I-ZIP Ocular Bandage Pivotal Study

Inclusion Criteria:

- Subject has a cataract and is expected to undergo unilateral clear corneal cataract
surgery with phacoemulsification and implantation of a posterior chamber monofocal
intraocular lens through an incision ≤ 3.5mm in width measured after IOL implantation
using internal calipers.

Exclusion Criteria:

- Any intraocular inflammation in the study eye that was present during the screening
slit-lamp examination or presence of ocular pain in the operative eye as rated on the
pre-operative NRPS

- Previous surgery (laser or incisional) or ocular trauma to the operative eye or
planned multiple procedures during cataract/IOL implantation surgery

- Potential BCVA in fellow eye worse than 20/40 as assessed by the clinical Investigator

- Active or history of chronic or recurrent inflammatory eye disease (iritis, scleritis,
uveitis, iridocyclitis, rubeosis iritis), evidence of acute external ocular
infections, intraocular infection, dysthyroid ophthalmopathy, nasolacrimal duct
obstruction, active chalazion, uncontrolled blepharitis, uncontrolled and clinically
significant dry eye syndrome, anything more than trace guttata (>10 guttae in the
central 6 mm of cornea), evidence of glaucoma/glaucoma suspect, corneal dystrophy or
other ocular disease that would interfere with study evaluations

- Subject is currently receiving antineoplastic therapy

- Use of topical ocular steroids within 14 days and/or systemic steroids (excluding
inhalants) within 30 days prior to surgery.

- Subject is an insulin-dependent diabetic or has background diabetic retinopathy (BDR),
proliferative diabetic retinopathy (PDR) or compromised macular function