LATANOPROSTENE BUNOD

AbsorptionThe systemic exposure of latanoprostene bunod and its metabolites latanoprost acid and butanediol mononitrate were evaluated in one study with 22 healthy subjects after topical ocular administration of latanoprostene bunod ophthalmic solution, 0.024% once daily (one drop bilaterally in the morning) for 28 days. There were no quantifiable plasma concentrations of latanoprostene bunod (lower limit of quantitation, LLOQ, of 10.0 pg/mL) or butanediol mononitrate (LLOQ of 200 pg/mL) post-d...

In clinical studies up to 12 months duration, patients with open-angle glaucoma or ocular hypertension with average baseline intraocular pressures (IOPs) of 26.7 mmHg, the IOP-lowering effect of latanoprostene bunod ophthalmic solution, 0.024% once daily (in the evening) was up to 7 to 9 mmHg.

The following adverse reactions are described elsewhere in the labeling:

• Pigmentation [see Warnings and Precautions (5.1) ]
• Eyelash Changes [see Warnings and Precautions (5.2) ]
• Intraocular Inflammation [see Warnings and Precautions (5.3) ]
• Macular Edema [see Warnings and Precautions (5.4) ]
• Bacterial Keratitis [see Warnings and Precautions (5.5) ]
• Use with Contact Lens [see Warnings and Precautions (5.6 )] Most common ocular adverse reactions with incidence ≥ 2% are conjunctiv...

None. None.

• Pigmentation: Increased pigmentation of the iris and periorbital tissue (eyelid) can occur. Iris pigmentation is likely to be permanent. ( 5.1 )
• Eyelash changes: Gradual changes to eyelashes including increased length, increased thickness and number of eyelashes. Usually reversible upon discontinuation of treatment. ( 5.2 ) 5.1 Pigmentation Latanoprostene bunod ophthalmic solution, 0.024% may cause changes to pigmented tissues. The most frequently reported changes with prostaglandin analogs ...