Kala Pharmaceuticals

Kala Pharmaceuticals

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  KALA PHARMACEUTICALS |Ophthalmology Innovation Summit| April 2015 | Page 1 Charles McDermott Interim President and CBO Ophthalmology Innovation Summit – April 2015 Penetrating mucosal barriers to maximize ocular therapeutic outcome
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  KALA PHARMACEUTICALS |Ophthalmology Innovation Summit| April 2015 | Page 2 MPP Platform Technology: Successful Clinical Translation • Advancing mucus-penetrating particle (MPP) technology based ophthalmic product candidates into late stage clinical development • Translation from research stage technology to positive phase 2 and 3 clinical trials in less than 2 years. Kala Eyecare Focus: Front, Middle, and Back of the Eye • Topical formulations target multiple ophthalmic indications affecting the front, middle, and back of the eye • KPI-121 hit all primary endpoints in first phase 3 trial in cataract surgery and hit the primary sign endpoint in initial phase 2 dry eye trial. • Novel RTKis formulated in MPP technology for retinal disease progressing toward IND stage development Kala Pharmaceuticals: Phase 3 Stage Company
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  KALA PHARMACEUTICALS |Ophthalmology Innovation Summit| April 2015 | Page 3 Kala’s Eye Care Pipeline C O N F I D E N T I A L Discovery Pre- clinical Phase I Phase II Phase III NDA KPI-121 Ophthalmic MPP Suspension Post-surgical Inflammation KPI-121 Ophthalmic MPP SuspensionDry Eye KPI-121 Ophthalmic MPP Suspension Meibomian Gland Disease RTKi* MPP (topical)) AMD/DME/ RVO/Orphan Exploratory Glaucoma 1st Phase 3 trial complete Phase 2/3 trial complete Phase 2 trial ongoing KPI-121 = Kala’s Loteprednol Etabonate Mucus Penetrating Nano-Particle Formulation RTKi = Kala’s Novel Receptor Tyrosine Kinase Inhibitors in MPP Formulations
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  KALA PHARMACEUTICALS |Ophthalmology Innovation Summit| April 2015 | Page 4 KPI-121: Phase 3 Post-Surgical Results KPI-121: statistically significant improvements for both primary endpoints Primary Endpoints: Inflammation and Pain
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  KALA PHARMACEUTICALS |Ophthalmology Innovation Summit| April 2015 | Page 5 KPI-121: Phase 2 Dry Eye Sign Results KPI-121: statistically significant improvements in the primary sign endpoint – bulbar conjunctival hyperemia Primary Sign Endpoint: Conjunctival Hyperemia
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  KALA PHARMACEUTICALS |Ophthalmology Innovation Summit| April 2015 | Page 6 KPI-121: Phase 2 Dry Eye Symptoms Results KPI-121: improvements in both severity and frequency of symptoms Primary Endpoint: Discomfort Severity Secondary Endpoint: Discomfort Frequency
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  KALA PHARMACEUTICALS |Ophthalmology Innovation Summit| April 2015 | Page 7 Kala Topical RTKis to Treat BOE Diseases • Novel compounds with potent VEGFR2 inhibition and good selectivity • Demonstrated topical delivery to back of the eye in large animals • Demonstrated efficacy in VEGF driven rabbit leakage model
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  KALA PHARMACEUTICALS |Ophthalmology Innovation Summit| April 2015 | Page 8 Clinical Results: Successful Translation of MPP into Patients • KPI-121 positive clinical results validates MPP technology applicability in ophthalmology Kala’s Next Steps: • Advance development of KPI-121 in dry eye and post operative inflammation. • Readout of KPI-121 phase 2 trial in MGD. • Advance RTKi program to clinical development candidate for VEGF driven indications. • Continue discussions with prospective partners regarding KPI-121 and MPP technology applications in new areas. Additional Applications: Women’s Health, GI, and Respiratory • In-vivo data across many classes of compounds show promise in therapeutic areas beyond ophthalmology. Kala Driving Late Stage KPI-121 Clinical Development