BRM421 Ophthalmic Solution in Patients With Limbal Stem Cell Deficiency

February 12, 2026 updated by: BRIM Biotechnology Inc.

Intermediate-Size Patient Population Use of BRM421 Ophthalmic Solution in Patients With Limbal Stem Cell Deficiency

The goal of this program is to provide patients with Limbal Stem Cell Deficiency access to the BRM421 eye drops.

Participants will:

  • Use BRM421 two times a day for at least 12 weeks
  • Visit the clinic monthly for checkups and tests

Study Overview

Status

Available

Conditions

Intervention / Treatment

Study Type

Expanded Access

Expanded Access Type

  • Intermediate-size Population

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Available
        • Scheie Eye Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Description

Inclusion Criteria:

  • Adult patients with mild to moderate LSCD who unsatisfied with the standard of care treatments and who seek the treatment with BRM421 Ophthalmic Solution. Patients scheduled for LSC transplant may be included, but treatment with BRM421 should begin only after the surgery.
  • Be able to sign the informed consent and follow with investigator instructions.
  • If a female is of childbearing potential, they must: use an acceptable means of birth control (acceptable methods of contraception include: hormonal oral, implantable, injectable, or transdermal contraceptives, mechanical spermicide in conjunction with a barrier such as a diaphragm or condom, IUD, or surgical sterilization of partner) and have a negative urine pregnancy test at the time of consent.

Exclusion Criteria:

  • The patients eligible for the BRIM clinical trial(s).
  • The patients diagnosed with primary LSCD which is the genetic mutations that lead to LSC dysfunction or destruction.
  • Have a condition or a situation in which the investigator feels the patients is not suitable and may put the patient at significant risk.
  • Be a female who is pregnant, nursing, or planning a pregnancy at the time of consent. Be a woman of childbearing potential who is not using an acceptable means of birth control; acceptable methods of contraception include: hormonal oral, implantable, injectable, or transdermal contraceptives; mechanical spermicide in conjunction with a barrier such as a diaphragm or condom; IUD; or surgical sterilization of partner. The risks of BRM421 among pregnant patients are not known.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

BRIM Biotechnology Inc.

Collaborators

University of Pennsylvania

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

December 2, 2025

First Submitted That Met QC Criteria

February 12, 2026

First Posted (Actual)

February 20, 2026

Study Record Updates

Last Update Posted (Actual)

February 20, 2026

Last Update Submitted That Met QC Criteria

February 12, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 859634
  • BRM421-25-EA002 (Other Identifier: BRIM Biotechnology)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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