DUGRESSA (dexaméthasone/ lévofloxacine)

Key points

Unfavourable opinion for reimbursement in the prevention and treatment of inflammation, and the prevention of infection associated with cataract surgery in adults.

Role in the care pathway?

Prevention of infections following cataract surgery

The strategy proposed in cataract surgery (Afssaps 2011 guideline) is underpinned by both compliance with good antibacterial practice in view of the safety of use of fluoroquinolones and compliance with the contraindications of cephalosporins.

On the basis of a published trial in cataract surgery, the results of which are supported by the experience of various teams, it is recommended to inject cefuroxime (1 mg / 0.1 ml) into the anterior chamber of the eye at the end of the procedure, in the absence of contraindications to the administration of cephalosporins (Grade B). There is no point in administering concomitant oral antibiotic treatment.

In the event of contraindications to the administration of cephalosporins, administration of oral levofloxacin, with a dose of 500 mg the day before surgery [16 to 12 hours before] and 500 mg on the day of surgery [4 to 2 hours before] is recommended in at-risk patients.

Postoperative topical prophylactic antibiotic therapy is recommended given the presence of a perforating incision, in order to reduce the bacterial load on the eye surface and thereby prevent postoperative intraocular infection. This is recommended postoperatively only, until the incisions are sealed (professional consensus). Given their high selectivity, topical fluoroquinolones are reserved for the curative treatment of severe eye infections.

Treatment of ocular inflammatory complications following cataract surgery

Cystoid macular oedema (CMO):

The majority of cases resolve spontaneously after a few weeks or months, but with a degree of contrast sensitivity loss or even poor vision. CMO is often treated by administering a topical corticosteroid or a sub-Tenons or intravitreal injection or by using nonsteroidal anti-inflammatory eye drops. Surgery is indicated in cases where the cause of the problem has been identified, such as vitreous loss, lens remnants or an off-centre IOL.

As a precaution, the majority of patients with diabetic retinopathy should take anti-inflammatories for prophylactic purposes after the procedure.

Toxic anterior segment syndrome (TASS):

In the event of toxic anterior segment syndrome (TASS), corticosteroid eye drops may be administered until the inflammation resolves. Frequent follow-up is also essential to monitor symptoms and reassess bacterial infection and intraocular pressure. Since TASS is initially indistinguishable from infectious endophthalmitis, it is usually diagnosed and treated in the acute phase as an infection. Inflammatory abnormalities generally regress with local corticosteroid anti-inflammatory treatment, but chronic intraocular hypertonia and/or corneal oedema may persist, as a result of irreversible trabecular or endothelial damage.

Role of the medicinal product in the care pathway

Considering:

• demonstration of the non-inferiority of the strategy using eye drops containing a combination of levofloxacin and dexamethasone for 7 days followed by 7 days of eye drops containing dexamethasone alone compared to the strategy using standard treatment with eye drops containing tobramycin and dexamethasone for 14 days, in terms of the percentage of patients with no signs of anterior chamber inflammation, without robust data on the prevention of endophthalmitis,

But taking into account:

• current guidelines (Afssaps 2011) relative to prophylactic antibiotic therapy in ophthalmological surgery specifying that, given their high selectivity, topical fluoroquinolones are reserved for the (adapted) curative treatment of severe eye infections, although this may appear to be low in view of systemic concentrations but remains unknown at locoregional level,
• the MA indication of DUGRESSA (levofloxacin, dexamethasone), which limits its use to the prevention of eye infections, with the medicinal product not intended for the curative treatment of such infections when they occur,
• the medical need already met by numerous alternatives in this antibiotic resistance context (such as combinations containing aminoglycosides),

the Committee considers that DUGRESSA (levofloxacin, dexamethasone) has no role in the care pathway for the prevention of eye infections following cataract surgery and in the concomitant treatment of inflammatory reactions (curative and preventive) following cataract surgery.