Iontophoretic Delivery of EGP-437 in Patients Who Have Undergone Cataract Surgery

This will be a Phase 2b, double-masked, multi-site study, in which a total of up to 100 eyes of up to 100 subject will be enrolled at up to 8 clinical sites in the United States. The study has 2 different treatment arms consisting of the following iontophoresis treatment regimen:

Treatment Arm 1, up to 50 subjects will receive the following study treatment:

40 mg/ml dexamethasone phosphate solution delivered by iontophoresis treatment consisting of 4.5 mA-min at 3.0 mA on Day 0 (immediately following cataract surgery), Day 1 (24 hours' post-cataract surgery), Day 4, and a potential Day 7 treatment that will be administered for subjects who have ≥11 AC cells per high-power field on slit lamp examination.

Treatment Arm 2, up to 50 subjects will receive the following study treatment:

100 mM sodium citrate buffer solution (placebo) delivered by iontophoresis treatment consisting of 4.5 mA-min at 3.0 mA on Day 0 (immediately following cataract surgery), Day 1 (24 hours' post-cataract surgery), Day 4, and a potential Day 7 treatment that will be administered for subjects who have ≥11 AC cells per high-power field on slit lamp examination.

Subjects will come in for 6 visits over 28 days.

The primary efficacy endpoint (PEP) will evaluate 1) the proportion of subjects with an AC cell count of zero on Day 7 and 2) the proportion of subjects with a pain score of zero on Day 1.

Inclusion criteria

• Undergoing unilateral cataract extraction and implantation of a monofocal IOL (at the time of enrollment)
• Age 18 to 85 years
• Receive, understand, and sign a copy of the written informed consent form (ICF)
• Are able to return for all study visits and willing to comply with all study-related instructions

Exclusion criteria

• Are undergoing implantation of a multifocal and/or depth enhancing IOL
• Are undergoing or have just undergone cataract surgery on the study eye that is deemed complex or may require manipulation of the iris
• The study eye has a small pupil or iris requiring manipulation due to synechiae and/ Tamsulosin (Flomax®, Boehringer Ingelheim) use
• Have a Seidel positive wound following surgical procedure despite suture and/or ReSure® Sealant placement
• Have had ocular surgery of any kind in the study eye within 3 months prior to baseline visit (Day 0)
• Have undergone cataract surgery in the fellow eye within 4 weeks prior to baseline visit (Day 0) and still require post-operative medications in that fellow eye
• Are scheduled for surgery in the fellow eye within the study period
• Have anterior chamber inflammation as measured by slit lamp examination in the study eye at the baseline visit (Day 0) [Defined as anterior chamber (AC) cell and/or flare grade > 0]
• Have history of uveitis or inflammatory disease in the study eye
• Requires simultaneous supplemental surgery, such as glaucoma procedures or vitrectomy, in the study eye
• Have used any topical ocular medication in either eye, other than tear substitute for dry eye, within the past 2 weeks prior to baseline visit (Day 0)
• Have used topical corticosteroid or nonsteroidal anti-inflammatory drug (NSAID) treatment in either eye < 48 hours prior to the baseline visit (Day 0) (excluding the use of topical NSAIDs, pre-operatively on Day 0 and administered at the clinic site under the investigator's oversight)
• Have IOP ≥ 25 mmHg at baseline, a history of glaucoma, and/or require ocular anti-hypertensive medications
• Are known corticosteroid IOP responder in study eye
• Have received systemic administration of corticosteroid and/or immunosuppressants within the past 14 days prior to baseline visit (Day 0)
• Have received intravitreal, sub-Tenon, or any periocular corticosteroid treatment in either eye within the past 6 months prior to baseline visit (Day 0)
• Have open wounds/skin disease on the forehead area where the iontophoresis return electrode will be applied
• Have lesions of the eyelids or the ocular surface impeding the application of the iontophoresis applicator
• Have blepharospasm, blepharophimosis, or other eyelid anatomic variations precluding placement of the iontophoresis applicator
• Have known allergy to dexamethasone or dexamethasone phosphate or any medication to be used in this study
• Have history or diagnosis of ocular herpes, corneal lesion of suspected herpetic origin that could be worsened with steroid use
• Have optic neuritis of any origin
• Have clinically suspected or confirmed central nervous system or ocular lymphoma
• Have active hyphema, pars planitis, choroiditis, toxoplasmosis scar, vitreous hemorrhage, and/or clinically significant macular edema (CSME) that would compromise visual acuity recovery
• Have severe/serious ocular pathology or medical condition which may preclude study completion
• Have pacemaker and/or any other electrical sensitive support system
• Are pregnant or lactating female, or female of childbearing age and using inadequate birth control method
• Have participated in another investigational device or drug study within 30 days of baseline visit (Day 0) (other clinical trial participation while participating in EGP-437-009 would be prohibited per protocol)
• Have previously participated in a study with EGP-437