Brand Name
Photrexa Cross-linking
Generic Name
5-Phosphate
View Brand Information FDA approval date: September 25, 2017
Form: Kit
What is Photrexa 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
Top Global Experts
Save this treatment for later
Not sure about your diagnosis?
Tired of the same old research?
Related Clinical Trials
Study of Pyridoxal 5'-Phosphate for the Treatment of Patients With PNPO Deficiency
Summary: The proposed clinical study is intended to evaluate oral P5P for the treatment of patients confirmed to have Pyridox(am)ine 5'-Phosphate Oxidase (PNPO) deficiency via genetic analysis. There is an unmet clinical need for pharmaceutical grade P5P, as to date none has been made commercially available. Patients will receive pharmaceutical grade P5P according to their normal oral P5P dosing regimen, a...
Testing the Potential of High-dose Vitamin B6 Supplements for Sensory Reactivity in Autism
Summary: This clinical trial aims to explore the effect of Vitamin B6 supplementation on anxiety sensory hyperreactivity in autistic adults. Researchers will compare a placebo group to high-dose Vitamin-B6 to see if vitamin B6 reduce anxiety and sensory reactivity differences in autism.
A Phase IV Observational Registry to Assess the Safety and Durability of Effect of Corneal Collagen Cross-linking With Photrexa Viscous, Photrexa, and the KXL System in Patients With Corneal Ectasia Following Refractive Surgery
Summary: The objectives of this post market registry are to evaluate the safety and durability of treatment effect up to 3 years following cross-linking performed with Photrexa Viscous (riboflavin 5'- phosphate in 20% dextran ophthalmic solution), Photrexa (riboflavin 5'- phosphate ophthalmic solution), and the KXL System in patients with corneal ectasia following refractive surgery.
Related Latest Advances
Brand Information
Photrexa Cross-linking Kit (riboflavin 5-phosphate ophthalmic)
1INDICATIONS AND USAGE
PHOTREXA
2DOSAGE AND ADMINISTRATION
Using topical anesthesia, debride the epithelium to a diameter of approximately 9 mm using standard aseptic technique. Post epithelial debridement, instill 1 drop of PHOTREXA VISCOUS topically on the eye every 2 minutes for 30 minutes.
At the end of the 30 minute soaking period, examine the eye under the slit lamp for the presence of a yellow flare in the anterior chamber. If the yellow flare is not detected, instill 1 drop of PHOTREXA VISCOUS every 2 minutes for an additional 2 to 3 drops and recheck for the presence of a yellow flare. This process can be repeated as necessary.
Once the yellow flare is observed, perform ultrasound pachymetry. If corneal thickness is less than 400 microns, instill 2 drops of PHOTREXA every 5 to 10 seconds until the corneal thickness increases to at least 400 microns. Irradiation should not be performed unless this 400 micron threshold is met and the yellow flare is seen.
Irradiate the eye for 30 continuous minutes at 3mW/cm
For topical ophthalmic use. Do not inject.
Single use PHOTREXA VISCOUS and PHOTREXA only. Discard syringe(s) after use.
PHOTREXA VISCOUS and PHOTREXA are for use with the KXL System only.
PLEASE REFER TO THE KXL OPERATOR’S MANUAL FOR SPECIFIC DEVICE INSTRUCTIONS.
3CONTRAINDICATIONS
None.
4WARNINGS AND PRECAUTIONS
Ulcerative keratitis can occur. Monitor for resolution of epithelial defects.
5ADVERSE REACTIONS
The following clinically significant adverse reactions are described elsewhere in the labeling:
Ulcerative keratitis
5.1Clinical 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 the corneal collagen cross-linking procedure was evaluated in 3 randomized, parallel-group, open-label, sham-controlled trials; patients were followed up for 12 months. Study 1 enrolled patients with progressive keratoconus or corneal ectasia following refractive surgery. Study 2 enrolled only patients with progressive keratoconus, and Study 3 enrolled only patients with corneal ectasia following refractive surgery. In each study, only one eye of each patient was designated as the study eye. Study eyes were randomized to receive one of the two study treatments (CXL or sham) at the baseline visit and were followed up at Day 1, Week 1, and Months 1, 3, 6, and 12. At Month 3 or later, sham study eyes and non-study eyes had the option of receiving CXL treatment, and were followed-up for 12 months from the time of receiving CXL treatment. Each CXL treated eye received a single course of CXL treatment only.
Safety data were obtained from: 193 randomized CXL study eyes (102 keratoconus, 91 corneal ectasia), 191 control eyes, and 319 nonrandomized CXL non-study eyes (191 keratoconus, 128 corneal ectasia). Overall, 512 eyes (293 keratoconus, 219 corneal ectasia) in 364 patients received CXL treatment.
In progressive keratoconus patients, the most common ocular adverse reactions in any CXL-treated eye were corneal opacity (haze), punctate keratitis, corneal striae, corneal epithelium defect, eye pain, reduced visual acuity, and blurred vision (
In corneal ectasia patients, the most common ocular adverse reactions were corneal opacity (haze), corneal epithelium defect, corneal striae, dry eye, eye pain, punctate keratitis, photophobia, reduced visual acuity, and blurred vision. These events are expected sequelae following epithelial corneal debridement and occurred at a higher incidence than observed in control patients, who did not undergo debridement or exposure to UVA light (
Adverse events reported in non-study, non-randomized CXL treated were similar in terms of preferred terms and frequency to those seen in randomized study eyes.
The majority of adverse events reported resolved during the first month, while events such as corneal epithelium defect, corneal striae, punctate keratitis, photophobia, dry eye and eye pain, and decreased visual acuity took up to 6 months to resolve and corneal opacity or haze took up to 12 months to resolve. In 1-2% of patients, corneal epithelium defect, corneal edema, corneal opacity and corneal scar continued to be observed at 12 months. In 6% of corneal ectasia patients, corneal opacity continued to be observed at 12 months.
Headache was reported in between 4 to 8% of treated patients.
6DESCRIPTION
PHOTREXA VISCOUS (riboflavin 5’-phosphate in 20% dextran ophthalmic solution) 0.146% and PHOTREXA (riboflavin 5’-phosphate ophthalmic solution) 0.146% are intended for topical ophthalmic administration as part of corneal collagen cross-linking with the KXL System.
PHOTREXA VISCOUS and PHOTREXA are supplied as:
- PHOTREXA VISCOUS in a 3 mL glass syringe containing sterile 1.56 mg/mL riboflavin 5’-phosphate in 20% dextran ophthalmic solution for topical administration.
- PHOTREXA in a 3 mL glass syringe containing sterile 1.46 mg/mL riboflavin 5’-phosphate ophthalmic solution for topical administration.
PHOTREXA VISCOUS (riboflavin 5’-phosphate in 20% dextran ophthalmic solution) 0.146% is a yellow sterile buffered viscous solution containing 1.56 mg/mL riboflavin 5’-phosphate and 20% dextran . The pH of the solution is approximately 7.1 and the osmolality is 284-368 mOsm/kg. Each 1 mL of solution contains 1.64 mg of riboflavin 5’-phosphate sodium (equivalent to 1.284 mg riboflavin). Riboflavin 5’-phosphate sodium is a mixture of the sodium salts of riboflavin, riboflavin monophosphates, and riboflavin diphosphates. The inactive ingredients are dibasic sodium phosphate dihydrate, dextran, monobasic sodium phosphate dihydrate, sodium chloride, and water for injection. Sodium hydroxide and/or hydrochloric acid may be added to adjust pH.
PHOTREXA (riboflavin 5’-phosphate ophthalmic solution) 0.146% is a yellow sterile buffered solution containing 1.46 mg/mL riboflavin 5’-phosphate. The pH of the solution is approximately 7.1 and the osmolality is 157-181 mOsm/kg. Each 1 mL of solution contains 1.53 mg of riboflavin 5’-phosphate sodium (equivalent to 1.20 mg riboflavin). Riboflavin 5’-phosphate sodium is a mixture of the sodium salts of riboflavin, riboflavin monophosphates, and riboflavin diphosphates. The inactive ingredients are dibasic sodium phosphate dihydrate, monobasic sodium phosphate dihydrate, sodium chloride, and water for injection. Sodium hydroxide and/or hydrochloric acid may be added to adjust pH.
The chemical formula for riboflavin 5’-phosphate sodium (Vitamin B2) is C
Please refer to the KXL System Operator’s Manual for a specific device description and instructions.
7CLINICAL STUDIES
Three prospective, randomized, parallel-group, open-label, sham-controlled trials were conducted to evaluate the safety and effectiveness of riboflavin ophthalmic solution/UVA irradiation for performing corneal collagen cross-linking. These trials were sham-controlled for the first 3 months and had a total duration of 12 months for safety and efficacy evaluations. Study 1 enrolled 58 patients with progressive keratoconus and 49 patients with corneal ectasia following refractive surgery. Study 2 enrolled 147 patients with progressive keratoconus, and Study 3 enrolled 130 patients with corneal ectasia following refractive surgery. In each study, patients had one eye designated as the study eye and were randomized to receive one of two study treatments (CXL or sham) in their study eye at the baseline visit. The patients were evaluated at Day 1, Week 1, and Months 1, 3, 6, and 12. At Month 3 or later, patients had the option of receiving CXL treatment in both the sham study eyes and non-study eyes and were followed-up for 12 months from the time of receiving CXL treatment.
Approximately 56% and 89% of the sham study eyes in patients with progressive keratoconus received CXL treatment by Month 3 and Month 6, respectively. The average age of keratoconus patients was 33 years. The average baseline K
In each study, the maximum corneal curvature (K
For corneal ectasia patients, at Month 12, the CXL-treated eyes had an average K
Figure 1: Mean (SD) (Diopter) Baseline Kmax and Change from Baseline Kmax
Post-baseline missing data were imputed using last available K
8HOW SUPPLIED/STORAGE AND HANDLING
PHOTREXA
Single-use foil pouches of PHOTREXA
Each foil pouch contains a 3 mL glass syringe of PHOTREXA
Kits should be stored at 2°C to 8°C (36°F to 46°F). Care should be taken to minimize exposure of the syringe to light once removed from its protective packaging. Discard syringe after use.
For topical ophthalmic use.
PHOTREXA
9PATIENT COUNSELING INFORMATION
- Patients should be advised not to rub their eyes for the first five days after their procedure.
- Patients may be sensitive to light and have a foreign body sensation. Patients should be advised that there may be discomfort in the treated eye and that sunglasses may help with light sensitivity.
- If patients experience severe pain in the eye or any sudden decrease in their vision, they should be advised to contact their physician immediately.
- If the bandage contact lens that was placed on the patient’s eye on the day of treatment falls out or becomes dislodged, the patient should be advised not to replace it and to contact their physician immediately.
PHOTREXA
Version:
ML-00043 REV3
10PRINCIPAL DISPLAY PANEL - Photrexa Viscous Syringe Label
11PRINCIPAL DISPLAY PANEL - Photrexa Viscous Foil Pouch Label
12PRINCIPAL DISPLAY PANEL - Photrexa Viscous Tyvek Pouch Label
13PRINCIPAL DISPLAY PANEL - Photrexa Syringe Label
14PRINCIPAL DISPLAY PANEL - Photrexa Foil Pouch Label
15PRINCIPAL DISPLAY PANEL - Photrexa Tyvek Pouch Label
16PRINCIPAL DISPLAY PANEL - NDC 25357-025-03 - Photrexa/Photrexa Viscous Single Treatment Kit Label
