Two drugs announced positive phase three results last week.

1.  Dextenza – some results were released back in November (20/20 Glance recap here) but they recently announced they also met their secondary endpoint.
What is Dextenza?
It’s a dexamethasone insert, placed through the punctum into the canaliculus and is designed to deliver dexamethasone to the ocular surface for up to 30 days. Following treatment, Dextenza resorbs and exits the nasolacrimal system without need for removal.
The trial investigated Dextenza for the treatment of post-surgical ocular inflammation and pain. Over 400 patients underwent cataract surgery and received either Dextenza or a placebo vehicle.   Primary endpoints were met:  absence of ocular pain on day 8 and absence of ocular inflammation on day 14 when compared to placebo.  And the secondary endpoint, the absence of anterior chamber flare, was statistically superior to the placebo group.

2. Seciera – a formulation of cyclosporine for the treatment of dry eye syndrome.
Wait, isn’t Restasis cyclosporine too?
It is, but Seciera has a different delivery method.  It’s still a drop dosed BID but it uses a “nanomicellar formulation” of cyclosporine.  Nanomicelles are tiny particles comprised of a hydrophobic core surrounded by a hydrophilic shell.  The theory is that they increase bioavailability and improve penetration of the drug.  Results released showed Seciera met the primary endpoint (improvement in Schirmer score) and secondary end points (improvement in symptoms, conjunctival and corneal staining scores) at 12 weeks.

Both drugs plan to submit a new drug application to the FDA, however the review process can take 6-12 months.