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Opus Genetics, Inc. (IRD)

Opus Genetics, Inc. is a clinical-stage biopharmaceutical company focused on ophthalmology. The company is dedicated to discovering and commercializing innovative therapies to address significant unmet medical needs in patients suffering from refractive and retinal eye disorders. Its portfolio includes Phentolamine Ophthalmic Solution, currently used to reverse pharmacologically induced mydriasis (pupil dilation). This solution is also advancing through Phase III clinical trials for the treatment of presbyopia and impaired vision in dim light or at night. A leading candidate in its retinal pipeline is APX3330, a small-molecule inhibitor targeting the reduction oxidation effector factor-1 protein. APX3330 has successfully completed Phase II clinical trials for diabetic retinopathy. Furthermore, Opus Genetics is developing APX2009 and APX2014, two preclinical product candidates also aimed at various retinal indications. Originally founded in 2018 as Ocuphire Pharma, Inc., the company maintains its headquarters in Farmington Hills, Michigan.

Sector: Pharmaceutical Preparations

Industry: Biotechnology

Opus Genetics, Inc. logo

Opus Genetics, Inc.

NASDAQ:IRDHealthcare
+0.55%$3.67
AH$3.68+0.27%vs close
Mkt Cap$305.33M
Float62.26M
O/S83.2M
Vol
$ Vol
RVOL
Inst Own69.1%
Earnings
Dilution
Opus Genetics, Inc. logoNASDAQ:IRD$3.67+0.55%
Phase Distribution
23 lead-sponsored trials·4 active·17 completed
Phase 1/25
Phase 210
Phase 38
Status Overview
Recruiting4
Completed17
Stopped2

Trials need funding. See this company's dilution risk and cash position.

Clinical Trials
Status
Phase
  • Phase 3
    Completed

    Safety and Efficacy of Nyxol (0.75% Phentolamine Ophthalmic Solution) to Reverse Pharmacologically-Induced Mydriasis

    Phentolamine Ophthalmic Solution 0.75%

    Mydriasis, Dilation

    Enrollment
    185
    Start
    Nov 2020
    Primary Completion
    Dec 2020
    Completion
    Mar 2021
    NCT04620213
  • Phase 3
    Completed

    Safety and Efficacy of Nyxol (0.75% Phentolamine Ophthalmic Solution) in Subjects With Dim Light Vision Disturbances

    Phentolamine Ophthalmic Solution 0.75%, Phentolamine Ophthalmic Solution Vehicle (Placebo)

    Dim Light Vision Disturbances

    Enrollment
    144
    Start
    Dec 2020
    Primary Completion
    May 2022
    Completion
    May 2022
    NCT04638660
  • Phase 3
    Completed

    Safety and Efficacy of Nyxol (0.75% Phentolamine Ophthalmic Solution) to Reverse Pharmacologically-Induced Mydriasis (MIRA-3)

    Phentolamine Ophthalmic Solution 0.75%, Phentolamine Ophthalmic Solution Vehicle

    Mydriasis, Dilation

    Enrollment
    368
    Start
    Nov 2021
    Primary Completion
    Mar 2022
    Completion
    Mar 2022
    NCT05134974
  • Phase 3
    Completed

    Nyxol (0.75% Phentolamine Ophthalmic Solution) to Reverse Pharmacologically-Induced Mydriasis in Pediatric Subjects

    Phentolamine Ophthalmic Solution 0.75%, Phentolamine Ophthalmic Solution Vehicle

    Mydriasis, Dilation

    Enrollment
    23
    Start
    Dec 2021
    Primary Completion
    Apr 2022
    Completion
    Apr 2022
    NCT05223478
  • Phase 3
    Completed

    Safety and Efficacy of Nyxol Eye Drops as a Single Agent and With Adjunctive Low-Dose Pilocarpine Eye Drops in Subjects With Presbyopia

    Phentolamine Opthalmic Solution 0.75%, Low dose pilocarpine

    Presbyopia

    Enrollment
    333
    Start
    Dec 2022
    Primary Completion
    Oct 2023
    Completion
    Oct 2023
    NCT05646719
  • Phase 3
    Completed

    Safety and Efficacy of 0.75% Phentolamine Ophthalmic Solution in Subjects With Post-refractive Surgery Visual Disturbances

    phentolamine ophthalmic solution 0.75%, a non-selective alpha-1 and alpha-2 adrenergic antagonist, Placebo

    Mesopic Vision, Night Vision Loss

    Enrollment
    200
    Start
    Apr 2024
    Primary Completion
    Apr 2025
    Completion
    Feb 2026
    NCT06349759
  • Phase 3
    Completed

    Evaluate Efficacy and Safety of POS to Improve Distance-corrected Near Visual in Participants With Presbyopia

    0.75% phentolamine ophthalmic solution, Placebo

    Presbyopia

    Enrollment
    569
    Start
    Aug 2024
    Primary Completion
    Apr 2025
    Completion
    Jan 2026
    NCT06542497
  • Phase 3
    Recruiting

    OPI-NXYDLD-303 Safety and Efficacy of Phentolamine Ophthalmic Solution in Keratorefractive Surgery Participants With Decreased Mesopic Visual Acuity

    0.75% Phentolamine Ophthalmic Solution, Placebo

    Vision Loss Night, Vision Disorders

    Enrollment
    580
    Start
    Sep 2025
    Primary Completion
    Aug 2027est.
    Completion
    Aug 2027est.
    NCT07140783
  • Phase 2
    Completed

    Efficacy Study of RX-10100 to Treat Erectile Dysfunction (ED)

    Placebo, RX-10100 5mg

    Erectile Dysfunction (ED)

    Enrollment
    40
    Start
    Jun 2008
    Primary Completion
    Mar 2009
    Completion
    May 2009
    NCT00693056
  • Phase 2
    Completed

    Efficacy Study of RX-10100 to Treat Major Depressive Disorder (MDD)

    RX-10100

    Major Depressive Disorder (MDD)

    Enrollment
    118
    Start
    Jan 2009
    Primary Completion
    Sep 2009
    Completion
    Oct 2009
    NCT00839176
  • Phase 2
    Completed

    A Safety and Efficacy Study of RX-0201 Plus Gemcitabine in Metastatic Pancreatic Cancer

    RX-0201 plus Gemcitabine

    Metastatic Pancreatic Cancer

    Enrollment
    31
    Start
    May 2009
    Primary Completion
    Jul 2012
    Completion
    Aug 2012
    NCT01028495
  • Phase 2
    Completed

    Safety and Efficacy of RX-10100 to Treat Major Depressive Disorder

    RX-10100

    Major Depressive Disorder

    Enrollment
    314
    Start
    Dec 2010
    Primary Completion
    Sep 2011
    Completion
    Oct 2011
    NCT01273376
  • Phase 2
    Completed

    The Safety and Efficacy of Phentolamine Mesylate Ophthalmic Solution in Subjects With Severe Night Vision Disturbances

    Phentolamine Mesylate Ophthalmic Solution 1.0%, Phentolamine Mesylate Ophthalmic Solution 0.5%

    Night Vision Complaints, Decrease in Night Vision +1

    Enrollment
    60
    Start
    Sep 2011
    Primary Completion
    Apr 2012
    Completion
    Apr 2012
    NCT01703559
  • Phase 2
    Completed

    Safety and Efficacy of Ophthalmic Phentolamine Mesylate in Glaucoma

    Phentolamine Mesylate Ophthalmic Solution 1%

    Open Angle Glaucoma, Ocular Hypertension

    Enrollment
    39
    Start
    May 2019
    Primary Completion
    Sep 2019
    Completion
    Sep 2019
    NCT03960866
  • Phase 2
    Completed

    Single Dose Study of Phentolamine Mesylate Eye Drops in Patients With Severe Night Vision Disturbances

    Phentolamine Mesylate Ophthalmic Solution 1%

    Decrease in Night Vision, Disturbance; Vision, Loss

    Enrollment
    24
    Start
    Aug 2007
    Primary Completion
    Oct 2007
    Completion
    Feb 2008
    NCT04004507
  • Phase 2
    Completed

    Safety and Efficacy of Ophthalmic Phentolamine Mesylate to Reverse Pharmacologically Induced Mydriasis

    Phentolamine Mesylate Ophthalmic Solution 1%

    Mydriasis, Dilation

    Enrollment
    32
    Start
    Aug 2019
    Primary Completion
    Sep 2019
    Completion
    Sep 2019
    NCT04024891
  • Phase 2
    Completed

    Safety and Efficacy of Nyxol With Pilocarpine Eye Drops in Subjects With Presbyopia

    Phentolamine Ophthalmic Solution 0.75%, Pilocarpine

    Presbyopia

    Enrollment
    150
    Start
    Feb 2021
    Primary Completion
    May 2021
    Completion
    Jun 2021
    NCT04675151
  • Phase 2
    Completed

    Study of the Safety and Efficacy of APX3330 in Diabetic Retinopathy

    APX3330, Placebo

    Diabetic Retinopathy, Diabetic Macular Edema +2

    Enrollment
    103
    Start
    Apr 2021
    Primary Completion
    Jan 2023
    Completion
    Jan 2023
    NCT04692688
  • Phase 1/2
    Terminated

    RX-5902 Treatment of Subjects With Triple Negative Breast Cancer

    RX-5902

    Solid Tumor, Triple Negative Breast Cancer

    Enrollment
    18
    Start
    Aug 2013
    Primary Completion
    Oct 2019
    Completion
    Nov 2019
    NCT02003092
  • Phase 1/2
    Terminated

    Dose-Finding, Safety and Efficacy Study of RX-0201 Plus Everolimus in Metastatic Renal Cell Cancer

    RX-0201

    Metastatic Renal Cell Cancer

    Enrollment
    24
    Start
    Aug 2014
    Primary Completion
    Apr 2018
    Completion
    May 2018
    NCT02089334
  • Phase 1/2
    Recruiting

    Safety and Tolerability Subretinal OPGx-001 for LCA5-Associated Inherited Retinal Degeneration (LCA5-IRD) and Non-interventional Arm With Untreated Patients

    AAV8.hLCA5

    LCA5

    Enrollment
    22
    Start
    Jun 2023
    Primary Completion
    Jun 2028est.
    Completion
    Jun 2028est.
    NCT05616793
  • Phase 1/2
    Recruiting

    Safety and Tolerability of Subretinally Injected OPGx-BEST1 in Patients With Best Vitelliform Macular Dystrophy (BVMD) or Autosomal-Recessive Bestrophinopathy (ARB)

    OPGx-BEST1

    ARB, BVMD +2

    Enrollment
    10
    Start
    Sep 2025
    Primary Completion
    Aug 2030est.
    Completion
    Aug 2030est.
    NCT07185256
  • Phase 1/2
    Recruiting

    Safety and Tolerability of Subretinal OPGx-RDH12-1001 for LCA-Associated Inherited Retinal Degeneration (LCA-IRD)

    OPGx-RDH12

    Leber Congenital Amaurosis, Leber Congenital Amaurosis (LCA)

    Enrollment
    10
    Start
    Oct 2026est.
    Primary Completion
    Dec 2032est.
    Completion
    Jul 2034est.
    NCT07681778
Search ClinicalTrials.gov for “Opus Genetics”