Epioxa Cross-Linking

What is Epioxa Cross-Linking?

11 DESCRIPTION EPIOXA HD (riboflavin 5'-phosphate ophthalmic solution) 0.239% and EPIOXA (riboflavin 5'-phosphate ophthalmic solution) 0.177% contain riboflavin 5'-phosphate, a photoenhancer, for topical ophthalmic use. EPIOXA HD 0.239% is a clear, yellow, sterile buffered solution containing 2.39 mg/mL riboflavin 5'-phosphate. The pH of the solution is 6.7 to 7.7 and the osmolality is 200 mOsm/kg to 260 mOsm/kg. Each mL of solution contains 2.50 mg of riboflavin 5'-phosphate sodium (equivalent to 1.97 mg/mL riboflavin). Riboflavin 5'-phosphate sodium is a mixture of the sodium salts of riboflavin, riboflavin monophosphates, and riboflavin diphosphates. The inactive ingredients are hydroxypropyl methylcellulose, sodium chloride, dibasic sodium phosphate dihydrate, edetate disodium dihydrate, tromethamine, monobasic sodium phosphate dihydrate, benzalkonium chloride, and water for injection. Sodium hydroxide and/or hydrochloric acid may be added to adjust pH. EPIOXA 0.177% is a clear, yellow, sterile buffered solution containing 1.77 mg/mL riboflavin 5'-phosphate. The pH of the solution is 6.5 to 7.5 and the osmolality is 330 mOsm/kg to 400 mOsm/kg. Each mL of solution contains 1.85

Uses of Epioxa Cross-Linking

Established uses

• 1 INDICATIONS AND USAGE EPIOXA HD and EPIOXA are indicated in epithelium-on corneal collagen cross-linking for the treatment of keratoconus in adults and pediatric patients aged 13 years and older, in conjunction with the O 2 n System and the Boost Goggles.
• EPIOXA HD and EPIOXA are photoenhancers indicated for use in epithelium-on corneal collagen cross-linking for the treatment of keratoconus in adults and pediatric patients aged 13 years and older, in conjunction with the O 2 n System and the Boost Goggles ( 1 ).

How Epioxa Cross-Linking works

In more detail: 12.1 Mechanism of Action Riboflavin 5'-phosphate sodium (Vitamin B2) is the precursor of two coenzymes, flavin adenine dinucleotide and flavin mononucleotide, which catalyze oxidation/reduction reactions involved in a number of metabolic pathways. Under the conditions used for corneal collagen cross-linking, riboflavin 5'-phosphate functions as a photoenhancer and generates singlet oxygen which is responsible for the cross-linking.

How to take Epioxa Cross-Linking

2 DOSAGE AND ADMINISTRATION Apply topical anesthetic and insert a lid speculum ( 2 ). Using a cellulose spear sponge soaked with EPIOXA HD, remove the mucin layer from the corneal surface without debriding the corneal epithelium (epithelium-on) by swiping the sponge 4 to 10 times horizontally and vertically ( 2 ). Apply two drops of EPIOXA HD topically on the eye every 60 seconds for 4 minutes (STEP 1), followed by two drops of EPIOXA topically on the eye every 30 seconds for 6 minutes (STEP 2) ( 2 ). Gently rinse the corneal surface with approximately 5 mL of balanced salt solution (BSS) ( 2 ). Perform ultrasound pachymetry. If corneal thickness is less than 325 microns, irradiation should not be performed ( 2 ). Apply the Boost Goggles and turn on the oxygen flow. Refer to the Boost Goggles User Guide ( 2 ). Center the optical head of the O 2 n System over the cornea and irradiate the eye as per the instructions in the O 2 n System Operator's Manual . The O 2 n System automatically delivers irradiation to the eye for 11 minutes 6 seconds at 30 mW/cm 2 with an on/off cycle of 1 second UV-A on/ 1 second UV-A off at a wavelength of 365 nm ( 2 ). Instill BSS on the cornea every 2 min

Dosage

Follow the dose prescribed by your doctor or pharmacist. The ranges below are general information, not a personal prescription.

Adults

2 DOSAGE AND ADMINISTRATION Apply topical anesthetic and insert a lid speculum ( 2 ). Using a cellulose spear sponge soaked with EPIOXA HD, remove the mucin layer from the corneal surface without debriding the corneal epithelium (epithelium-on) by swiping the sponge 4 to 10 times horizontally and vertically ( 2 ). Apply two drops of EPIOXA HD topically on the eye every 60 seconds for 4 minutes (STEP 1), followed by two drops of EPIOXA topically on the eye every 30 seconds for 6 minutes (STEP 2) ( 2 ). Gently rinse the corneal surface with approximately 5 mL of balanced salt solution (BSS) ( 2 ). Perform ultrasound pachymetry. If corneal thickness is less than 325 microns, irradiation should not be performed ( 2 ). Apply the Boost Goggles and turn on the oxygen flow. Refer to the Boost Goggles User Guide ( 2 ). Center the optical head of the O 2 n System over the cornea and irradiate the eye as per the instructions in the O 2 n System Operator's Manual . The O 2 n System automatically delivers irradiation to the eye for 11 minutes 6 seconds at 30 mW/cm 2 with an on/off cycle of 1 second UV-A on/ 1 second UV-A off at a wavelength of 365 nm ( 2 ). Instill BSS on the cornea every 2 min

Side effects of Epioxa Cross-Linking

Common

• 6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Herpetic keratitis [see Warnings and Precautions (5.1) ] The most common adverse reaction was conjunctival hyperaemia (31%).
• Other adverse reactions, occurring in 5% to 25% of eyes included: corneal opacity (haze), photophobia, punctate keratitis, eye pain, eye irritation, increased lacrimation, corneal epithelium defect, eyelid oedema, corneal striae, visual acuity reduced, dry eye, and anterior chamber flare ( 6.1 ).
• To report SUSPECTED ADVERSE REACTIONS, contact GLAUKOS CORPORATION at 1-888-404-1644 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
• 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
• The safety of EPIOXA HD and EPIOXA in the epithelium-on corneal collagen cross-linking procedure with UV-A irradiation and supplemental oxygen was evaluated in two randomized, parallel-group, sham procedure/vehicle-controlled tria

Warnings and who should not take it

Who should NOT take Epioxa Cross-Linking?

• 4 CONTRAINDICATIONS Hypersensitivity ( 4.1 ) Aphakic and pseudophakic patients without a UV-blocking intraocular lens ( 4.2 ) 4.1 Hypersensitivity EPIOXA HD and EPIOXA are contraindicated in patients with known hypersensitivity to benzalkonium chloride or any ingredients in EPIOXA HD and EPIOXA.
• 4.2 Aphakic and Pseudophakic Patients Epithelium-on corneal collagen cross-linking is contraindicated in aphakic patients and pseudophakic patients without a UV-blocking intraocular lens.

Safety at a glance

Children and elderly

Frequently asked questions