Purpose:

To investigate the clinical safety and efficacy of subcutaneouos HP Acthar gel as adjunctive treatment in subjects with moderate to severe dry eye disease unresponsive or incompletely treated with traditional medications.

Methods:

Twelve subjects with moderate to severe dry eye uncontrolled on stable doses of standard dry eye treatments received 40-80 units of HP Acthar Gel IM or SC for 12 weeks. Subject evaluations included subject rated assessment of ocular discomfort, erythema, best corrected visual acuity, corneal and conjunctival staining and intraocular pressure. subjects with a history of ocular or systemic viral, fungal disease or tuberculosis, scleroderma, those who were immunocompromised or with uncontrolled cardiac disease, uncontrolled hypertension or diabetes and those with active peptic ulcer disease, cirrhosisor thyroid disease were excluded.

Results:

At 80 units given twice weekly, SANDE scores declined fom 69 at baseline to 44 at final visit (p=0.02), corneal fluorescein score reduction and Schirmer's testing both improved with p<0.08. erythema="" reduction="" was="" statistically="" significant="" at=""><0.001 and="" conjunctival="" lissamine="" green="" staining="" and="" intraocular="" pressure="" measurements="" (avg="" decrease="" in="" iop="" 2="" mm="" hg)="" showed="" downward="" trends="" but="" not="" statistically="" significant.="" time="" to="" response="" was="" 14="" d="" for="" sande="" and="" 7="" days="" for="" k="" and="" conj="" staining.="" bcva="" was="" stable.="" no="" ocular="" adverse="" events="" occurred.="" serious="" adverse="" event="" occurred="" (arrythmia)="" in="" a="" patient="" with="" a="" history="" of="" controlled="" cardiac="" arrhythmia="" and="" drug="" relation="" could="" not="" be="" ruled="" out.="" and="" conjunctival="" lissamine="" green="" staining="" and="" intraocular="" pressure="" measurements="" (avg="" decrease="" in="" iop="" 2="" mm="" hg)="" showed="" downward="" trends="" but="" not="" statistically="" significant.="" time="" to="" response="" was="" 14="" d="" for="" sande="" and="" 7="" days="" for="" k="" and="" conj="" staining.="" bcva="" was="" stable.="" no="" ocular="" adverse="" events="" occurred.="" serious="" adverse="" event="" occurred="" (arrythmia)="" in="" a="" patient="" with="" a="" history="" of="" controlled="" cardiac="" arrhythmia="" and="" drug="" relation="" could="" not="" be="" ruled="">

Conclusions:

This is a small scale, single armed prospective adjunctive treatment trial evaluating patients with moderate to severe dry eye uncontrolled or inadequately controlled with traditional treatments. Pilot study results suggest that repository corticotropin gel can be effective and safe with good tolerability and no increase in intraocular pressure.