Industry News

Presbyopia Eye Drop Approved

The US FDA granted approval to VUITY™ (pilocarpine HCL ophthalmic solution 1.25%, Allergan) for presbyopia treatment. This is the first eye drop approved for this indication. Clinical studies showed that a daily instillation worked in as little as 15 minutes and lasted up to six hours, as measured on day 30. Improvements were seen in near and intermediate vision without affecting distance vision. The drop uses a proprietary pHast™ technology to help rapidly adjust to the physiologic pH of the tear film. The most common treatment-emergent, non-serious adverse events seen in clinical studies were headache and eye redness occurring in less than 5% of patients.

OCULAR IMPLANT FOR WET AMD

Susvimo™ (Genentech, Roche), an ocular implant that delivers ranibizumab (Lucentis) 100 mg/mL, gained US FDA approval for treating wet age-related macular degeneration in patients who have previously responded to at least two anti-vascular endothelial growth factor injections. Susvimo provides up to six months of the active drug between refills. The device is implanted in a quick outpatient procedure.

EXPANDED APPROVAL FOR DEXTENZA

The US FDA has approved a supplemental new drug application for DEXTENZA® (dexamethasone ophthalmic insert, Ocular Therapeutix). The new approval adds ocular itching associated with allergic conjunctivitis to the drug’s current indications. DEXTENZA is an ophthalmic insert placed in the lower lacrimal punctum and into the canaliculus. A single treatment releases a 0.4 mg dose of dexamethasone for up to 30 days following insertion. The device was already approved for treating ocular inflammation and pain following eye surgery.