Unsuitable

Unsuitable

Unsuitable

Unsuitable

Limited published evidence of safety

Small amounts in breast milk

Monitor infant plasma levels if there is a concern about toxicity

Limited published evidence of safety

Small amounts in breast milk

Monitor infant plasma levels if there is a concern about toxicity

Limited published evidence of safety

Small amounts in breast milk

Monitor for signs of infection, immunosuppression, and infant plasma levels (if there is a concern about toxicity)

Limited published evidence of safety

Small amounts in breast milk

Monitor infant plasma levels if there is a concern about toxicity

Jan 19 · No longer listed in Allergan pipeline, and no new information available to suggest there are plans to launch in the EU; assume development discontinued in EU [13,14].

May 18 · Allergan have withdrawn the marketing authorisation application. At the time of withdrawal, the CHMP had notified the company that it was of the provisional opinion that the application could not have been approved. The Committee felt that the results presented by the company were not robust enough to demonstrate effectiveness, in particular the way that results for moderate dry eye disease had been analysed. The company´s letter to the CHMP leaves open the possibility of re-submission in the future [12].

Aug 17 · Currently pre-registration in EU [11].

Aug 17 · No information available on current plans for a EU licence [10].

Oct 16 · Allergan launches new multidose, preservative-free formulation of ciclosporin 0.05% ophthalmic emulsion (Restasis Multidose) in the US [9].

Mar 16 · FDA issues a complete response letter on a multidose, preservative-free formulation of Restasis, asking for more information about the bottle--a "first-of-its-kind" container, Allergan says, with a uni-directional valve and air filter technology that the company has patented [8].

Mar 15 · Listed as PIII in EU in Allergen´s pipeline [6].

Mar 13 · PIII in the EU [1].

Jul 09 · Orphan designation (EU/3/09/651) granted by the European Commission to Allergan for ciclosporin eye drops for treatment of atopic keratoconjunctivitis [5].

Apr 03 · Launched in the US for treatment of moderate-to-severe dry eye due to ocular inflammation (keratoconjunctivitis sicca) [2].

Keratoconjunctivitis sicca, also known as dry eye syndrome, is a common condition caused by a disorder of the tear film. Reported prevalence rates are 15-33% in people aged 65 and over. It is around 50% more common in women than in men, & can have significant effects on quality of life & common vision-related daily activities, such as driving & reading [3].

Jan 16 · From US Product Label: Four multicenter, randomized, adequate and well-controlled clinical studies were performed in approximately 1,200 patients with moderate to severe keratoconjunctivitis sicca. RESTASIS® demonstrated statistically significant increases in Schirmer wetting of 10 mm versus vehicle at six months in patients whose tear production was presumed to be suppressed due to ocular inflammation. This effect was seen in approximately 15% of RESTASIS® ophthalmic emulsion-treated patients versus approximately 5% of vehicle-treated patients. Increased tear production was not seen in patients currently taking topical anti-inflammatory drugs or using punctal plugs [7].

Mar 13 · Data from pivotal PIII trials indicates that Restasis produces significant & clinically relevant increases in Schirmer scores of wetting at 6 months, compared with vehicle. The Schirmer test measures the amount of tears produced in the eye. No increases in tear production were observed in pts taking topical anti-inflammatories or using punctal plugs [2].

FDA doc

Bronchiolitis obliterans syndrome is a rare condition which can occur due to chronic GVHD that causes damage to lungs or following lung transplant and allogeneic hematopoietic stem cell transplants.[1,2]