Delving into the Latest Updates on Tiespectus with Synapse

Overview

Basic Info

Drug Type

Bispecific antibody

Synonyms

EYE-201, MK-8748

Target

Tie-2 x VEGF

Action

agonists, inhibitors

Mechanism

Tie-2 agonists(TEK receptor tyrosine kinase agonists), VEGF inhibitors(Vascular endothelial growth factor inhibitors)

Therapeutic Areas

Cardiovascular DiseasesCongenital DisordersEndocrinology and Metabolic Disease+ [2]

Active Indication

Choroidal NeovascularizationWet age-related macular degenerationWet Macular Degeneration+ [3]

Inactive Indication-

Originator Organization

Eyebiotech Ltd.

Active Organization

Eyebiotech Ltd.

Inactive Organization-

License Organization-

Drug Highest PhasePhase 2/3

First Approval Date-

Regulation-

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Researchers are looking for new ways to treat neovascular age-related macular degeneration (NVAMD).
Available standard (usual) treatments for NVAMD, such as aflibercept, may not work for every person. Researchers want to learn if a trial medicine called tiespectus (also called MK-8748 or EYE201) can treat NVAMD.
The goal of this trial is to learn if tiespectus works as well as aflibercept to treat NVAMD.

Start Date31 Mar 2026

Sponsor / Collaborator

Eyebiotech Ltd.

NCT06664502

/ RecruitingPhase 1/2

A Phase 1/2a 2-part Study Consisting of an Open-label Multiple Ascending Dose (MAD) Safety Study in Participants With Macular Edema Following Branch Retinal Vein Occlusion (BRVO), and a Dose-finding, Double-masked, Comparative Safety, and Preliminary Efficacy Study of Intravitreal (IVT) EYE201 (Tiespectus) in Participants With Either Diabetic Macular Edema (DME) or Neovascular Age-related Macular Degeneration (NVAMD)

EYE-TIE-201 is a 2-part study to investigate the safety and effectiveness of a new drug being developed called EYE201.
All participants in the study will receive a total of 3 injections of EYE201 into the study eye, spaced at 4 weeks apart.
In the first part, termed the multiple ascending dose (MAD) portion of study, the safety of EYE201 will be assessed at increasing doses in branch retinal vein occlusion (BRVO) participants. Approximately 12 participants will be entered in this part of the study.
In the second part of the study, called the dose finding part, 2 doses of EYE201 will be selected and their effectiveness will be compared. This portion of the study assesses the safety and preliminary efficacy of EYE201 in patients with diabetic macular edema (DME) or neovascular macular degeneration (NVAMD). Approximately 80 participants will be entered in this part of the study.

Start Date12 Nov 2024

Sponsor / Collaborator

Eyebiotech Ltd.

100 Clinical Results associated with Tiespectus

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100 Translational Medicine associated with Tiespectus

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100 Patents (Medical) associated with Tiespectus

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100 Deals associated with Tiespectus

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Choroidal Neovascularization	Phase 3	-	Eyebiotech Ltd.	31 Mar 2026
Wet age-related macular degeneration	Phase 3	-	Eyebiotech Ltd.	31 Mar 2026
Wet Macular Degeneration	Phase 3	-	Eyebiotech Ltd.	31 Mar 2026
Diabetic macular oedema	Phase 2	United States	Eyebiotech Ltd.	12 Nov 2024
Macular Edema	Phase 2	United States	Eyebiotech Ltd.	12 Nov 2024
Retinal Vein Occlusion	Phase 2	United States	Eyebiotech Ltd.	12 Nov 2024

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT06664502 (RIOJA, NEWS) Manual	Phase 1/2	Retinal vein occlusion-related macular edema	12	Tiespectus 1 mg	szqrtbkhay(ndkeyfagmh) = no serious ocular or systemic adverse events occurred auaszvzsrc (kyveutijzk ) View more	Positive	19 Oct 2025
				Tiespectus 4 mg

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Clinical Trial

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Approval

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Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

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