Ophthalmology | Phase I Developments

Adverum Biotechnologies

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Adverum Announces Positive Interim Data from Cohorts 1-4 from OPTIC Phase 1 Trial of ADVM-022 Intravitreal Gene Therapy for wet AMD

Lead Product(s): AAV.7m8-Aflibercept

Therapeutic Area: Ophthalmology Product Name: ADVM-022

Highest Development Status: Phase I Product Type: Cell and Gene therapy

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable August 10, 2020

Details:

Early evidence from Cohort 4, consistent with Cohort 3, suggests that a prophylactic regimen of steroid eye drops results in fewer adverse events and less inflammation, when compared to a prophylactic regimen of oral steroids as used in Cohorts 1 and 2. In Cohorts 3 and 4.

Belite Bio

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Belite Bio Announces Positive Results from Phase 1 Clinical Trials of LBS-008

Lead Product(s): LBS-008

Therapeutic Area: Ophthalmology Product Name: BPN-14967

Highest Development Status: Phase I Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable July 20, 2020

Details:

A total of 83 subjects were administered with LBS-008 either as a single dose or repeated doses for 14 consecutive days. Both studies concluded that pharmacological doses of LBS-008 were well tolerated and that LBS-008's PK / PD profile supports daily oral administration.

Adverum Biotechnologies

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Adverum Biotechnologies Completes Patient Dosing in Cohort 4 of OPTIC Phase 1 Trial of ADVM-022 Single Injection Gene Therapy for Wet AMD

Lead Product(s): AAV.7m8-aflibercept

Therapeutic Area: Ophthalmology Product Name: ADVM-022

Highest Development Status: Phase I Product Type: Cell and Gene therapy

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable July 06, 2020

Details:

Adverum Biotechnologies announced the completion of patient dosing in Cohort 4 of OPTIC, a Phase 1 clinical trial, assessing a single intravitreal (IVT) injection of ADVM-022 in patients with wet age-related macular degeneration (AMD).

Ocular Therapeutix

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Ocular Therapeutix™ Announces First Patient Dosed in Phase 1 Clinical Trial of OTX-CSI for the Treatment of Dry Eye Disease

Lead Product(s): Cyclosporin A

Therapeutic Area: Ophthalmology Product Name: Undisclosed

Highest Development Status: Phase I Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable May 12, 2020

Details:

The study will evaluate safety and tolerability of OTX-CSI and assess biological activity by measuring signs and symptoms of DED over this time period.

Allakos

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Allakos Announces a Presentation of Antolimab in Patients with Severe Allergic Conjunctivitis at the 2020 ASCRS Virtual Annual Meeting

Lead Product(s): Antolimab

Therapeutic Area: Ophthalmology Product Name: Undisclosed

Highest Development Status: Phase I Product Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable May 11, 2020

Details:

The presentation will showcase results from Phase 1b Study of an Anti-Siglec-8 Monoclonal Antibody, Antolimab (AK002), in Severe Allergic Conjunctivitis.

Adverum Biotechnologies

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Adverum Biotechnologies Reports Interim Data from Cohorts 1-3 of OPTIC Phase 1 Trial of ADVM-022 Intravitreal Gene Therapy for Wet AMD

Lead Product(s): AAV.7m8-aflibercept

Therapeutic Area: Ophthalmology Product Name: Undisclosed

Highest Development Status: Phase I Product Type: Cell and Gene therapy

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable May 04, 2020

Details:

In the OPTIC Phase 1 Trial ADVM-022 continued to show robust efficacy. Long-term durability beyond 1 year from a single IVT injection with zero rescue injections in Cohort 1.

Adverum Biotechnologies

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Adverum Biotechnologies Announces Virtual Presentations of Data through ASGCT and ARVO

Lead Product(s): AAV.7m8-aflibercept

Therapeutic Area: Ophthalmology Product Name: Undisclosed

Highest Development Status: Phase I Product Type: Cell and Gene therapy

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable April 30, 2020

Details:

Adverum Biotechnologies to present data of ADVM-022 Intravitreal Gene Therapy for Neovascular AMD - results from the Phase 1 OPTIC Study.

Adverum Biotechnologies

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Adverum Biotechnologies Doses First Patient in Cohort 4 of OPTIC Phase 1 Clinical Trial of ADVM-022 Intravitreal Gene Therapy for Wet AMD

Lead Product(s): AAV.7m8-aflibercept

Therapeutic Area: Ophthalmology Product Name: Undisclosed

Highest Development Status: Phase I Product Type: Cell and Gene therapy

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable April 27, 2020

Details:

Patients in Cohort 4 are receiving a single intravitreal injection of gene therapy candidate ADVM-022 and are receiving steroid eye drop prophylaxis for six weeks (same as Cohort 3).

Ocular Therapeutix

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Ocular Therapeutix Provides Update on Interim Data from the OTX-TKI Phase 1 Clinical Trial

Lead Product(s): OTX-TKI

Therapeutic Area: Ophthalmology Product Name: Undisclosed

Highest Development Status: Phase I Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable March 03, 2020

Details:

Two cohorts of six subjects each have been enrolled, a lower dose cohort of 200 ?g and a higher dose cohort of 400 ?g.

Aerpio Pharmaceuticals

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Aerpio Pharmaceuticals Presents Data from Fifth Patient Cohort

Lead Product(s): Razuprotafib,Prostaglandin

Therapeutic Area: Ophthalmology Product Name: Undisclosed

Highest Development Status: Phase I Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable February 10, 2020

Details:

The Phase 1b trial is a randomized, double-masked study designed to assess increasing concentrations of AKB-9778 dosed topically as eye drops.

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Adverum Biotechnologies

Adverum Announces Positive Interim Data from Cohorts 1-4 from OPTIC Phase 1 Trial of ADVM-022 Intravitreal Gene Therapy for wet AMD

Belite Bio

Belite Bio Announces Positive Results from Phase 1 Clinical Trials of LBS-008

Adverum Biotechnologies

Adverum Biotechnologies Completes Patient Dosing in Cohort 4 of OPTIC Phase 1 Trial of ADVM-022 Single Injection Gene Therapy for Wet AMD

Ocular Therapeutix

Ocular Therapeutix™ Announces First Patient Dosed in Phase 1 Clinical Trial of OTX-CSI for the Treatment of Dry Eye Disease

Allakos

Allakos Announces a Presentation of Antolimab in Patients with Severe Allergic Conjunctivitis at the 2020 ASCRS Virtual Annual Meeting

Adverum Biotechnologies

Adverum Biotechnologies Reports Interim Data from Cohorts 1-3 of OPTIC Phase 1 Trial of ADVM-022 Intravitreal Gene Therapy for Wet AMD

Adverum Biotechnologies

Adverum Biotechnologies Announces Virtual Presentations of Data through ASGCT and ARVO

Adverum Biotechnologies

Adverum Biotechnologies Doses First Patient in Cohort 4 of OPTIC Phase 1 Clinical Trial of ADVM-022 Intravitreal Gene Therapy for Wet AMD

Ocular Therapeutix

Ocular Therapeutix Provides Update on Interim Data from the OTX-TKI Phase 1 Clinical Trial

Aerpio Pharmaceuticals

Aerpio Pharmaceuticals Presents Data from Fifth Patient Cohort