The goal of this program is to provide patients with Limbal Stem Cell Deficiency accessto 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
Not Provided
Drug: BRM421 Ophthalmic Solution, 0.06%
Patients eligible to participate will receive 0.06% BRM421 Ophthalmic Solutions to be
administered two times daily (BID, morning and bedtime) on the eligible eye(s). The
administration will be at least 12 weeks. The investigator may continue the treatment
beyond the 12 weeks based on clinical response. For patients scheduled for LSC
transplant, treatment with BRM421 should start only after surgery.
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.
Scheie Eye Institute
Philadelphia 4560349, Pennsylvania 6254927, United States
Investigator: Bennie Jeng, MD
Emma Iacobucci
215-662-9393
emma.iacobucci@pennmedicine.upenn.edu
Not Provided