By: Paul M. Karpecki, OD, FAAO Clinical Director – PECAA
I have to credit the FDA as we’ve seen more approvals for ocular drugs and devices than at any time I can recall in the past. In the last 30 days we had a new drug approved for dry eye disease, a low dose corticosteroid, a drug for neurotrophic keratitis and what might be the most effective MIGs procedure to date. It’s so important that we as clinicians stay on top of the latest developments available to our patients. We’ll cover two this month and two more next month (unless there are more approvals!)
CEQUA for Dry Eye Disease
Cequa from Sun pharmaceuticals is 0.09% cyclosporine A (CsA) housed in a nanomicellular matrix dosed at BID. Recall that Restasis is cyclosporine 0.05% so this is significant increase in concentration. Nanomicellular refers to polymers composed of a hydrophobic (water-insoluble) core that entraps lipophilic drugs like CsA, surrounded by a hydrophilic (water-soluble) outer shell. Cequa nanomicellar formulation of cyclosporine:
It has been shown that these water-soluble micelles help increase drug dispersion and bioavailability (Kaido Cornea 2011).
In the pivotal phase III clinical trial, Cequa led to greater overall improvements in corneal staining compared to the vehicle, as early as 4 weeks, and maintained through 12 weeks. It was also very well tolerated. What was most impressive to me was that complete clearance of central corneal staining, something that most drugs (other than corticosteroids) have difficulty achieving, was statistically superior to the vehicle as soon as 4 weeks. And with that, visual acuity was also significantly improved from baseline and when compared to the vehicle. There was no statistical difference between Cequa and the vehicle when symptoms were measured at 12 weeks but it trended positively.
Total Corneal Staining
Central Corneal Staining
MIGS Gets It’s Best Technology Yet: Ivantis Hydrus Microstent
Microincisional glaucoma surgery (MIGS) has actually been around for a few years. It’s a procedure for patients with glaucoma where a stent can be inserted in Schlemm’s canal at the time of cataract surgery to increase aqueous outflow. Currently in the U.S., you have only one opportunity for a patient to have this technology, and that’s at the time of cataract surgery- so you don’t want to miss that one window of opportunity for glaucoma patients. Approximately 20% of patients going into cataract surgery have glaucoma so it’s a significant percentage. The Hydrus Microstent is a flexible, biocompatible 8mm stent. It is contoured to match the curvature of the Schlemm’s canal. There are three open windows that face the anterior chamber allowing for greater aqueous outflow.
The Hydrus had the most significant IOP lowering effect of any MIGS device in an FDA phase III data presented to date (although these are not head to head studies, but rather independent studies). The graph below shows that about 80% of patients in the pivotal clinical trial, were medication free for 24 months, compared to the group that just had cataract surgery alone at about 48%. Recall that removing a patient’s cataracts usually results in a drop in IOP.
This was the largest percentage of patients off medication of any phase III study to date involving a MIGS device and is 30% higher than patients not receiving a stent.
So these are two very exciting FDA approvals that happened in the last 30 days. It’s important to be aware of what is available for your patients. Patients appreciate your knowledge and access to what might be best for them. Staying on top of the latest developments will likely help grow your practice as well.