CEQUA

Treatment must be initiated by an ophthalmologist or a healthcare professional qualified in ophthalmology. The response to treatment should be reassessed at least every 3 months. Posology The recommended dose is one drop of this medicine twice daily (approximately 12 hours apart) into the affected eye(s).

Special populations Elderly population No overall differences in safety or effectiveness have been observed between elderly and younger adult patients. No dose adjustment is required. Patients with renal or hepatic impairment The safety and efficacy of this medicine has not been studied in patients with hepatic or renal impairment.

2), and no special considerations are needed in these populations. Paediatric population The effect of this medicine has not been studied in children. There is no relevant use of this medicine in the treatment of signs of moderate to severe dry eye disease in the paediatric and adolescent population aged below 18 years.

Method of administration For ocular use. Precautions to be taken before administering the medicinal product Patients should be instructed to first wash their hands. Each Cequa single-dose container is for single use for both eyes in one patient only.

Patients should be instructed to use nasolacrimal occlusion and to close the eyelids for 2 minutes after instillation, to reduce the systemic absorption. This may result in an increase in local activity and decrease in systemic undesirable effects.

Cequa can be used concomitantly with artificial tears, allowing a 15-minute interval between products. Discard the single-dose container immediately after using in both eyes. To avoid the potential for eye injury and contamination, advise patients not to touch the single-dose container tip to the eye or other surfaces.

a. Summary of the safety profile The primary assessment of safety for this medicine is based on vehicle-controlled studies. Supportive safety data are provided by the uncontrolled safety extension of one study for long term usage, and a Phase 1 study in healthy volunteers.

In the vehicle controlled clinical studies over 520 patients were treated with this medicine. 2% in the vehicle group). The majority of adverse reactions reported in clinical studies with the use of this medicine were ocular and predominantly mild in intensity (approximately 70% of the AEs in both treatment groups were mild), and in most cases resolved without treatment or sequelae.

Adverse events of severe intensity were uncommon. 7%) were low across the OTX-101 and Vehicle groups. Long term (9 to ≥12months exposure) safety data was available from 220 patients. No new adverse reactions were identified in these patients.

The following adverse reactions listed below were observed in clinical studies. They are ranked according to system organ class and classified according to the following convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), or not known (cannot be estimated from the available data).

b. Tabulated list of adverse reactions System Organ Class Frequency Adverse reactions Common Conjunctival hyperaemia, eye irritation Uncommon Increased lacrimation, punctate keratitis, photophobia, eye pain, conjunctival oedema, blepharitis, ocular and periocular infections Eye disorders Very rare Cases of corneal calcification have been reported very rarely in association with the use of phosphate containing eye drops in some patients with significantly damaged corneas.

8c c. Description of selected adverse reactions Instillation site pain Instillation site pain was very common observed in users of Cequa. Typically, it occurs immediately after instillation but is of a short duration (seconds to a few minutes), and resolves without further action being required.

Use with Contact Lenses Cequa has not been studied in patients wearing contact lenses. If contact lenses are worn, they should be removed prior to administration of the solution. Lenses may be reinserted 15 minutes following administration of this medicine ophthalmic solution.

Concomitant therapy Ciclosporin treatment experience in patients with glaucoma is limited. When treating these patients concomitantly with this medicine it is recommended to have a regular clinical monitoring, especially with beta-blockers which are known to decrease tear secretion.

Infections Resolve existing or suspected ocular or peri-ocular infections before initiating Cequa treatment. If an infection occurs during treatment, this medicine should be temporarily withheld until the infection has been resolved.

Effects on the immune system Ophthalmic medicinal products, which affect the immune system, including ciclosporin, may affect host defences against local infections and malignancies. A regular examination of the eye(s) is recommended.

Phosphates content Cequa contains phosphates. Phosphates may cause in very rare cases cloudy patches on the cornea due to calcium build-up during treatment.

1 List of excipients. Ocular or peri-ocular malignancies or premalignant conditions. 4).