Summary:
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This is a multicenter, open-label, dose escalation (Cohort 1) to masked, randomized, parallel-groups (Cohort 2) and (Cohort 3) study to evaluate the safety and efficacy of AGN-193408 SR in participants with open-angle glaucoma or ocular hypertension.
Criteria:
- Diagnosis of either OAG (ie, POAG, pseudoexfoliation glaucoma, pigmentary glaucoma) or OHT in both eyes. (Note: diagnosis does not have to be the same in both eyes)
- Both eyes can be treated adequately with topical prostamide, prostaglandin, or prostaglandin analog (eg, LUMIGAN, Xalatan,Travatan) eye drops as the sole therapy if medication was taken as directed
- Shaffer Grade ≥ 3 on clinical gonioscopy of the inferior angle
- Peripheral anterior chamber depth by Van Herick examination ≥ ½ corneal thickness
- Central endothelial cell density ≥ 2000 cells/mm2 in the study eye by specular microscopy confirmed as being qualified by Reading Center assessment prior to beginning Washout
- Central endothelial cell density ≥ 1800 cells/mm2 in the fellow eye by specular microscopy confirmed as being qualified by Reading Center assessment prior to beginning Washout
- At the Screening and Baseline visits: Best-corrected visual acuity (BCVA
- Snellen equivalent, by manifest refraction) of 20/50 or better in the study eye and the fellow eye
- Must be pseudophakic (at least 4 months postcataract surgery prior to treatment administration [Cycle 1 Day 1 Administration visit]) in the study eye
- No pregnancy
- No history of intracameral implant in the study eye (eg, Bimatoprost SR, OTX-TIC)
- No history of laser trabeculoplasty within 6 months prior to screening in the study eye
- No history of Intraocular surgery (including cataract surgery) in the study eye within the 4 months prior to treatment administration (Cycle 1 Day 1 Administration visit)
- No history of corneal graft, including partial grafts or incisional refractive surgery other than astigmatic keratotomy or limbal relaxing incisions in the study eye
- No active ocular disease in either eye (eg, uveitis, ocular infection, chronic moderate to severe blepharitis or severe dry eye, ocular seasonal allergies) or sight threatening diseases (eg, neovascular age-related macular degeneration [AMD], diabetic macular edema)
- No Anticipated need for any incisional or laser ocular surgery in either eye during the study
- No PAS in the inferior iridocorneal angle on gonioscopic examination at Screening in the study eye
All participants must provide informed consent prior to beginning any drug washout for the purposes of inclusion in this study; Participants currently being treated with IOP-lowering medication( arasympathomimetics (eg, PILAGAN®, Carbachol, Pilocar®): 4 days, Carbonic Anhydrase Inhibitors (topical or systemic) (eg, Diamox®, Trusopt®, Azopt®): 4 days, Sympathomimetics (eg, PROPINE®, Epifrin®): 14 days, Alpha-agonists (eg, ALPHAGAN P, Iopidine®): 14 days, Beta-adrenergic blocking agents (eg, Timoptic®, BETAGAN®, Betoptic® Betoptic-S®, Opti-Pranolol®, Ocupress®, Timoptic XE®): 28 days, Rho-kinase inhibitors (eg, Rhopressa®, Glanatec®): 28 days, Prostamides, prostaglandins and prostaglandin analogues, as well as combination products that include these medications (eg, LUMIGAN, Xalatan, Travatan, Rescula®, GANFORT®): 28 days, Combination therapy (for example, COMBIGAN® [28 days], Cosopt® [28 days], GANFORT® [28 days], Simbrinza® [14 days], Azarga® [28 days], Roclatan® [28 days], etc) Longest minimum duration of any component based on medication class) in either eye will begin washout of these medication(s) following completion of the screening procedures and after reading center qualification of endothelial cell density per inclusion criteria; The screening and reading center qualification may not be concurrent with the washout period. The washout period will be up to 56 days depending on the minimum washout period schedule below.
Qualified Participants May Receive:
Up to $2,300 over study lifetime assuming all visits are attended