Multi-Center, Prospective, Non-Interventional Study in Subjects With Limbal Stem Cell Deficiency

A Multi-Center, Prospective, Non-Interventional Study in Subjects With Limbal Stem Cell Deficiency

The goal of this non-interventional, observational study is to describe the natural history, clinical course, and management patterns of subjects with limbal stem cell deficiency (LSCD).

Inclusion Criteria:

• A photopic BCVA in the prospective study eye(s) of ≤ 70 letters at the Screening and Day 1 visits AND a change of ≤ 10 letters in photopic BCVA at Day 1 compared to the Screening Visit
• Qualifying LSCD diagnosis in the study eye(s) prior to enrollment at Day 1
• Written confirmation that exclusions on retinal findings are met in the study eye(s) prior to enrollment at Day 1
• Inflammation associated with LSCD or other non-infectious inflammation (e.g., dry eye, ocular rosacea, and blepharitis) that will not interfere with the subject's participation in the opinion of the investigator is permitted.

Exclusion Criteria:

• Any active ocular infection in either eye at either the Screening or Day 1 visits
• Active sterile iritis or uveitis in either eye at Screening or Day 1 visits
• Screening visit retinal exam finding, in the opinion of the investigator, that would limit potential for visual acuity gain in the study eye(s)

Note: Other inclusion/exclusion criteria apply.