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Endophthalmitis Research Paper

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Endophthalmitis is a vision-threatening complication that commonly occurs after cataract surgery. Visual outcomes are often debilitating, with 50% recovering 20/40 vision and about 30% being able to count their fingers.1 Because cataract surgery is the most commonly performed ocular procedure worldwide, postoperative endophthalmitis is an important public health issue associated with significant morbidity and high medical costs. Current prevention strategies in the United States include routine operating room aseptic protocols and perioperative topical antibiotic prophylaxis.2 However, recent studies of the past decade favor intracameral antibiotic administration, which involves a bolus injection into the anterior chamber at the end of surgery, …show more content…

due to a lack of a Food and Drug Administration approved intracameral antibiotic formulation. Consequently ophthalmologists who wish to apply intracameral antibiotics to their practice have turned to compounding antibiotics. Compounding of drugs is a process of mixing pharmacological ingredients with other reagents. Antibiotics meant for intravenous use is mixed with different solutions such as saline to obtain a solution for intracameral use. However, compounding of antibiotics must be formulated by licensed pharmacies that are capable of meeting the United States Pharmacopeial Convention’s standards to prevent dilution errors, contaminations, and other complications.11 Failure to be adhere to the USP’s standards can lead to a myriad of problems. Toxic anterior segment syndrome and permanent visual loss have been reported after dosing errors of intracameral antibiotics. Overdose of intracameral cefuroxime has been associated with severe uveitis and retinal vascular leakage.12 Intracameral vancomycin, in recent news, has also been suspected to cause dose-dependent ischemic retinal vasculitis after cataract surgery. Hence, safe and USP-compliant formulation is vital in preventing postoperative complications. Proper compounding of antibiotics requires …show more content…

Many researchers question the limitations of the ESCRS study and its application to the American patient population. Another large RCT is needed to demonstrate a statistically significant reduction in postoperative endophthalmitis with the use of a U.S. commercially manufactured intraocular antibiotic. However to date, no New Drug Application for an intracameral antibiotic preparation has been submitted to the FDA. It is proposed that the lack of interested commercial sponsors is a result of the likely insignificant economic return of such drug products.15 After all, antibiotics are categorized under the Food, Drug, and Cosmetic Act. The first manufacturer to invest and create an intraocular antibiotic preparation in the U.S. would not be granted a period of market exclusivity and thus would have no legal protection against

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