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Find Ophthalmology Drugs in Phase III Clinical Development

A collaboration with SCORR Marketing

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            Lead Product(s): Loteprednol Etabonate

            Therapeutic Area: Ophthalmology

            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

            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.

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            Lead Product(s): Lenadogene nolparvovec

            Therapeutic Area: Ophthalmology

            Highest Development Status: Phase III Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable March 03, 2020

            Details:

            Bilateral visual recovery observed with GS010 in the REVERSE and RESCUE Phase III trials will be presented and discussed at the 46th Annual Meeting of the North American Neuro-Ophthalmology Society.

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            Lead Product(s): Bimatoprost

            Therapeutic Area: Ophthalmology

            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 February 25, 2020

            Details:

            A New Drug Application (NDA) for Bimatoprost SR is currently under review with the U.S. Food and Drug Administration, and if approved, has the potential to be the first and only biodegradable.

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            Lead Product(s): Emixustat Hydrochloride

            Therapeutic Area: Ophthalmology

            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 February 13, 2020

            Details:

            The company has achieved over 65% subject enrollment in its ongoing phase 3 clinical trial investigating emixustat hydrochloride in patients with macular atrophy secondary to Stargardt disease.

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            Lead Product(s): Ranibizumab

            Therapeutic Area: Ophthalmology

            Highest Development Status: Phase III Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable February 04, 2020

            Details:

            Bioeq has decided to withdraw its BLA application for the Lucentis® biosimilar candidate, provide the requested data and resubmit the application thereafter, which may delay the approval of the BLA.

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            Lead Product(s): Thymosin Beta-4

            Therapeutic Area: Ophthalmology

            Highest Development Status: Phase III Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable February 03, 2020

            Details:

            ARISE-3 will enroll over 700 eye dry patients at 19 eye clinics across the U.S. for two weeks of treatment, comparing the safety and efficacy of RGN-259 against placebo.

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            Lead Product(s): Bevacizumab

            Therapeutic Area: Ophthalmology

            Highest Development Status: Phase III Product Type: Large molecule

            Partner/Sponsor/Collaborator: BioLexis Pte. Ltd

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Agreement January 28, 2020

            Details:

            Outlook Therapeutics signed agreement with BioLexis Pte. Ltd to better align the interests of all parties with common stockholders of the Company and to help ONS-5010's continuing development.

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            Lead Product(s): Triamcinolone Acetonide

            Therapeutic Area: Ophthalmology

            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 28, 2020

            Details:

            The data demonstrated that patients with noninfectious uveitis in the XIPERE study arm experienced clinically significant improvement in vision relative to the control arm.

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            Lead Product(s): Reproxalap

            Therapeutic Area: Ophthalmology

            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 21, 2020

            Details:

            The INVIGORATE Trial, which will enroll approximately 120 patients aims to assess the efficacy and safety of reproxalap ophthalmic solution (0.25%) compared with vehicle using an allergen chamber.

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            Lead Product(s): Loteprednol Etabonate

            Therapeutic Area: Ophthalmology

            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

            Details:

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

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