Levofloxacin / Dexamethason (1) – Ducressa®
Infections and inflammations associated with cataract surgery
Characteristics
| Start date | 01.02.2021 – Marketing authorisation: 07.09.2020 |
|---|---|
| Resolution | 15.07.2021 |
| INN | Levofloxacin/Dexamethason |
| Brand name | Ducressa® |
| Pharm. company | Santen GmbH |
| G-BA Procedure ID | D-636 |
| ATC code | S01CA01 Corticosteroids and antiinfectives in combination (S01CA) |
| ICD-10 codes (AIS) | H25.0Age-related incipient cataract, H25.1Cataracta brunescens, H25.2Age-related hypermature cataract, H25.8Other age-related cataract, H25.9Unspecified age-related cataract, H26.0Infantile and juvenile cataract, H26.1Traumatic cataract, H26.2Complicated cataract, H26.3Toxic cataract, H26.4Secondary cataract, H26.8Other specified cataract, H26.9Unspecified cataract |
| Alpha-ID codes (AIS) | I11745Presence cataract, I13576Cataract, I28234Cataracta senilis, I28238Cataracta senilis incipiens, I4188Cataracta nuclearis senilis, I4189Cataracta senilis of the Morgagni type, I4195Cataracta traumatica, I4202Cataracta complicata, I4208Drug-induced cataract, I4209Cataracta secundaria, I4217Cataracta corticonuclearis, I95420Cataracta senilis, mixed form |
| DDD | 0.12 ml eye drops |
| Therapeutic area | Eye diseases Postoperative eye inflammation after cataract extraction |
| Reason for procedure | Initial assessment |
| Therapeutic indication of the resolution |
|---|
|
Ducressa is used to prevent and treat inflammation and to prevent infections associated with cataract surgery in adults. |
| Subpopulation | Indication | Comparator |
|---|---|---|
| Adults for the prevention and treatment of inflammation and for the prevention of infections associated with cataract surgery. | A combination of local antibiotic therapy (cefuroxime, polymyxin-B/neomycin/gramicidin, tobramycin, gentamicin, neomycin) in conjunction with antiphlogistic monotherapy or combination therapy: corticosteroid e.g. rimexolone, dexamethasone, fluorometholone, prednisolone, loteprednoletabonate and/or NSAID e.g. diclofenac, neomycin). e.g. rimexolone, dexamethasone, fluorometholone, prednisolone, loteprednoletabonate and/or NSAID e.g. diclofenac, nepafenac, indometacin, ketorolac |
Studies and Results
|
No. of studies
(best subpopulation) |
1 (LEADER-7) |
|---|---|
|
Study design
(best subpopulation) |
H2H vs. ACT |
|
Meta analysis
(best subpopulation) |
no |
Adults for the prevention and treatment of inflammation and for the prevention of infections associated with cataract surgery
- Additional benefit is not proven
- There is no evidence of additional benefit for the combination of levofloxacin and dexamethasone in adults for the prevention and treatment of inflammation and for the prevention of infections associated with cataract surgery, compared with the appropriate comparator therapy, tobramycin andThere is no proof that dexamethasone is effective.
- mortality
- No statistically significant difference was observed between the treatment arms for the endpoint of overall mortality.
- Morbidity – endophthalmitis
- The endpoint of endophthalmitis was recorded on days 4, 8 and 15 of the study.
- No cases of endophthalmitis occurred during the study.
- Morbidity – itching/burning, conjunctival redness, tearing and ocular pain/discomfort (each assessed as absence of symptoms)
- For the endpoints of itching/burning, conjunctival redness, tearing and ocular pain/discomfort (each considered as freedom from symptoms), no statistically significant differences were observed between the treatment arms at any assessment time point.
- Morbidity – Decrease in visual acuity
- For the endpoint of reduced visual acuity, assessed using the Snellen or Early Treatment of Diabetic Retinopathy Study (ETDRS) chart in accordance with local clinical practice, no statistically significant difference was observed between the treatment arms.
- Health-related quality of life
- No endpoints relating to health-related quality of life were assessed in the LEADER-7 study.
- Side effects – severe adverse events (SUEs) and discontinuation due to adverse events (UEs)
- For the endpoints SUE and discontinuation due to AEs, no statistically significant differences were observed between the treatment arms.
- Overall assessment / Conclusion
- For adults, regarding the prevention and treatment of inflammation and the prevention of infections associated with cataract surgery, results are available from the head-to-head LEADER-7 trial comparing levofloxacin/dexamethasone with tobramycin/dexamethasone.
- In summary, there were no statistically significant differences between the treatment arms in the results for mortality or morbidity.
- No endpoints were assessed in the category of health-related quality of life.
- In the category of side effects, no overall advantages or disadvantages can be identified for levofloxacin/dexamethasone compared with tobramycin/dexamethasone.
- Consequently, there is no evidence of additional benefit for the combination of levofloxacin and dexamethasone in adults for the prevention and treatment of inflammation, as well as for the prevention of infections associated with cataract surgery, compared with the appropriate comparator therapy, tobramycin andThere is no proof that dexamethasone is effective.
Courtesy translation only, please refer to the German original.
Associated procedures
| Levofloxacin / Dexamethason (1) | Ducressa® | Santen GmbH | Infections and inflammations associated with cataract surgery | 454,000–811,000 | 100% additional benefit not proven |
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