These Recent FDA Approvals Will Re-Shape Optometry
By: Paul M. Karpecki, OD, FAAO
Clinical Director – PECAA
It is hard to believe that in the last 60 days we’ve had so many key technology, drug approval and NDA’s (New Drug Applications) accepted. Knowing about these will give you an edge in managing your patients.
What a way to launch 2018 with the approval of not one, but two novel drugs for the management of glaucoma. It’s been two decades since a new drug treatment was available and we get two approved in late 2017. Bausch + Lomb’s Vyzulta, with the addition of a nitric oxide donor has been shown to increase aqueous outflow by working directly on the trabecular meshwork (TM) and may have neuroprotective properties. In the pivotal trial, this drug has been shown to lower pressure by an average of over 9mmHg, which is the most observed to date in a glaucoma FDA trial. The second is Rhopressa or netarsudil ophthalmic solution 0.02% from Aerie Pharmaceuticals. Rhopressa, a RhoKinase inhibitor, is indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension working directly on the trabecular meshwork (TM) to increase aqueous outflow as well as two other mechanisms of action (decreased aqueous production and inhibiting episcleral venous pressure). It is a true new class medication and appears to be ideal as a secondary treatment or in cases of normal tension glaucoma.
Dry Eye Disease
TearFilm Innovations received FDA approval for their iLux system that allows doctors to treat MGD with a hand held device using infrared that warms the eyelids to the appropriate temperature. It then allows for manual expression with the unit while watching through a magnified view the meibomian glands. Also in early January, the U.S. FDA accepted a New Drug Application from Sun Pharmaceutical’s for cyclosporine A, ophthalmic solution 0.09% called OTX-101. This is a higher concentration than any product on the market and uses a unique nanomicellar formulation of cyclosporine. It is a clear solution and comes in preservative-free vials. In a 12-week, multicenter, randomized, double-masked, vehicle-controlled Phase III study, 744 patients with dry eye were treated either with OTX-101 or its vehicle. After 12 weeks of treatment, OTX-101 showed statistically significant improvement in the primary endpoint, Schirmer’s score (p<0.0001). That is a highly statistically significant improvement over the vehicle.
Eye Redness Remover
A very exciting newly approved over the counter (OTC) product called LUMIFY was approved in late December. Unlike vasoconstrictors to get the red out like Visine, Lumify has no rebound hyperemia or tachyphylaxis (loss of efficacy over time). The product is low dose brimonidine and thus we’ve had over 20 years experience with the much higher doses shown to be safe. Patients with eye redness and irritation can experience negative social connotations which can impact daily life. The issue with previous drops that removed redness included rebound hyperemia or tachy-phylaxis which can lead to overuse and potential corneal toxicity.
This newly approved technology may put optometry in the true quarterback position for managing patients with cataracts. Last month we saw the approval of RxSight’s light adjustable intraocular lens (IOL). Imagine having the option of putting in an IOL without the concern of final refractive error, for about the cost of a standard IOL.The only difference is that this one can be adjusted for up to 4 weeks after it has been implanted. What this does is place optometry as the key doctor in determining what, if any, prescription change is required post cataract surgery. With a uv light laser any residual refractive error can be corrected or you could try contact lenses or trial lenses to determine if a patient would be better suited for monovision, if the astigmatism should be corrected or not etc. The company is currently working with FDA on the post approval process, building infrastructure and will announce commercial plans later this year.
These new approvals will be significant for our profession and our patients. As PECAA Members, the ability to stay in front of these approvals and technologies will set you apart.