Topical Fibrinogen-Depleted Human Platelet Lysate in Patients With Dry Eye Secondary to Graft vs. Host Disease

The purpose of this Phase 1/2 study is to compare the safety and tolerability of four times a day (QID) dosing of a non-preserved topical ocular drop formulation of 10 vol/vol % and 30 vol/vol % of FD hPL to vehicle control eye drops in patients with Dry Eye Disease (DED) secondary to Graft vs. Host Disease (GvHD).

Inclusion Criteria: 1. Male or female patients, of age 18 years (inclusive) or older at the time of signing the ICF; 2. Diagnosis of DED secondary to GvHD following allogeneic hematopoietic stem cell transplantation as determined by medical history 3. For females: 1. Be of non-child-bearing potential. Surgically sterilized (e.g., hysterectomy or bilateral oophorectomy) for at least 6 months prior to screening or postmenopausal (postmenopausal women must have no menstrual bleeding for at least 1 year prior to screening) and menopause will be confirmed by a plasma FSH level of \>40 IU/L) or 2. Women of childbearing potential must be non-lactating and agree to use a highly effective acceptable form of birth control (e.g., established hormonal birth control plus a barrier method, double barrier method: intrauterine device plus condom or spermicidal gel plus condom) from 21 days prior to dosing until 7 days after dosing, and 3. Women with a negative pregnancy test (β-hCG assay) in urine at screening and Day 1 predose; 4. Schirmer tear test with anesthesia \