Eysuvis (Loteprednol 0.25%)

Common Side Effects

Instillation site pain, 5%: The most common adverse reaction in the clinical trials after 2 weeks of use, and the only one the label quantifies.
Pooled trial safety, 4 trials: Across 1 phase 2 and 3 phase 3 vehicle-controlled trials dosed QID for 2 to 4 weeks (1430 on drug, 1438 on vehicle), instillation site pain occurred in 5.2% versus 4.4% and every other adverse event in 0.8% or fewer; an IOP rise of more than 5 mmHg from baseline reaching 21 mmHg or higher occurred in 0.6% versus 0.2%, in trials that excluded patients with current or prior glaucoma.
Corticosteroid class effects: Elevated IOP with infrequent optic nerve damage and visual acuity and field defects, posterior subcapsular cataract formation, delayed wound healing, secondary ocular infection from pathogens including herpes simplex, and perforation of the globe where the cornea or sclera is thinned.

Pregnancy & Lactation

Pregnancy: No adequate and well controlled studies in pregnant women, and teratogenicity occurred at clinically relevant doses in rabbits and rats given the drug orally during pregnancy. Oral dosing in pregnant rabbits produced fetal malformations at 1.4 times the recommended human ophthalmic dose (spina bifida including meningocele), exencephaly and craniofacial malformations at 5.6 times, and abortion and embryofetal lethality at 83 times, with no developmental no-adverse-effect level established. Oral dosing in pregnant rats produced malformations at 34 times and embryofetal lethality at 695 times, with a developmental no-adverse-effect level of 3.4 times; in rats dosed from late gestation through lactation, survival of live-born offspring was reduced at 3.4 times. Background U.S. population risk is 2% to 4% for major birth defects and 15% to 20% for miscarriage.

Lactation: No data on presence in human milk, effects on the breastfed infant, or effects on milk production; weigh the developmental and health benefits of breastfeeding against the clinical need for treatment.

Eysuvis (Loteprednol 0.25%) | EyeKnow O.D.