Study to Evaluate the Safety and Efficacy of CSB-001 Ophthalmic Solution 0.1% in Neurotrophic Keratitis Subjects

Inclusion Criteria:

• Subjects with stage 2 (PED) or stage 3 (corneal ulcer) neurotrophic keratitis (NK).Subjects with bilateral NK may enroll in the study but only one eye will be selectedas the study eye (worse eye) and be treated with test article.

• Subjects with no clinical evidence of improvement in the PED or corneal ulcer withinthe 2 weeks prior to study enrollment despite the use of conventional non-surgicaltreatments for neurotrophic keratitis (e.g., preservative-free artificial tears,gels or ointments; discontinuation of preserved topical drops and medications thatcan decrease corneal sensitivity; therapeutic contact lenses [either siliconehydrogel or rigid gas permeable]) as determined by the investigator or referringphysician's medical record.

• Subjects with clinical evidence of decreased corneal sensitivity within the area ofthe PED or corneal ulcer and outside of the area of the defect in at least onecorneal quadrant in the study eye in the opinion of the investigator assessed with acotton wisp.

• Pinhole distance visual acuity score ≤ 75 ETDRS letters measured with a LogMAR chart (≥ 0.2 LogMAR, ≤ 20/32 Snellen or worse Snellen or ≤ 0.625 decimal fraction) in thestudy eye.

• Subjects must have the ability and willingness to comply with study procedures.

Exclusion Criteria:

• Any active ocular infection (bacterial, viral, fungal, or protozoal) or activeocular inflammation not related to NK in either eye in the opinion of theinvestigator. Infectious epithelial keratitis including herpetic keratitis (i.e.,dendritic lesions or geographic ulcers) in either eye is excluded. Subjects on oralantibiotic at the time of screening are eligible but should continue the medicationfor the duration of the study.

• Previous use of Oxervate in the study eye with last administration within the past 2months.

• Any other ocular disease, except glaucoma, that will require topical oculartreatment in the study eye over the course of the study.

• Use of any other topical treatments other than the study medication provided by theSponsor and allowed by the study protocol can be administered to the study eye overthe course of the study. The following are exceptions: a) Allowance for use ofpreservative-free antibiotic eye drops if prescribed by the investigator and b)Allowance for use of a non-preserved IOP-lowering prostaglandin topical ocular dropadministered once-daily (QD) in glaucomatous eyes over the course of the study.

Note: Other inclusion/exclusion criteria apply.