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[{"orgOrder":0,"company":"Kala Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Kala Pharmaceuticals Announces Completion of Enrollment of STRIDE 3 Trial for EYSUVIS\u2122 (KPI-121 0.25%) for Dry Eye Disease","therapeuticArea":"Ophthalmology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"January 2020","url1":"","url2":"","graph1":"Ophthalmology","graph2":"Phase III"},{"orgOrder":0,"company":"Kala Pharmaceuticals","sponsor":"Not Applicable ","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Kala Pharma Announces Significant Results in STRIDE 3 Clinical Trial","therapeuticArea":"Ophthalmology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"March 2020","url1":"","url2":"","graph1":"Ophthalmology","graph2":"Phase III"},{"orgOrder":0,"company":"Kala Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Kala Pharmaceuticals Resubmits New Drug Application for EYSUVIS\u2122 for Dry Eye Disease","therapeuticArea":"Ophthalmology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"May 2020","url1":"","url2":"","graph1":"Ophthalmology","graph2":"Phase III"},{"orgOrder":0,"company":"Kala Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Kala Pharmaceuticals Announces FDA Approval of EYSUVIS\u2122 for the Short-Term Treatment of the Signs and Symptoms of Dry Eye Disease","therapeuticArea":"Ophthalmology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"October 2020","url1":"","url2":"","graph1":"Ophthalmology","graph2":"Approved"},{"orgOrder":0,"company":"Kala Pharmaceuticals","sponsor":"Oxford Finance","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Oxford Finance Provides $125 Million Credit Facility to Kala Pharmaceuticals","therapeuticArea":"Ophthalmology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"May 2021","url1":"","url2":"","graph1":"Ophthalmology","graph2":"Approved"},{"orgOrder":0,"company":"Akorn Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Akorn Receives FDA Approval for Loteprednol Etabonate Ophthalmic Gel, 0.5%","therapeuticArea":"Ophthalmology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"February 2021","url1":"","url2":"","graph1":"Ophthalmology","graph2":"Approved"},{"orgOrder":0,"company":"Kala Pharmaceuticals","sponsor":"Alcon Inc","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"$60.0 million","newsHeadline":"Alcon to Acquire EYSUVIS Adding to Its Ophthalmic Eye Drop Portfolio","therapeuticArea":"Ophthalmology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"May 2022","url1":"","url2":"","graph1":"Ophthalmology","graph2":"Approved"}]

Find Clinical Drug Pipeline Developments & Deals for Loteprednol Etabonate

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            Details:

            The acquisition will complement Alcon’s existing portfolio in the large and fast-growing dry eye category. EYSUVIS (Loteprednol Etabonate) will complement the Systane® family of eye drops which includes the recently launched Systane Preservative-Free formulations.

            Lead Product(s): Loteprednol Etabonate

            Therapeutic Area: Ophthalmology Product Name: Eysuvis

            Highest Development Status: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: Alcon Inc

            Deal Size: Undisclosed Upfront Cash: $60.0 million

            Deal Type: Acquisition May 23, 2022

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            Details:

            Kala is marketing two approved ophthalmology products, EYSUVIS® for the short-term (up to two weeks) treatment of the signs and symptoms of dry eye disease (“DED”), and INVELTYS® for the treatment of post-operative inflammation and pain following ocular surgery.

            Lead Product(s): Loteprednol Etabonate

            Therapeutic Area: Ophthalmology Product Name: Eysuvis

            Highest Development Status: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: Oxford Finance

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Financing May 12, 2021

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            Details:

            Loteprednol Etabonate Ophthalmic Gel, 0.5% is indicated for the treatment of post-operative inflammation and pain following ocular surgery.

            Lead Product(s): Loteprednol Etabonate

            Therapeutic Area: Ophthalmology Product Name: Undisclosed

            Highest Development Status: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable February 11, 2021

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            Details:

            The FDA granted approval to EYSUVIS based on results from four clinical trials, including three Phase 3 trials and one Phase 2 trial, that demonstrated significant improvements in both the signs and symptoms of dry eye disease.

            Lead Product(s): Loteprednol Etabonate

            Therapeutic Area: Ophthalmology Product Name: Eysuvis

            Highest Development Status: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable October 27, 2020

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            Details:

            STRIDE 3 trial of EYSUVIS met both of its primary symptom endpoints, demonstrating a statistically significant improvement in ocular discomfort severity in both ITT population.

            Lead Product(s): Loteprednol Etabonate

            Therapeutic Area: Ophthalmology Product Name: Undisclosed

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable May 04, 2020

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            Details:

            STRIDE 3 met both prespecified primary efficacy endpoints, ocular discomfort severity in the overall ITT population and in ITT patients with more severe baseline discomfort.

            Lead Product(s): Loteprednol Etabonate

            Therapeutic Area: Ophthalmology Product Name: Undisclosed

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable March 09, 2020

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            Details:

            If approved, Kala plans to commercialize KPI-121 0.25% under the brand name EYSUVIS™.

            Lead Product(s): Loteprednol Etabonate

            Therapeutic Area: Ophthalmology Product Name: Undisclosed

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable January 15, 2020

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