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Intracameral Therapeutics for Cataract Surgery

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Intracameral Therapeutics for Cataract Surgery s THE LITERATURE INTRACAMERAL THERAPEUTICS FOR CATARACT SURGERY Closing in on no-drop surgery. BY MARK A. KONTOS, MD; AND KENDALL E. DONALDSON, MD, MS DEXAMETHASONE INTRACAMERAL ninety-four patients scheduled for Anterior chamber cell clearing at DRUG-DELIVERY SUSPENSION FOR cataract surgery at 27 sites were day 8 was achieved in 25% of eyes INFLAMMATION ASSOCIATED WITH randomly assigned to three groups. in group 1, 63% in group 2, and CATARACT SURGERY: A RANDOMIZED, Group 1 received a 5-µL injection of 66% in group 3 (P > .001). Anterior PLACEBO-CONTROLLED PHASE III TRIAL placebo. Groups 2 and 3, respectively, chamber flare clearing at day 8 was received a 5-µL injection of 342 µg or achieved in 63.8% of eyes in group 1, Donnenfeld E, Holland E1 517 µg dexamethasone drug delivery 92.4% in group 2, and 89.1% in group suspension into the anterior chamber 3 (P > .001). Adverse events were ABSTRACT SUMMARY at the conclusion of cataract surgery. similar among the three groups with In this randomized, double-masked, Patients were observed for 90 days no serious adverse events reported up placebo-controlled study, inves- after surgery. to postoperative day 90. tigators sought to determine the The primary outcome measure safety and efficacy of dexamethasone was anterior chamber cell clearing DISCUSSION intraocular suspension 9% (Dexycu, at postoperative day 8. Secondary The appropriate postoperative EyePoint Pharmaceuticals) for measures were anterior chamber flare medical regimen for cataract surgery intracameral administration in and anterior chamber cell plus flare remains a hotly debated subject. The two dosages in patients undergoing clearing in the study eyes. Adverse use of topical steroids alone and in cataract surgery. Three hundred events were also assessed. combination continues to be the mainstay of managing inflammation and pain after surgery.2,3 Currently the only FDA-approved topical corticosteroids for postoperative STUDY IN BRIEF inflammation are difluprednate and rimexolone,4,5 but topical dexametha- s A phase 3 clinical trial was designed to determine the safety and efficacy of a novel sone and prednisolone acetate are formulation of intracameral dexamethasone for the treatment of inflammation after commonly used off-label.6 cataract surgery. This large multicenter randomized controlled study found that a Many issues make topical therapy slow-release delivery system of the drug was a safe and effective alternative to topical problematic for the treatment steroid therapy after cataract surgery. of inflammation after cataract surgery. Poor compliance is a major WHY IT MATTERS issue. Many patients are unable to The possibility of administering a single dose of a steroid at the time of cataract surgery administer drops in a consistent manner, making it difficult to know and eliminating postoperative eye drops could offer significant advantages to both surgeons 7 and patients. Based on this study’s results, a slow-release delivery system of dexamethasone what is actually reaching the eye. The high cost of medications is may help make that possibility a reality. Direct comparisons of this system and other forms of another obstacle to proper dosing for treatment are needed. some patients. Additionally, adverse events such as IOP spikes and allergic 18 CATARACT & REFRACTIVE SURGERY TODAY | JULY 2019 THE LITERATURE s reactions make topical therapy through surface tension in the at all endpoints. It was also noted less than ideal for the treatment anterior chamber and slowly releases that these patients showed better of postoperative inflammation. dexamethasone over a 21-day clearing of the anterior chamber at Eliminating the need for eye drops period. Concentrations are highest day 8 than is commonly observed after cataract surgery could thus offer on day 1 and steadily decrease with current topical steroid many advantages. thereafter. Patients receiving therapies.8 In addition to meeting This study found that intracameral intracameral dexamethasone showed efficacy endpoints, intracameral delivery of dexamethasone in a significantly greater clearing of cell dexamethasone was shown to be slow-release form can be an effective and flare of the anterior chamber safe, with no significant adverse alternative to topical therapy. The compared to the placebo group. This events noted during the 90-day injected 5-µL droplet forms a sphere difference was statistically significant period of observation. SAFETY AND EFFICACY OF INTRACAMERAL MOXIFLOXACIN FOR PREVENTION OF POST-CATARACT STUDY IN BRIEF ENDOPHTHALMITIS: RANDOMIZED CONTROLLED CLINICAL TRIAL s This is the first large prospective randomized controlled clinical trial to evaluate the safety and efficacy of intracameral moxifloxacin for the postoperative prevention of Melega MV, Alves M, Cavalcanti Lira RP, endophthalmitis associated with cataract surgery. et al9 WHY IT MATTERS ABSTRACT SUMMARY Intracameral antibiotics appear to be a safe and effective means of protecting patients from This controlled, randomized, the rare incidence of infection that may be associated with cataract surgery. single-center (including three hospitals associated with the University of Campinas in São Paulo, Brazil) clinical trial comprised 3,640 eyes of overwhelming efficacy of intracameral an eye in rare instances.14-16 Limited 3,640 patients undergoing cataract antibiotics, this practice has gained availability of intracameral antibiotics surgery. Patients were randomly widespread attention.10-13 The globally has prompted many surgeons assigned to one of two groups: one ESCRS investigators reported a to prepare drugs in the OR, which group received an intracameral fivefold decrease in the incidence has led to errors that have resulted injection of 0.03 mL (150 µg) of of endophthalmitis associated with in clinical manifestations such as undiluted moxifloxacin at the end of intracameral cefuroxime, resulting macular edema, retinal vascular surgery, and the other received no in the commercial manufacture of a leakage, uveitis, endothelial toxicity, intracameral injection. All patients single-use preparation of this agent toxic anterior segment syndrome, and received postoperative antibiotic and labeled for intraocular use (Aprokam, infection.14-16 antiinflammatory drops (0.5% moxi- Laboratoires Théa) that quickly Moxifloxacin is a fourth-generation floxacin and 0.1% dexamethasone). became available for use in Europe and fluoroquinolone that provides Patients were observed for a period elsewhere in the world but not in the broad-spectrum coverage against of 6 weeks postoperatively. During this United States.10 gram-positive bacteria, gram-negative time, the incidence of endophthalmitis This country has faced challenges bacteria, atypical microorganisms, was 0.05% (1:1,818 eyes) in the moxi- related to implementation of such and anaerobes. Concern is rising floxacin group and 0.38% (7:1,822 eyes) a regimen, including issues related about increasing drug resistance, in the control group (P = .202). No to the safety of compounding however, because of moxifloxacin’s side effects related to intracameral medications for intraocular use.14-16 popularity.17 The agent has been moxifloxacin were observed during There have been documented cases used off-label for the prevention of the study. of compounding errors, including endophthalmitis for many years, but dilutional mistakes, pH imbalance, only recently has attention begun to DISCUSSION contamination, and other deviations focus on conducting controlled trials Since the 2007 publication of that have led to profound vision loss to better elucidate the drug’s efficacy ESCRS study results indicating an in some patients and even loss of for endophthalmitis prophylaxis. JULY 2019 | CATARACT & REFRACTIVE SURGERY TODAY 19 s THE LITERATURE 10. Endophthalmitis Study Group, European Society of Cataract & Refractive KENDALL E. DONALDSON, MD, MS As cataract surgery evolves and Surgeons. Prophylaxis of postoperative endophthalmitis following cataract interest in bilateral, same-day, surgery: results of the ESCRS multicenter study and identification of risk factors. n Professor of Clinical Ophthalmology, J Cataract Refract Surg. 2007;33(6):978-988. office-based, no-drop surgery grows, 11. Gower EW, Lindsley K, Tulenko SE, et al. Perioperative antibiotics for Cornea/external disease/refractive surgeon, and intracameral antibiotics may eventu- prevention of acute endophthalmitis after cataract surgery. Cochrane Database Medical Director, Bascom Palmer Eye Institute, Syst Rev. 2017;2:CD006364. ally become a necessity. In the United 12. Kessel L, Flesner P, Andresen J, et al. Antibiotic prevention of postcataract Plantation, Florida endophthalmitis: a systematic review and meta-analysis. Acta Ophthalmol. n Member, CRST Editorial Advisory Board States, the controlled delivery and 2015;93(4):303-317. manufacturing of these medications 13. Bowen RC, Zhou AX, Bondalapati S, et al. Comparative analysis of the safety n [email protected] and efficacy of intracameral cefuroxime, moxifloxacin and vancomycin at the n are being fine-tuned. n end of cataract surgery: a meta-analysis. Br J Ophthalmol. 2018;102(9):1268- Financial disclosure: Consultant 1276. (Alcon, Allergan, Bausch + Lomb, Bio-Tissue, 1. Donnenfeld E, Holland E. Dexamethasone intracameral drug-delivery 14. Olavi P. Ocular toxicity in cataract surgery because of inaccurate preparation Carl Zeiss Meditec, Eyevance Pharmaceuticals, suspension for inflammation associated with cataract surgery: a randomized, and erroneous
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