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REGN7041: an investigational biologic for noninfectious uveitis

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In short

REGN7041 is an investigational protein-based medicine being studied for noninfectious uveitis, a form of inflammation inside the eye. In one completed Phase 1/2 trial, the substance was tested in 29 adult participants with active disease to assess safety and tolerability. The product records show no marketing authorisation, meaning REGN7041 is not yet an approved medicine.

REGN7041 is an investigational protein-based substance being developed by Regeneron Pharmaceuticals, Inc. for the treatment of noninfectious uveitis, a form of inflammation inside the eye. The product records show no marketing authorisation, meaning REGN7041 is not yet an approved medicine.

Key points

  • REGN7041 is an investigational protein-based substance developed by Regeneron Pharmaceuticals.
  • It is being studied for noninfectious uveitis, an inflammatory eye condition.
  • One Phase 1/2 trial has been completed, enrolling 29 adult participants.
  • The trial measured treatment-emergent adverse events as its primary outcome.
  • REGN7041 is given by intravitreal injection, directly into the eye.
  • The substance has no marketing authorisation and remains investigational.

What is REGN7041?

REGN7041 is a protein-based substance, classified in the registry as a protein of non-chemical origin. It is listed under the therapeutic area of eye diseases. The substance is also known by its development code REGN7041, which is the only name appearing in the product records. REGN7041 is an investigational substance with no marketing authorisation in the product records. The authorisation holder and supplier of the product is Regeneron Pharmaceuticals, Inc.

How does REGN7041 work?

The available registry data do not describe the molecular target or mechanism of action of REGN7041. The trial record focuses on safety and tolerability rather than explaining how the substance acts inside the eye. REGN7041 is administered directly into the vitreous, the gel-like substance filling the eye, which is known as intravitreal use.

Which conditions is REGN7041 used or studied for?

  • Noninfectious uveitis — inflammation of the uvea, the middle layer of the eye, that is not caused by an infection. The trial enrolled participants with active noninfectious uveitis affecting the posterior segment of the eye.

How is REGN7041 given?

REGN7041 is formulated as a solution for injection and is given by intravitreal use, meaning it is injected directly into the vitreous of the eye. The trial evaluated single and repeated doses of intravitreally administered REGN7041.

What do the clinical trials show?

One clinical trial of REGN7041 is recorded, a Phase 1/2 study that has been completed. The trial enrolled 29 adult participants with active noninfectious uveitis of the posterior segment. The primary outcome was the occurrence of treatment-emergent adverse events, also called TEAEs, which are side effects that appear or worsen after treatment begins. The study aimed to evaluate the ocular and systemic safety and tolerability of single and repeated intravitreal doses of REGN7041. The trial status is completed, but the registry record does not report efficacy results.

What side effects are known?

The registry record does not provide a list of side effects observed in the trial. The primary outcome of the study was the occurrence of treatment-emergent adverse events, which means the trial was designed to collect safety information. No specific side effects are reported in the available data.

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