Acular LS®

GoodRx

Ketorolac 0.4% · ophthalmic solution

NSAID

Approved uses

Ocular pain and burning or stinging after corneal refractive surgery

One drop QID in the operated eye as needed, for up to 4 days postoperatively.

Post-PRK pain control equals bromfenac 0.09% BID, with no difference in epithelial healing.

OFF-LABELNot in the FDA label for this product

Cystoid macular edema prophylaxis with cataract surgery

One drop QID for 3 days preoperatively, 4 doses within the hour before surgery, then QID for about 4 weeks postoperatively, added to prednisolone acetate 1% QID.

RCT · n=546 · low-risk eyes

Prospective randomized investigator-masked multicenter trial in 546 patients with no recognized CME risk factors. Clinically apparent CME in 0 of 268 on the NSAID plus steroid versus 5 of 278 on steroid alone (p = 0.032); definite or probable CME on OCT in 0 versus 6 (2.4%, p = 0.018); mean retinal thickening 3.9 versus 9.6 microns (p = 0.003), with more than 10 microns of thickening in 26% versus 51% (p < 0.001). Good-quality single trial in low-risk eyes; the broader class evidence is graded low certainty by Cochrane.

Wittpenn JR, Silverstein S, Heier J, Kenyon KR, Hunkeler JD, Earl M. A randomized, masked comparison of topical ketorolac 0.4% plus steroid vs steroid alone in low-risk cataract surgery patients. Am J Ophthalmol. 2008;146(4):554-560.

Preoperative dosing to reduce LASIK pain

One drop QID starting 48 hours before surgery, one drop just before the keratome pass, and one drop at the conclusion of surgery.

RCT · n=30 · single surgeon

Prospective randomized double-masked contralateral-eye trial in 60 eyes of 30 patients, fellow eye on artificial tears: mean postoperative pain 0.53 versus 1.23 on a 0 to 6 scale (p = 0.002); the intraoperative difference did not reach significance (p = 0.085). No flap slips or microstriae. Off-label on timing, since the labeled regimen is postoperative only; small single-surgeon study.

Dougherty PJ. Acular LS before and during LASIK for the control of pain: a randomized, masked contralateral eye trial. J Refract Surg. 2009;25(2):210-3.

Contraindications

Hypersensitivity to any component of the formulation.

Available Forms

0.4% (4 mg/mL) solution, 5 mL fill in a 10 mL dropper bottle

Mechanism of Action

Nonsteroidal anti-inflammatory drug of the pyrrolo-pyrrole class; inhibits prostaglandin biosynthesis by blocking cyclooxygenase. Suppressing prostaglandin production at the ablated corneal surface reduces the pain and burning or stinging that follow refractive surgery.

Warnings & Precautions

Delayed healing: Topical NSAIDs may slow or delay healing; concomitant topical steroids compound the risk.
Cross-sensitivity: Potential cross-reactivity with acetylsalicylic acid, phenylacetic acid derivatives, and other NSAIDs. Bronchospasm and exacerbation of asthma have been reported in patients with aspirin or NSAID hypersensitivity or a past history of asthma.
Increased bleeding time: Interference with thrombocyte aggregation. Ocularly applied NSAIDs have been reported to increase bleeding of ocular tissues, including hyphema, in conjunction with surgery. Use caution with known bleeding tendencies or concomitant drugs that prolong bleeding time.
Corneal effects: Keratitis can occur, and continued use in susceptible patients may progress to epithelial breakdown, corneal thinning, erosion, ulceration, or perforation, which may be sight threatening. Discontinue immediately on corneal epithelial breakdown and monitor corneal health closely.
Higher-risk corneas: Complicated or repeat ocular surgery, corneal denervation, corneal epithelial defects, diabetes mellitus, ocular surface disease such as dry eye, and rheumatoid arthritis raise the risk of sight-threatening corneal events.
Extended perioperative use: Dosing more than 1 day before surgery or beyond 14 days after surgery increases the occurrence and severity of corneal adverse events.
Contact lens wear: Not to be administered while wearing contact lenses.
Contamination risk: Bottle tip contact with the eye or surrounding structures can contaminate the solution and cause serious ocular infection and vision loss.

Common Side Effects

Ocular, 1% to 5%: Conjunctival hyperemia, corneal infiltrates, ocular edema, ocular pain.
Ocular, most frequent: Transient stinging and burning on instillation, reported by up to 40% of patients across ketorolac ophthalmic trials.
Ocular, 1% to 10% class-wide: Allergic reactions including eye swelling, eyelid edema, and hyperemia; corneal edema; iritis; ocular inflammation; ocular irritation; superficial keratitis; superficial ocular infections.
Ocular, rare: Corneal ulcer, eye dryness, blurred vision.
Ocular, postmarketing: Corneal erosion, corneal thinning, corneal melt, corneal perforation, epithelial breakdown.
Systemic: Headache in 1% to 5%; bronchospasm or exacerbation of asthma reported postmarketing.

Pregnancy & Lactation

Pregnancy: No adequate or well-controlled studies in pregnant women; no teratogenicity seen in rats or rabbits at clinically relevant doses.

Lactation: Presence in human milk after topical dosing is unknown; use caution in a nursing woman.

Pediatric Use

Safety and effectiveness not established below age 3.