REGN22530 for Adults With Primary Open Angle Glaucoma or Ocular Hypertension (BAHAMA)

A Phase 1/2 Study of REGN22530 in Participants With Primary Open Angle Glaucoma or Ocular Hypertension

This study will test an experimental drug called REGN22530 ("study drug") to see if it can help treat people with primary open angle glaucoma or ocular hypertension. REGN22530 is an experimental drug that is designed to bind with a protein in the eye that has been shown to cause a buildup of fluid inside the eye and cause increased Intraocular Pressure (IOP).

REGN22530 attaches to this protein and stops it from working which may allow more fluid to drain out of the eye and decrease the pressure.

The study is looking at:

• What side effects REGN22530 might cause
• How much REGN22530 is in the blood and eye fluid at different times
• If the body has any reactions to REGN22530 (which may cause REGN22530 to not work as well)
• How the body and eye pressure respond after having REGN22530, which can help researchers understand why REGN22530 works better in some people than others
• How well REGN22530 works

Study Overview

• Status: Not yet recruiting
• Conditions: Primary Open Angle Glaucoma (POAG); Ocular Hypertension (OHT)
• Intervention / Treatment: Drug: REGN22530

• Study Type: Interventional
• Enrollment (Estimated): 271
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Clinical Trials Administrator; Phone Number: 844-734-6643; Email: clinicaltrials@regeneron.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Key Inclusion Criteria:

1. Diagnosis of OHT or POAG of mild to moderate severity as described in the protocol
2. Best-Corrected Visual Acuity (BCVA) of ≥35 Early Treatment Diabetic Retinopathy Study (ETDRS) letters (Snellen equivalent of better than or equal to 20/200) in the study eye on day 1
3. BCVA of ≥55 EDTRS letters (Snellen equivalent of better than or equal to 20/80) in the non-study eye on day 1
4. Phakic or pseudophakic with a posterior chamber intraocular lens that has been implanted ≥3 months prior to Screening Visit 1
5. Sufficiently clear ocular media, adequate pupillary dilation and fixation to permit quality posterior segment imaging in the study eye

Key Exclusion Criteria:

Ocular-specific exclusion criteria apply to the Study Eye only, unless otherwise specified.

1. OAG or OHT secondary to pigment dispersion, pseudoexfoliation, trauma, uveitis, neovascularization, a vascular disorder, or steroid use
2. Congenital or traumatic cataract, or visually significant cataract that is likely to require surgical intervention during the study
3. Presence of significant corneal scarring or irregularities that could interfere with reliable IOP measurement
4. Prior incisional or bleb-forming glaucoma surgery, suprachoroidal procedures, Trabecular Meshwork (TM)-stripping Microinvasive Glaucoma Surgery (MIGS), angle-based implants other than iStent or iridectomy/iridotomy as described in the protocol
5. History of Selective Laser Trabeculoplasty (SLT) within 6 months prior to day 1
6. History of transscleral (including micropulse) or endoscopic cyclophotocoagulation within 1 year prior to day 1

Note: Other protocol defined Inclusion/ Exclusion criteria apply

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Phase 1 Part A	Drug: REGN22530; Administered per the protocol
Experimental: Phase 1 Part B	Drug: REGN22530; Administered per the protocol
Experimental: Phase 2 Part C	Drug: REGN22530; Administered per the protocol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Occurrence of Treatment Emergent Adverse Events (TEAEs)	Part A and B	Up to week 16
Change from baseline in mean diurnal IOP in the study eye	Part C	At day 85

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Concentrations of REGN22530 in serum		Up to week 24
Occurrence of Anti-Drug Antibodies (ADAs) to REGN22530 in serum		Up to week 24
Magnitude of ADAs to REGN22530 in serum		Up to week 24
Occurrence of TEAEs	Part C	Up to week 24

Collaborators and Investigators

• Sponsor: Regeneron Pharmaceuticals
• Investigators: Study Director: Clinical Trial Management, Regeneron Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Estimated): July 23, 2026
• Primary Completion (Estimated): July 25, 2029
• Study Completion (Estimated): October 16, 2029

Study Registration Dates

• First Submitted: June 23, 2026
• First Submitted That Met QC Criteria: June 23, 2026
• First Posted (Actual): June 30, 2026

Study Record Updates

• Last Update Posted (Actual): June 30, 2026
• Last Update Submitted That Met QC Criteria: June 23, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: First in Human (FIH); Intraocular Pressure (IOP); Open Angle Glaucoma (OAG)
• Additional Relevant MeSH Terms: Eye Diseases; Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension
• Other Study ID Numbers: R22530-IOP-2558; 2026-526004-76-00 (Ctis)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing

IPD Sharing Time Frame

When Regeneron has:

• received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication or has globally discontinued development of the product for all indications on or after April 2020 and has no plans for future development
• made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry)
• the legal authority to share the data, and
• ensured the ability to protect participant privacy

• IPD Sharing Access Criteria: Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No