There have been a few new product launches; let's review.
Systane iLux 2.
Alcon has introduced the Systane iLux2 Meibomian Gland Dysfunction (MGD) Thermal Pulsation System.
The handheld device uses new technology that allows patients to view their meibomian glands through infrared imaging and their treatment through infrared HD video of the procedure. (via)
iCare Home2 Self tonometer.
ICare USA announced 510(k) clearance from the FDA for its next-generation self-tonometer, the iCare HOME2. iCare CLINIC cloud-based software stores IOP data measured by the tonometer. The reports provide health care professionals an in-depth overview of changes in patients’ IOP status.
Second-generation iTear 100.
Olympic Ophthalmics announced that the FDA has granted 510(K) clearance for its second-generation iTear100 device, a prescription neuromodulation therapy designed to acutely increase tear production without contact in adults over a 30-day period.
iTear100 is a non-chemical connected device that offers telehealth tools, including prescription download capability and activation through a mobile phone app. It is the only prescription medical device for home use that can increase natural tear production in all adult patients.
Vuity dosing may change in the future.
Allergan announced that the phase 3 VIRGO trial evaluating the safety and efficacy of investigational twice-daily administration of Vuity (pilocarpine HCl ophthalmic solution) 1.25% in adults with presbyopia met its primary efficacy endpoint of improving near vision without compromising distance vision at hour 9 (3 hours after the second drop) on day 14.
The twice-daily use of Vuity is not approved and its safety and efficacy have not been evaluated by the FDA. (via)