Topical Infliximab in Autoimmune Eyes With Keratoprosthesis

This is an unmasked, prospective, multicenter clinical trial of four patients that are
candidates for a Boston Keratoprosthesis or have had prior KPro surgery and have a diagnosis
of Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis syndrome (TENS) or mucous
membrane pemphigoid (MMP). Only one eye per patient will be considered for inclusion.

This is a phase I/II study to evaluate the safety and tolerance of topical infliximab 10
mg/mL eye drops. Research subjects will be required to administer infliximab eye drops four
times per day for three months followed by twice daily administration for nine months. The
subjects will be monitored while on the study medication as well as for one year following
discontinuation of the drug. The total study duration for each patient will be two years.

Inclusion Criteria:

- Age between 18 and 80 years

- Able to provide informed consent

- Underlying diagnosis of SJS, TENS, or MMP

- Implantation of a Boston KPro type I

- Able to administer eye medications or have a care giver able and willing to do same

- Negative tuberculosis screening

Exclusion Criteria:

- Active or recurrent ocular or systemic infection

- Chest radiography, QuantiFERON-TB Gold or purified protein derivative (PPD)
evidence of active or latent tuberculosis infection

- Indeterminate initial and repeat QuantiFERON-TB Gold results

- History of Bacille Calmette-Guerin (BCG) vaccination within twelve months of
screening

- History of latent or active granulomatous infection, including histoplasmosis or
coccidioidomycosis, prior to screening

- Chest radiograph within three months prior to the first administration of the
study drug that shows an abnormality suggestive of a malignancy or current
active infection, including tuberculosis.

- History of a nontuberculous mycobacterial infection or opportunistic infection
(e.g. cytomegalovirus, pneumocystosis, aspergillosis) within six months prior to
screening

- history of hepatitis B virus

- Methicillin resistant Staphylococcus aureus (MRSA) or vancomycin resistant
enterococcus (VRE) infection

- Malignancy diagnosed in the last five years

- Demyelinating disease

- History or current diagnosis of diabetes mellitus (controlled and uncontrolled)

- Heart failure (New York Heart Association class III or IV)

- Pregnancy or breast-feeding

- Scheduled to receive a live vaccine at any time point during study participation

- Allergy to infliximab or any of the compounds in its topical formulation or any
chemically-related medication

- Prior or current use of systemic anti-tumor necrosis alpha-α medications or currently
receiving treatments of Kineret (Anakinra)

- KPro designs with less than 16 holes in the back plate (to avoid the confounder of
corneal nutrition)

- Inability to comply with the instillation of additional drops

- Unable to attend postoperative visits or administer medications, or no care giver
available and willing to assist with same