Ophthalmology | Phase III Developments

Kala Pharmaceuticals

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Kala Pharma Announces Significant Results in STRIDE 3 Clinical Trial

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.

GenSight Biologics

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FRANCE France

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GenSight Biologics Announces Presentation of Bilateral Visual Recovery From GS010 Phase III Trials

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.

Allergan plc

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IRELAND Ireland

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Allergan to Present New Data for Investigational Bimatoprost Sustained-Release at American Glaucoma Society Annual Meeting

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.

Acucela

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Acucela Provides Update on Emixustat Phase 3 Clinical Trial in Patients with Stargardt Disease

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.

Formycon

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GERMANY Germany

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Formycon Announce current Status of BLA Review of FYB201

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.

RegeneRx Bioprmaceuticals

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United States

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RegeneRx Partner Updates on Phase 3 Dry Eye Trial

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.

Outlook Therapeutics

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Outlook Therapeutics Announces Agreements to Streamline Capital Structure and Regain 100% Ownership of Any Future Net Profits for ONS-5010

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.

Bausch Health

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CANADA Canada

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Bausch Health and Clearside Biomedical Announce Publication of PIVOTAL Phase 3 Data ON XIPERETM (triamcinolone acetonide suprachoroidal inje...

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.

Aldeyra Therapeutics

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Aldeyra Therapeutics Announces First Patient Enrolled in the Phase 3 INVIGORATE Trial in Allergic Conjunctivitis

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.

Kala Pharmaceuticals

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Kala Pharmaceuticals Announces Completion of Enrollment of STRIDE 3 Trial for EYSUVIS™ (KPI-121 0.25%) for Dry Eye Disease

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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Kala Pharmaceuticals

Kala Pharma Announces Significant Results in STRIDE 3 Clinical Trial

GenSight Biologics

GenSight Biologics Announces Presentation of Bilateral Visual Recovery From GS010 Phase III Trials

Allergan plc

Allergan to Present New Data for Investigational Bimatoprost Sustained-Release at American Glaucoma Society Annual Meeting

Acucela

Acucela Provides Update on Emixustat Phase 3 Clinical Trial in Patients with Stargardt Disease

Formycon

Formycon Announce current Status of BLA Review of FYB201

RegeneRx Bioprmaceuticals

RegeneRx Partner Updates on Phase 3 Dry Eye Trial

Outlook Therapeutics

Outlook Therapeutics Announces Agreements to Streamline Capital Structure and Regain 100% Ownership of Any Future Net Profits for ONS-5010

Bausch Health

Bausch Health and Clearside Biomedical Announce Publication of PIVOTAL Phase 3 Data ON XIPERETM (triamcinolone acetonide suprachoroidal inje...

Aldeyra Therapeutics

Aldeyra Therapeutics Announces First Patient Enrolled in the Phase 3 INVIGORATE Trial in Allergic Conjunctivitis

Kala Pharmaceuticals

Kala Pharmaceuticals Announces Completion of Enrollment of STRIDE 3 Trial for EYSUVIS™ (KPI-121 0.25%) for Dry Eye Disease