I like the term surgical “privileges,” as it implies something you’ve earned, received and should maintain with pride and dedication. Fortunately, optometry has some of the highest success rates when it comes to scope surgical privileges and is the dominant prescriber for the most recently approved medications. I’m not surprised, as we take these privileges seriously by maintaining copious hours of education and hands-on training, and know historically what it was like when we were unable to serve these patients, especially in rural areas.
Currently, 17 states have surgical privileges ranging from lasers like SLT and YAG to drug delivery technologies, removal of non-cancerous lumps and bumps and various minor procedures. All 50 states allow for prescribing oral and topical therapeutics related to ocular disease. Those who use full-scope optometry indeed do well and have great experience, but there is a significant percentage that have not provided the care to patients they are entitled to via prescribing topical agents, including recent FDA-approved medications or providing minor ocular surgeries.
Sometimes, the problem is not being able to join medical panels or knowing how to manage vision plans with health insurance, but there are companies like Optometric Medical Solutions that handle all of this, including credentialing, education and billing/coding for optometric practices. Not getting involved in prescribing medications or performing surgery in states that allow it is like having a full buffet available and choosing to eat crackers.
FDA Approvals
Optometry is responsible for about 70% of the prescriptions for recent drug approvals, and in the last few months, we’ve seen five new medications become available. One of them is Xdemvy (lotilaner ophthalmic, Tarsus Pharmaceuticals) to treat Demodex blepharitis, which is instilled in the eye BID for six weeks to eradicate the mites. Based on the Phase III trials, it is expected that over two-thirds of patients will be collarette-free a year later, even with it being a one-time treatment. About 10% of patients mention burning upon instillation.
The fastest uptake of a new ocular drug is Miebo (perfluorohexyloctane ophthalmic, Bausch + Lomb), with over 100,000 prescriptions in less than two months since its launch in September. Part of the success may be its comfort combined with efficacy in preventing evaporation, which is four times better than healthy human meibum. It is dosed up to QID. The most common side effect observed was a slight transient blur upon instillation; make sure to educate patients about this possibility.
As vast as ocular surface disease is, presbyopia dwarfs it. But the first launch of a drug in this class had reasons for not reaching its potential, including a higher concentration of pilocarpine, which could have lead to side effects like dimming of vision, headache and burning upon instillation.
The latest FDA approval came this past month—Qlosi (“cloh-see”) (pilocarpine hydrochloride ophthalmic, Orasis Pharmaceuticals)—although it won’t launch until 2024. Qlosi has many differentiating factors. First, at 0.4% it is one-third of the concentration of Vuity (pilocarpine 1.25%, Allergan). This alone may help in minimizing side effects and potential complications. It launches at BID dosing, where patients start one drop then add the second two to four hours later, and clinical data shows a consistent eight-hour effect.1 Other unique aspects of Qlosi include being preservative-free, a near neutral pH—which has been an issue prior for pilocarpine—and it contains unique moisturizers.
Although there are no head-to-head studies, it appears to have longer duration, greater comfort and less adverse events based on the PI data. We’ve also learned a lot from the first pilocarpine medication, such as not treating high myopes and expecting a more accurate six to 10 hours of effect with BID dosing. We can also set expectations more accurately. I believe this new drop can reinvigorate a large population base looking for presbyopia solutions.
The high volume prescribing of optometry combined with an incredible number of new and improved medications makes it an ideal time for all 50 states to treat presbyopia patients, as well as those with ocular surface diseases like Demodex blepharitis and dry eye.
Dr. Karpecki is medical director for Keplr Vision and the Dry Eye Institutes of Kentucky and Indiana. He is the Chief Clinical Editor for Review of Optometry and chair of the New Technologies & Treatments conferences. A fixture in optometric clinical education, he consults for a wide array of ophthalmic clients, including ones discussed in this article. Dr. Karpecki's full list of disclosures can be found here.
1. Dunbar M, Koetting C, Karpecki PM. CSF-1 (0.4% pilocarpine HCl ophthalmic solution) for presbyopia: primary and secondary endpoints of the NEAR-1 and NEAR-2 phase 3 clinical trials. American Academy of Optometry. October 11, 2023. |