warnings and cautions
5 WARNINGS AND PRECAUTIONS Ulcerative keratitis can occur. Monitor for resolution of epithelial defects. [See Adverse Reactions (6) ] . Ulcerative keratitis can occur. Monitor for resolution of epithelial defects ( 5 )
Photrexa Cross-linking Kit
openFDA label record#
This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.
Verified complete openFDA source JSON
- Brand name
- Photrexa Cross-linking Kit
- Generic name
- RIBOFLAVIN 5-PHOSPHATE OPHTHALMIC
- Manufacturer
- Glaukos Corporation
- Product type
- HUMAN PRESCRIPTION DRUG
- SPL set ID
- f82cfe92-1a24-11e3-8ffd-0800200c9a66
- SPL ID
- c945d9a7-2e14-41c7-a209-e537aba21749
- Version
- 26
- Effective date
- 2026-07-24
- Source export date
- 2026-09-28
- Source partition
- 1
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0001-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-09-28/9c7783846d422acb0c9e59457606951c785a7d28cc631c8cc4839d0dc7c55f39/drug-label-0001-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 05:12:29
Harmonized identifier links#
Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.
| Type | Scope | Identifier | Source field |
|---|---|---|---|
| application applno | NDA | 203324 | derived:openfda.application_number |
| application number | NDA203324 | openfda.application_number | |
| brand name | Photrexa Cross-linking Kit | openfda.brand_name | |
| generic name | RIBOFLAVIN 5-PHOSPHATE OPHTHALMIC | openfda.generic_name | |
| manufacturer name | Glaukos Corporation | openfda.manufacturer_name | |
| ndc | package | 25357-025-03 | openfda.package_ndc |
| ndc | product | 25357-025 | openfda.product_ndc |
| ndc11 | package | 25357002503 | derived:openfda.package_ndc |
| rxcui | 1925830 | openfda.rxcui | |
| rxcui | 1925825 | openfda.rxcui | |
| spl id | c945d9a7-2e14-41c7-a209-e537aba21749 | id | |
| spl set id | f82cfe92-1a24-11e3-8ffd-0800200c9a66 | set_id |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Ulcerative keratitis [ Warnings and Precautions (Section 5) ] 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 ( 6.1 ). 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 ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Avedro at 1-844-528-3376 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 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 ( Table 1 ). 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 ( Table 1 ). 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. Table 1: Most Common (≥1%) Ocular Adverse Reactions in CXL-Treated Study Eye in the Pooled Randomized Safety Population – N (%) 1) Results are presented as the number (%) of patients with an event from baseline to Month 3. 2) Almost all cases of corneal opacity were reported as haze. Progressive Keratoconus Studies Corneal Ectasia Studies Preferred Term CXL Group (N=102) 1 Control Group (N=103) 1 CXL Group (N=91) 1 Control Group (N=88) 1 Anterior chamber cell 2 (2) 0 2 (2) 1 (1) Anterior chamber flare 4 (4) 0 5 (6) 2 (2) Asthenopia 1 (1) 1 (1) 2 (2) 0 Blepharitis 0 0 0 1 (1) Corneal disorder 3 (3) 1 (1) 3 (3) 0 Corneal epithelium defect 24 (24) 1 (1) 26 (28) 3 (3) Corneal oedema 3 (3) 0 3 (3) 0 Corneal opacity 2 65 (64) 9 (9) 65 (71) 8 (9) Corneal striae 24 (24) 12 (12) 8 (9) 6 (7) Corneal thinning 1 (1) 2 (2) 0 0 Diplopia 2 (2) 1 (1) 1 (1) 0 Dry eye 6 (6) 2 (2) 13 (14) 4 (5) Eye complication associated with device 2 (2) 0 1 (1) 0 Eye discharge 2 (2) 1 (1) 0 0 Eye oedema 7 (7) 0 0 0 Eye pain 17 (17) 3 (3) 24 (26) 0 Eye pruritus 2 (2) 0 0 0 Eyelid oedema 5 (5) 0 5 (6) 1 (1) Foreign body sensation in eyes 15 (15) 1 (1) 13 (14) 2 (2) Glare 4 (4) 1 (1) 2 (2) 0 Halo vision 1 (1) 0 2 (2) 0 Keratitis 1 (1) 0 3 (3) 0 Lacrimation increased 5 (5) 0 9 (10) 1 (1) Meibomian gland dysfunction 1 (1) 1 (1) 3 (3) 2 (2) Ocular discomfort 0 0 8 (9) 0 Ocular hyperaemia 14 (14) 2 (2) 7 (8) 4 (5) Photophobia 11 (11) 0 17 (19) 0 Punctate keratitis 25 (25) 8 (8) 18 (20) 3 (3) Vision blurred 16 (16) 2 (2) 15 (17) 4 (5) Visual acuity reduced 10 (10) 9 (9) 10 (11) 1 (1) Visual impairment 3 (3) 2 (2) 4 (4) 1 (1) Vitreous detachment 2 (2) 0 0 0 Headache was reported in between 4 to 8% of treated patients.
adverse reactions table
<table styleCode="Noautorules" width="700" ID="table1"><caption>Table 1: Most Common (≥1%) Ocular Adverse Reactions in CXL-Treated Study Eye in the Pooled Randomized Safety Population – N (%)</caption><col width="28%"/><col width="18%"/><col width="18%"/><col width="18%"/><col width="18%"/><tfoot><tr><td colspan="5">1) Results are presented as the number (%) of patients with an event from baseline to Month 3.</td></tr><tr><td colspan="5">2) Almost all cases of corneal opacity were reported as haze.</td></tr></tfoot><tbody><tr><td styleCode="Toprule Rrule"/><td styleCode="Toprule Botrule Lrule Rrule" colspan="2" align="center"><content styleCode="bold">Progressive Keratoconus Studies</content></td><td styleCode="Toprule Botrule Lrule" colspan="2" align="center"><content styleCode="bold">Corneal Ectasia Studies</content></td></tr><tr><td styleCode="Botrule Rrule" valign="bottom"><content styleCode="bold">Preferred Term</content></td><td styleCode="Botrule" align="center"><content styleCode="bold">CXL Group (N=102)<sup>1</sup></content></td><td styleCode="Botrule Rrule" align="center"><content styleCode="bold">Control Group (N=103)<sup>1</sup></content></td><td styleCode="Botrule" align="center"><content styleCode="bold">CXL Group (N=91)<sup>1</sup></content></td><td styleCode="Botrule" align="center"><content styleCode="bold">Control Group (N=88)<sup>1</sup></content></td></tr><tr><td styleCode="Rrule">Anterior chamber cell</td><td align="center">2 (2)</td><td align="center" styleCode="Rrule">0</td><td align="center">2 (2)</td><td align="center">1 (1)</td></tr><tr><td styleCode="Rrule">Anterior chamber flare</td><td align="center">4 (4)</td><td align="center" styleCode="Rrule">0</td><td align="center">5 (6)</td><td align="center">2 (2)</td></tr><tr><td styleCode="Rrule">Asthenopia</td><td align="center">1 (1)</td><td align="center" styleCode="Rrule">1 (1)</td><td align="center">2 (2)</td><td align="center">0</td></tr><tr><td styleCode="Rrule">Blepharitis</td><td align="center">0</td><td align="center" styleCode="Rrule">0</td><td align="center">0</td><td align="center">1 (1)</td></tr><tr><td styleCode="Rrule">Corneal disorder</td><td align="center">3 (3)</td><td align="center" styleCode="Rrule">1 (1)</td><td align="center">3 (3)</td><td align="center">0</td></tr><tr><td styleCode="Rrule">Corneal epithelium defect</td><td align="center">24 (24)</td><td align="center" styleCode="Rrule">1 (1)</td><td align="center">26 (28)</td><td align="center">3 (3)</td></tr><tr><td styleCode="Rrule">Corneal oedema</td><td align="center">3 (3)</td><td align="center" styleCode="Rrule">0</td><td align="center">3 (3)</td><td align="center">0</td></tr><tr><td styleCode="Rrule">Corneal opacity<sup>2</sup></td><td align="center">65 (64)</td><td align="center" styleCode="Rrule">9 (9)</td><td align="center">65 (71)</td><td align="center">8 (9)</td></tr><tr><td styleCode="Rrule">Corneal striae</td><td align="center">24 (24)</td><td align="center" styleCode="Rrule">12 (12)</td><td align="center">8 (9)</td><td align="center">6 (7)</td></tr><tr><td styleCode="Rrule">Corneal thinning</td><td align="center">1 (1)</td><td align="center" styleCode="Rrule">2 (2)</td><td align="center">0</td><td align="center">0</td></tr><tr><td styleCode="Rrule">Diplopia</td><td align="center">2 (2)</td><td align="center" styleCode="Rrule">1 (1)</td><td align="center">1 (1)</td><td align="center">0</td></tr><tr><td styleCode="Rrule">Dry eye</td><td align="center">6 (6)</td><td align="center" styleCode="Rrule">2 (2)</td><td align="center">13 (14)</td><td align="center">4 (5)</td></tr><tr><td styleCode="Rrule">Eye complication associated with device</td><td align="center" valign="top">2 (2)</td><td align="center" styleCode="Rrule" valign="top">0</td><td align="center" valign="top">1 (1)</td><td align="center" valign="top">0</td></tr><tr><td styleCode="Rrule">Eye discharge</td><td align="center">2 (2)</td><td align="center" styleCode="Rrule">1 (1)</td><td align="center">0</td><td align="center">0</td></tr><tr><td styleCode="Rrule">Eye oedema</td><td align="center">7 (7)</td><td align="center" styleCode="Rrule">0</td><td align="center">0</td><td align="center">0</td></tr><tr><td styleCode="Rrule">Eye pain</td><td align="center">17 (17)</td><td align="center" styleCode="Rrule">3 (3)</td><td align="center">24 (26)</td><td align="center">0</td></tr><tr><td styleCode="Rrule">Eye pruritus</td><td align="center">2 (2)</td><td align="center" styleCode="Rrule">0</td><td align="center">0</td><td align="center">0</td></tr><tr><td styleCode="Rrule">Eyelid oedema</td><td align="center">5 (5)</td><td align="center" styleCode="Rrule">0</td><td align="center">5 (6)</td><td align="center">1 (1)</td></tr><tr><td styleCode="Rrule">Foreign body sensation in eyes</td><td align="center" valign="top">15 (15)</td><td align="center" styleCode="Rrule" valign="top">1 (1)</td><td align="center" valign="top">13 (14)</td><td align="center" valign="top">2 (2)</td></tr><tr><td styleCode="Rrule">Glare</td><td align="center">4 (4)</td><td align="center" styleCode="Rrule">1 (1)</td><td align="center">2 (2)</td><td align="center">0</td></tr><tr><td styleCode="Rrule">Halo vision</td><td align="center">1 (1)</td><td align="center" styleCode="Rrule">0</td><td align="center">2 (2)</td><td align="center">0</td></tr><tr><td styleCode="Rrule">Keratitis</td><td align="center">1 (1)</td><td align="center" styleCode="Rrule">0</td><td align="center">3 (3)</td><td align="center">0</td></tr><tr><td styleCode="Rrule">Lacrimation increased</td><td align="center">5 (5)</td><td align="center" styleCode="Rrule">0</td><td align="center">9 (10)</td><td align="center">1 (1)</td></tr><tr><td styleCode="Rrule">Meibomian gland dysfunction</td><td align="center" valign="top">1 (1)</td><td align="center" styleCode="Rrule" valign="top">1 (1)</td><td align="center" valign="top">3 (3)</td><td align="center">2 (2)</td></tr><tr><td styleCode="Rrule">Ocular discomfort</td><td align="center">0</td><td align="center" styleCode="Rrule">0</td><td align="center">8 (9)</td><td align="center">0</td></tr><tr><td styleCode="Rrule">Ocular hyperaemia</td><td align="center">14 (14)</td><td align="center" styleCode="Rrule">2 (2)</td><td align="center">7 (8)</td><td align="center">4 (5)</td></tr><tr><td styleCode="Rrule">Photophobia</td><td align="center">11 (11)</td><td align="center" styleCode="Rrule">0</td><td align="center">17 (19)</td><td align="center">0</td></tr><tr><td styleCode="Rrule">Punctate keratitis</td><td align="center">25 (25)</td><td align="center" styleCode="Rrule">8 (8)</td><td align="center">18 (20)</td><td align="center">3 (3)</td></tr><tr><td styleCode="Rrule">Vision blurred</td><td align="center">16 (16)</td><td align="center" styleCode="Rrule">2 (2)</td><td align="center">15 (17)</td><td align="center">4 (5)</td></tr><tr><td styleCode="Rrule">Visual acuity reduced</td><td align="center">10 (10)</td><td align="center" styleCode="Rrule">9 (9)</td><td align="center">10 (11)</td><td align="center">1 (1)</td></tr><tr><td styleCode="Rrule">Visual impairment</td><td align="center">3 (3)</td><td align="center" styleCode="Rrule">2 (2)</td><td align="center">4 (4)</td><td align="center">1 (1)</td></tr><tr><td styleCode="Rrule Botrule">Vitreous detachment</td><td align="center" styleCode="Botrule">2 (2)</td><td align="center" styleCode="Rrule Botrule">0</td><td align="center" styleCode="Botrule">0</td><td align="center" styleCode="Botrule">0</td></tr></tbody></table>
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.