The Efficacy and Safety of IBI-10090 for the Treatment of Inflammation Associated With Cataract Surgery

A double blinded randomized trial to assess the efficacy and safety of IBI-10090, in two separate doses as compared to placebo (ATEC carrier only sans dexamethasone)

Inclusion criteria

• The patient must provide written informed consent by signing the Informed Consent approved by the Institutional Review Board (IRB).
• Male or female patients at least 40 years of age scheduled for unilateral cataract surgery by phacoemulsification with posterior chamber intraocular lens implantation.
• The patient must demonstrate best corrected visual acuity (BCVA) of 20/30-20/200 (with glare testing, if necessary) in the study eye and better than 20/200 in the fellow eye.
• The patient must be considered by the Investigator to have visual acuity potential greater than 20/30 in the study eye.
• The patient must have a corneal endothelial cell count by specular microscopy in the study eye of at least 2000 cells/mm2 with normal cell morphology.
• A female patient of childbearing potential (premenopausal by medical history) must have a negative pregnancy test on Day 0 and be using an effective method of birth control (although no birth control method is 100% effective, the following are considered effective means of contraception: surgical sterilization, use of oral contraceptives, barrier contraception using either a condom or diaphragm with spermicidal gel, an intrauterine device, or contraceptive hormone implant or patch) from Screening for the duration of the study.
• The patient must be willing and able to understand and comply with the study procedures and to communicate meaningfully with study personnel.

Key Exclusion Criteria:

• Patients who have used any ocular, topical or oral corticosteroids within 7 days prior to Day 0.
• Patients who have received a periocular corticosteroid injection in the study eye in the 3 months prior to screening.
• Patients who have received any intravitreal corticosteroid delivery vehicle (e.g., Retisert, Ozurdex, Iluvien) in the study eye at any time.
• Patients who anticipate requiring treatment with any corticosteroids by any route, except inhalation, during the study.
• Patients with an allergy or hypersensitivity to dexamethasone.
• Patients who are known steroid responders (corticosteroid-related intraocular pressure elevation in either eye).
• Patients who have used topical ocular NSAIDs in the study eye within 15 days prior to Day 0.
• Patients who have undergone prior intraocular (non-laser) surgery in the study eye within 6 months prior to screening.
• Patients who have undergone prior intraocular laser surgery in the study eye within 3 months prior to screening.
• Patients with planned intraocular or laser surgery in the study eye for the duration of the study.