Generic Name
5-Phosphate
Brand Names
EPIOXA Cross-linking, Photrexa Cross-linking
FDA approval date: September 25, 2017
Form: Kit
What is EPIOXA Cross-linking (5-Phosphate)?
PHOTREXA ® VISCOUS and PHOTREXA ® are indicated for use in corneal collagen cross-linking in combination with the KXL ® System for the treatment of PHOTREXA VISCOUS and PHOTREXA are photoenhancers indicated for use with the KXL System in corneal collagen cross-linking for the treatment of progressive keratoconus.
Approved To Treat
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Brand Information
EPIOXA CROSS-LINKING (riboflavin 5-phosphate ophthalmic)
1INDICATIONS 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
2ADVERSE REACTIONS
The following clinically significant adverse reactions are described elsewhere in the labeling:
Herpetic keratitis
2.1Clinical 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 trials. Study eyes were randomized in a 2:1 treatment allocation to receive corneal collagen cross-linking (CXL) or sham procedure/vehicle control at the baseline visit. In both trials, CXL-treated eyes were followed for 12 months.
Safety data were obtained from a total of 389 CXL-treated eyes.
The most commonly reported adverse reaction in CXL-treated eyes was conjunctival hyperaemia (31%). Other adverse reactions occurring in 5% to 25% of CXL-treated eyes included: corneal opacity (haze), photophobia, punctate keratitis, eye pain, eye irritation, lacrimation increased, corneal epithelium defect, eyelid oedema, corneal striae, visual acuity reduced, dry eye, and anterior chamber flare.
3DESCRIPTION
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 mg of riboflavin 5'-phosphate sodium (equivalent to 1.46 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 sodium chloride, dibasic sodium phosphate dihydrate, tromethamine, monobasic sodium phosphate dihydrate, and water for injection. Sodium hydroxide and/or hydrochloric acid may be added to adjust pH.
The molecular formula for riboflavin 5'-phosphate sodium (Vitamin B2) is C
4CLINICAL STUDIES
Two prospective, randomized, parallel-group, sham procedure/vehicle-controlled trials (Study 1 [NCT03442751] and Study 2 [NCT05759559]) were conducted to evaluate the safety and efficacy of epithelium-on corneal collagen cross-linking (CXL) using riboflavin 5'-phosphate ophthalmic solutions with UV-A irradiation and supplemental oxygen in patients with keratoconus.
In both trials, eligible eyes were randomized to receive CXL treatment or sham procedure/vehicle control in a 2:1 treatment allocation at the baseline visit. Aphakic patients and pseudophakic patients without a UV-blocking intraocular lens were excluded. Both eyes of a patient could be enrolled in the trial; however, one eye was treated first, and the second eye was treated between 1 week and 3 months after the first eye. Eyes were evaluated at 1 day, 3 days, 1 week, and 1, 3, 6, and 12 months post-treatment.
In Study 1, eyes randomized to sham procedure/vehicle control were permitted to receive CXL treatment after month 6 and were followed an additional 6 months. The primary efficacy endpoint was at month 6 post-treatment and the secondary efficacy endpoint was at month 12 post-treatment. In Study 2, the primary efficacy endpoint was at month 12 post-treatment and the secondary efficacy endpoint was at month 6 post-treatment.
In Study 1, a total of 280 eyes of 201 patients were randomized into the trial, of which 279 eyes were treated: 189 eyes received CXL treatment and 90 eyes initially received sham procedure/vehicle control. A statistically significant treatment effect was demonstrated at month 6, based on the difference in change from baseline in maximum corneal curvature (K
In a subgroup analysis of patients in this trial at month 6, younger patients (< 29 years) experienced a treatment effect of -2.0 D, as a combination of improvement in the CXL treatment arm (-0.7 D) and deterioration in the sham procedure/vehicle control arm (1.3 D). Older patients (≥ 29 years) did not experience improvement at month 6 in either arm.
In Study 2, a total of 312 eyes of 208 patients were randomized into the trial, of which 312 eyes were treated: 200 eyes received CXL treatment and 112 eyes received sham procedure/vehicle control. A statistically significant treatment effect was demonstrated at month 12, based on the difference in change from baseline in K
In a subgroup analysis of patients in this trial at month 12, younger patients (< 30 years) experienced a treatment effect of -1.1 D, as a combination of improvement in the CXL treatment arm (-0.5 D) and deterioration in the sham procedure/vehicle control arm (0.5 D). Older patients (≥ 30 years) in the CXL treatment arm experienced comparable improvement (-0.6 D) as younger patients (-0.5 D); however, in the sham procedure/vehicle control arm, older patients (-0.0 D) did not deteriorate as much as younger patients (0.5 D).
5HOW SUPPLIED/STORAGE AND HANDLING
EPIOXA HD (riboflavin 5'-phosphate ophthalmic solution) 0.239%, and EPIOXA (riboflavin 5'-phosphate ophthalmic solution) 0.177%, are clear, yellow, ophthalmic solutions. EPIOXA HD and EPIOXA are co-packaged in an Epithelium-on Cross-linking Kit (NDC 25357-024-01) containing:
- One single-dose glass syringe containing 2 mL of EPIOXA HD 0.239% packaged in a foil pouch.
- One single-dose glass syringe containing 2 mL of EPIOXA 0.177% packaged in a foil pouch.
6PATIENT COUNSELING INFORMATION
- Advise patients that there may be discomfort in the treated eye and that sunglasses may help with light sensitivity.
- Instruct patients that they should contact their physician immediately if they experience severe pain in the treated eye or any sudden decrease in their vision.
7PRINCIPAL DISPLAY PANEL - Kit Carton
NDC 25357-024-01
Rx Only
Epithelium-on Cross-linking Kit
Epioxa™ HD
co-packaged with
Epioxa™
For Topical Ophthalmic Use Only
Use only with O
GLAUKOS
