Reason for request

Extension of Inclusion

No demonstrated clinical benefit in the reduction of elevated intraocular pressure in children

  • XALATAN now has marketing authorisation in reduction of elevated intraocular pressure in paediatric patients with elevated intraocular pressure (IOP) and paediatric glaucoma.
  • A randomised clinical study demonstrated its non-inferiority relative to timolol on mean reduction of intraocular pressure IOP after 12 weeks of treatment. 
  • XALATAN contains benzalkonium chloride in its formulation and no long-term safety data are available.
  • XALATAN, like other eye drops, can be useful short-term, while awaiting surgery, or as an additional treatment with surgery whose result is insufficient, as well as long-term in other less aggressive forms of paediatric glaucoma.

 


Clinical Benefit

Substantial

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Clinical Added Value

no clinical added value

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Therapeutic use

-

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