Prophylactic Treatment: Lessdrops™ vs Standard Drops Regimen

Cataract surgery is one of the most commonly performed surgeries in the world today. To
improve the overall procedure outcome, prophylactic topical antibiotics and
anti-inflammatories (steroidal and non-steroidal, NSAID) are frequently used to decrease the
risk of postoperative infection (e.g., endophthalmitis) and intraocular inflammation (e.g.,
macular edema, CME).

Even though, the large body of literature that supports the significance of prophylactic eye
drops prior to surgery, patient compliance is a common problem. Different factors have been
associated with patient's lack of compliance. It could be due to patient's inability to self-
administer the drops, lack of understanding of the importance of using the prophylactic
treatment as well as understanding the instructions of how to administer the drops and its
storage, or just forgetfulness or the fact that they don't like to put the drops multiple
times a day for 2-4 weeks, therefore they just avoid doing it. About 64% of patients adhere
to the prescribed treatment.

There is a new alternative that combines the most commonly used antibiotic and
anti-inflammatories into a single drop. The use of a single drop compounded ophthalmic
solution may offer advantages such as increased compliance, patient comfort and reduced
ocular toxicity. T

The purpose of this study is to compare the Pred-Gati-Brom formulation to the standard
topical drops regimen that includes the topical use of Gatifloxacin, Bromfenac and
Prednisolone acetate 1%.

Inclusion Criteria:

- Subject is undergoing bilateral cataract extraction or refractive lens exchange with
intraocular lens implantation.

- Willing and able to provide written informed consent for participation in the study.

- Willing and able to comply with scheduled visits and other study procedures.

- Willing and able to administer eye drops and record the times the drops were
instilled.

- Scheduled to undergo standard cataract surgery with topical anesthesia in both eyes
within 6-15 days between surgeries.

- Potential postoperative best-corrected visual acuity of 20/30 or better.

Exclusion Criteria:

- Severe preoperative ocular pathology: amblyopia, rubella cataract, proliferative
diabetic retinopathy, shallow anterior chamber, macular edema, aniridia or iris
atrophy, uveitis, history of iritis, iris neovascularization, medically uncontrolled
glaucoma, microphthalmos or macrophthalmos, optic nerve atrophy, advanced macular
degeneration, advanced glaucomatous damage, etc.

- Uncontrolled diabetes.

- Use of any systemic or topical drug known to interfere with visual performance.

- Contact lens use during the active treatment portion of the trial.

- Any concurrent infectious/noninfectious conjunctivitis, keratitis or uveitis.

- History of chronic intraocular inflammation.

- History of retinal detachment.

- Pseudoexfoliation syndrome or any other condition that has the potential to weaken the
zonules.

- Any additional ocular surgical procedures at time of cataract extraction (i.e. iStent)
except corneal incisions for the correction of astigmatism.

- Anesthesia other than topical anesthesia (i.e. retrobulbar, general, etc).

- Any clinically significant, serious or severe medical or psychiatric condition that
may increase the risk associated with study participation or may interfere with the
interpretation of study results.

- Participation in (or current participation) any ophthalmic investigational drug or
device trial within the previous 30 days prior to the start date of this trial.

- Intraocular conventional surgery within the past three months or intraocular laser
surgery within one month.