ROCKLATAN

AbsorptionThe systemic exposures of netarsudil and its active metabolite, AR-13503, were evaluated in 18 healthy subjects after topical ocular administration of netarsudil ophthalmic solution 0.02% once daily (1 drop bilaterally in the morning) for 8 days. There were no quantifiable plasma concentrations of netarsudil (lower limit of quantitation (LLOQ) 0.100 ng/mL) post dose on Day 1 and Day 8. Only 1 plasma concentration at 0.11 ng/mL for the active metabolite was observed for 1 subject on Da...

ROCKLATAN (netarsudil and latanoprost ophthalmic solution) 0.02%/0.005% was evaluated in 2 randomized and controlled clinical trials, namely PG324-CS301 (NCT 02558400, referred to as Study 301) and PG324-CS302 (NCT 02674854, referred to as Study 302) in patients with open-angle glaucoma and ocular hypertension. Studies 301 and 302 enrolled subjects with IOP < 36 mmHg and compared IOP lowering effect of ROCKLATAN dosed once daily to individually administered netarsudil 0.02% once daily and latanoprost 0.005% once daily. The treatment duration was 12 months for Study 301 and 3 months for Study 3...

The most common adverse reaction is conjunctival hyperemia (59%). Other common adverse reactions were: instillation site pain (20%), corneal verticillata (15%), and conjunctival hemorrhage (11%). ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Alcon Laboratories, Inc. at 1 800 757 9195, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trial...

None. None. ( 4 )

• Pigmentation : Pigmentation of the iris, periorbital tissue (eyelid) and eyelashes can occur. Iris pigmentation likely to be permanent. ( 5.2 )
• Eyelash Changes : Gradual change to eyelashes including increased length, thickness and number of lashes. Usually reversible. ( 5.3 ) 5.1 Epithelial Corneal Edema ROCKLATAN contains netarsudil which has been associated with Epithelial corneal edema, described as honeycomb or bullous, and has been reported in some patients with pre-existing corneal st...

7. DRUG INTERACTIONS In vitro drug interaction studies have shown that precipitation can occur when eye drops containing thimerosal are mixed with ROCKLATAN. If such drugs are used, they should be administered at least five (5) minutes apart. The combined use of two or more prostaglandins or prostaglandin analogs including latanoprost ophthalmic solution 0.005% is not recommended. It has been show...