EDTA Sterile Ophthalmic Solution

 

Edetate disodium EDTAenlarge 25x30

 

Edge Pharma offers Edetate Disodium (EDTA) 1.5% and 3% sterile solution for topical ophthalmology use. As an FDA registered 503B Outsourcing facility Edge is able to produce EDTA non-patient specific (i.e. no patient names required to order). In addition, room temperature storage and extended BUD make this a simple option logistically for hospitals and surgery centers.

 

Edetate Disodium (EDTA) Drops

Sterile ophthalmic solution (PF). Singe dose droptainer for topical ophthalmic use.

  • Concentration = 1.5% or 3%
  • Single dose droptainer volume = 10 mL
  • Storage: room temperature

 

Literature Review

 

Band keratopathy is a disorder affecting the eye, characterized by calcium deposits across the cornea. Symptoms of the disorder can include blurred vision, a sensation of sand in the eye, redness, and irritation. The causes of the disease include conditions that increase calcium levels, such as lupus, kidney disease, Paget’s disease, excessive Vitamin D, and sarcoidosis.(1) Chronic ocular diseases can also lead to band keratopathy. These include: uveitis in children, interstitial keratitis, and phthisis bulbi.(2)

The signs of band keratopathy are “interpalpebral deposition of calcium phosphate salts in the subepithelial and anterior stroma with clear areas separating it from the limbus.” There are also clear areas where nerve endings perforate the Bowman’s layer with the band.(3)

“Previous generations used mechanical debridement to remove superficial calcium deposition for the cornea. The most current method involves the use of a metal ion chelator known as ethylene-diamine-tetra-acetic acid (EDTA). Studies have reported EDTA chelation to be a safe reliable method of removing band keratopathy, resulting in improvements in visual acuity and ocular comfort.”(4)

A study published in American Journal of Ophthalmology involved 54 patients (65 eyes) who underwent EDTA chelation for the treatment of band keratopathy. Outcome was measured by relief of symptoms, vision improvement, and recurrence. Partial or complete symptomatic relief was reported in 98 percent of the patients. In addition, “Seventeen eyes (33.3 percent) improved two or more lines at one month and 18 eyes (35.2 percent) at last follow-up visit. In patients with an initial visual acuity between 20/50 and 20/400, 15 eyes (47 percent) improved two or more lines at one month and 16 eyes (50 percent) at last follow-up visit.” The study concluded chelation with EDTA is an effective treatment of calcific band keratopathy, which can be used as an initial surgical intervention after conservative methods fail.(5)

 


(1) Bedinghaus, Troy OD, reviewed by Fogoros, Richard N., MD, verywell health, online article, Band Keratopathy: Symptoms and Treatment https://www.verywellhealth.com/

(2) Roy, F.H., Fraunfelder, F.T., American Academy of Ophthalmology, online article, Calcific Band Keratopathy https://www.aao.org/

(3) Columbia University Department of Ophthalmology, online article, Band Keratopathy https://www.columbiaeye.org/

(4) Al-Hity, A., Ramaesh, K, Lockington, D, U.S. National Library of Medicine, National Center for Biotechnology Information, online article, EDTA Chelation for Symptomatic Band Keratopathy: Results and Recurrencehttps://www.nature.com/

(5) Najjar, D.M., Cohen, E.J., Rapuano, C.J., Laibson, P.R., Journal of Ophthalmology, online article, EDTA Chelation for Calcific Band Keratopathy: Results and Long-term Follow-up https://www.sciencedirect.com/

 

References 

1) "EDTA Chelation Provides Solution for Band Keratopathy." Ophthalmology Times October, 15, 2005. https://www.ophthalmologytimes.com/

"Ethylene diamine tetra-acetic acid (EDTA) chelation offers a low-tech, low-cost, effective treatment for calcific band keratopathy associated with chronic uveitis and other disorders, said James P. Dunn, MD, at the Current Concepts in Ophthalmology meeting, sponsored by Johns Hopkins University School of Medicine and Ophthalmology Times."

2) P. David Freeman, Malik Y. Kahook. Expert Rev Ophthalmol. 2009;4(1):59-64 "Preservatives in Topical Ophthalmic Medications."  Medscapehttps://www.medscape.com/

"EDTA has gained use in ophthalmic solutions owing to its ability to bind metals. Therapeutically, EDTA has been used to remove calcified plaques that occur in the superficial cornea in band keratopathy. EDTA has also been used in eye washes to aid in neutralization of calcium hydroxide or lime burns to the cornea." 

 

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