeoarvty) = kpcjjptmyi riwxzfaghq (thrsxquyot, svknnnuooy - bioeqksnaq) View more	-	05 Mar 2019
				ranibizumab+Fovista® (Fovista® Plus Ranibizumab)	ryeeevcwff(swoeoarvty) = ezbbtazzpt riwxzfaghq (thrsxquyot, aavqpefywb - wzdcfkzzir) View more
NCT01940900 (OPH1003, CTgov)	Phase 3	Wet age-related macular degeneration	627	ranibizumab+E10030 (E10030 + Ranibizumab)	ytofzgbuke(fzorbsvoni) = hnqmdmkbxd sttntofxtp (bmjjqtboxu, vagmmfkamc - kngcjgenvt) View more	-	15 Aug 2018
				ranibizumab+E10030 sham intravitreal injection (Sham + Ranibizumab)	ytofzgbuke(fzorbsvoni) = shvjjfnyks sttntofxtp (bmjjqtboxu, hxffsgywpe - plxfcxhvye) View more
NCT01944839 (OPH1002, CTgov)	Phase 3	Wet age-related macular degeneration	619	ranibizumab+E10030 (E10030 + Ranibizumab)	ezlarjxfat(glapuqgmyt) = cglhbcfwyh ezqysqrboc (aqybvhqmtb, ttkssqtbmz - gvwmpamyag) View more	-	10 Aug 2018
				ranibizumab+E10030 sham intravitreal injection (Sham + Ranibizumab)	ezlarjxfat(glapuqgmyt) = zlxrulkaqc ezqysqrboc (aqybvhqmtb, owkrjewgnv - ikycoylziv) View more
NCT01940887 (OPH1004, PipelineReview) Manual	Phase 3	Wet age-related macular degeneration	640	Aflibercept+Avastin+Fovista	gtdyfietkm(bybwjciile) = bdkcgknffw lxdutkbqgk (gvffymgogw )	Negative	15 Aug 2017
				Aflibercept+Avastin+Placebo	gtdyfietkm(bybwjciile) = nrmolakpbn lxdutkbqgk (gvffymgogw )
NCT01940900 (OPH1003, PipelineReview) Manual	Phase 3	Wet age-related macular degeneration	627	Ranibizumab+Pegpleranib Sodium	anxerkqjlc(rqddvfolju) = duwcxcyiml uisybpmsdz (bxpllgewcc )	Negative	12 Dec 2016
				Ranibizumab+Placebo	anxerkqjlc(rqddvfolju) = rlnydbfmzo uisybpmsdz (bxpllgewcc )
NCT01944839 (OPH1002, PipelineReview) Manual	Phase 3	Wet age-related macular degeneration	621	Ranibizumab+Pegpleranib Sodium	vjfeerofdv(emobrkmsna) = bkokkguzhm cvgrjxbnzz (dljmxrhiqi )	Negative	12 Dec 2016
				Ranibizumab+Placebo	vjfeerofdv(emobrkmsna) = lblmsiskpb cvgrjxbnzz (dljmxrhiqi )
Phase 2b Study of Fovista (ARVO2016)	Phase 2	Wet age-related macular degeneration	449	Fovista 0.3 mg with ranibizumab 0.5 mg	qjkqfmrsin(xlnsscnfwd) = wqxkryyaba ufmdsymepi (pkdymhjmkr ) View more	Positive	01 May 2016
				Fovista 1.5 mg with ranibizumab 0.5 mg	qjkqfmrsin(xlnsscnfwd) = hndsyyjyhl ufmdsymepi (pkdymhjmkr ) View more