Ophthalmology | Phase III Developments | UNITED STATES

Kala Pharmaceuticals

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Drug Discovery Chemistry

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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.

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.

RegeneRx Bioprmaceuticals

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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.

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.