KB803-EYE-01 is a Phase 3 double-blind, randomized, placebo-controlled, crossover study to evaluate the safety and efficacy of KB803 versus matched placebo in pediatric and adult subjects with recurrent corneal abrasions due to dystrophic epidermolysis bullosa (DEB).
The subject and/or their parent/legal guardian must provide informed consent/assent and must be able to and willing to follow study procedures and instructions.
Age 6 months or older at time of informed consent/assent.
Confirmed diagnosis of DEB with a mutation in the COL7A1 gene.
Meets minimum corneal abrasion symptom frequency in the NHS study.
Initiation of any new treatment regimen or change in treatment for ocular disease during the run-in period except for preservative free topical antibiotics or artificial tears/lubricants associated with standard of care treatment of corneal abrasions.
Treatment with an investigational agent or off-label ophthalmic use of an approved product during the run-in period or planned use during the study (Exceptions may be approved by the medical monitor on a case-by-case basis).
Any condition that, in the opinion of the Investigator, would impact the completion of all study-related assessments, interfere with the administration of study drug, and/or poses an additional risk to the subject.
Women who are pregnant or nursing.
Crossover
KB803
Biological/VaccineOphthalmic suspension of replication-defective, non-integrating herpes simplex virus (HSV-1) expressing the human collagen VII protein
Placebo
DrugVehicle
To evaluate the safety and tolerability of KB803.
Number of subjects with treatment related adverse events as assessed by CTCAE v5.
To evaluate the effect of ophthalmic KB803 on frequency of corneal abrasion symptoms.
Average number of days per month with corneal abrasion symptoms.
To evaluate the effect of ophthalmic KB803 on eye pain.
Average weekly eye pain score. Pain will be measured using a numerical scale with 0 being no hurt through 10 being the worst hurt.
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