Effect of Exeporfinium Chloride (XF-73) Gel on Nasal S.Aureus in Patients at Risk of Post-op Staphylococcal Infection

Individuals who meet all of the following criteria are eligible to participate in the
study.

1. Male or female patients between 18 and 75 years of age.

2. Patients who are confirmed nasal S. aureus carriers by polymerase chain reaction
(PCR) screen assay, and due to undergo surgical procedure.

3. Patients who are willing to provide written informed consent.

4. Patients who are willing and able (as per Investigator judgment) to complete all
protocol specified visits and assessments.

5. Woman of childbearing potential* with a negative urine pregnancy test (sensitive to
25 IU human chorionic gonadotropin (hCG)).

- Women of childbearing potential are defined as those women between menarche and
menopause who have not undergone permanent sterilisation. Permanent
sterilisation methods include hysterectomy, bilateral salpingectomy, and
bilateral oophorectomy.

Individuals who meet any of the following criteria are not eligible to participate in the
study.

1. Pregnancy (current) or currently lactating.

2. Uncontrolled acute or chronic illness (as determined by the investigator) in
addition to those requiring the planned surgical intervention.

3. History of atopy, allergic reactions or hypersensitivity to the study medication or
its components.

4. Current upper respiratory tract infection, cold or influenza with significant nasal
symptoms that might impact on the patient's ability to comply with the gel
application procedure.

5. History of photosensitivity.

6. Family history of porphyria.

7. Use of intra-nasal topical or systemic antibiotics or anti-infectives within the
last 4 weeks before screening. (Patients who screen positive for nasal carriage of
S. aureus and receive topical or systemic antibiotics or anti-infectives which are
not part of their prophylactic peri-operative SOC between screening and first dose
of investigational medicinal product (IMP) will be excluded from the study.) The use
of intra-nasal antibiotics or anti-infectives other than the study medication prior
to surgery is not allowed.

8. Use of other prescribed or over the counter nasal medication in the last 14 days, or
oral decongestants in the last 7 days before first administration of study drug.

9. Participation in a clinical trial within the last 12 weeks before first
administration of study drug.

10. Contemporaneous clinically significant abnormalities in vital signs or laboratory
analyses reported within 14 days prior to randomization which in the opinion of the
Investigator would preclude from the safety assessment of the medication under
study.

11. Nasal polyps or significant anatomical or other nasal abnormality that would prevent
from appropriate administration of the study treatment or represent an excessive
risk for the patient's participation.

12. History of nasal surgery including cauterization.

13. A recent history of frequent epistaxis and/or an episode of epistaxis within 3
months of the planned surgery.

14. Use of in situ nasal jewellery or existence of open nasal piercings.