CyclosporineOphthalmicEmulsion.pptVIP

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CyclosporineOphthalmicEmulsion.ppt

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CyclosporineOphthalmicEmulsion

Cyclosporine Ophthalmic Emulsion, 0.05% Cyclosporine Ophthalmic Emulsion, 0.05% Pharmacologic Category - immunomodulator Proposed Indication - treatment of moderate to severe keratoconjunctivitis sicca Dosage Form and Route of Administration - ophthalmic emulsion for topical administration Clinical Data Sources Two Phase 3 Protocols Protocol 192731-002 Protocol 192731-003 One Phase 2 Protocol Protocol 192731-001 Protocol 192731-002 Clinical Studies Protocol 192731-002 Design - randomized, multicenter, parallel-group, double-masked, Phase 3 trial Treatment arms - cyclosporine 0.05%, cyclosporine 0.1% , common vehicle Protocol 192731-002 Test drug schedule - all subjects received either cyclosporine 0.05%, 0.1% or vehicle bilaterally, BID for six months Total subjects - 405 Protocol 192731-002 Objective Signs: corneal staining conjunctival staining sum of corneal and interpalpebral conjunctival staining Schirmer Tear Test tear break-up time Protocol 192731-002 Subjective Symptoms: symptoms of dry eye Ocular Surface Disease Index Score (OSDI) Facial Expression Subjective Rating Scale Investigator’s Global Evaluation of Response to Treatment Treatment Success Protocol 192731-002 Criteria for Effectiveness - Sponsor must show a statistically significant difference between the active treatment and the vehicle for one (1) objective sign and one (1) subjective symptom. Protocol 192731-002 Safety Criteria: EDTRS visual acuity intraocular pressure biomicroscopy pharmacokinetic parameters for subsets of subjects in selected centers Protocol 192731-002 - Objective Signs Protocol 192731-002 - Objective Signs Protocol 192731-002 - Subjective Symptoms Protocol 192731-002 - Subjective Symptoms Protocol 192731-002 - Subjective Symptoms Protocol 192731-002 - Subjective Symptoms Protocol 192731-002 - Subjective Symptoms Protocol 192731-002 - Subjective Symptoms Protocol 192731-002 - Subjective Symptoms Protocol 192731-002Safety Adverse Events Monitoring Most Common Ocu