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Microinvasive medical therapies needed for glaucoma patients
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This is an interesting time in glaucoma. The field is attracting financial investment, and many of our best young ophthalmologists are seeking glaucoma fellowships. We have several new medical and surgical treatments for the glaucoma patient. This is all good news.
One major unmet need remains the unfortunate fact that as many as 50% of patients with glaucoma are undiagnosed. To date, there is no solution to that problem other than to encourage all citizens, as the American Academy of Ophthalmology has done, to have a screening eye examination at age 40 years followed by regular examinations thereafter. Even with only 50% diagnosed, we have about 3 million glaucoma patients being treated in the United States and nearly 70 million in the world. That is a lot of eyes requiring treatment. In some parts of the world, medical therapy dominates, and in other parts of the world, usually where medical therapy is unavailable or impractical, glaucoma is a surgical disease. The cover story in this issue of Ocular Surgery News focuses on medical therapy.
For primary open-angle glaucoma in the U.S., we have several effective topical medications that are also reasonably priced. Latanoprost is an effective drop given once daily and costs less than $15 per month per eye. So for the usual bilateral disease, a patient can be treated for $360 per year. To me, the generic dorzolamide/timolol is an attractively priced second agent. Using this drop twice daily costs about $20 per month, or $240 per year. So with a two-bottle/three-medication therapy using readily available generics, we have in the U.S. a $600 per year cost, or $50 per month, or $1.67 per day. Some compounding pharmacies, including Imprimis, will meet this price with a nonpreserved agent. In my opinion, $600 per year is a pretty reasonable price to treat a potentially blinding disease.
This is the competition that a new branded drug faces when it launches into the U.S. market. Vyzulta (latanoprostene bunod ophthalmic solution 0.024%), the new Bausch + Lomb product, is priced near $390 per 5 mL bottle, according to GoodRx.com. This should be enough drops to treat both eyes for a month but still translates to $4,680 per year, or $12.82 per day. To justify its use, either its safety or efficacy, or both, needs to be significantly superior to the generic option. Of course, our confusing and multilayered pharmacy environment with different insurance companies, different co-pays, the impact of manufacturer coupons and the potential lack of drug availability at the various pharmacies with the annoying callbacks will play a major role in the success of Vyzulta and Rhopressa (netarsudil ophthalmic solution 0.02%, Aerie Pharmaceuticals) as they launch commercially.
Still, as I stated earlier, the current generics will be tough competition. After diagnosing the undiagnosed glaucoma patient, the next biggest challenge to overcome in medical therapy is the issue of patient noncompliance. The most pessimistic studies suggest that by 4 years, only 15% of patients are “compliant” with the recommended therapy, and even the most motivated patients miss a few drops. Safe and effective drops, regardless of cost, do not work if they are not taken and taken properly by the patient.
We have several approved microinvasive glaucoma surgeries approved. We need several microinvasive medical therapies that do not rely on patient compliance. The most promising externally placed options, to me, are medication-releasing punctal plugs, conjunctival rings and conjunctival inserts. Also promising are several devices or pellets that can be implanted into the anterior chamber, which will require an office-based procedure similar to an anti-VEGF injection for exudative age-related macular degeneration. This is within the reach of most ophthalmologists, and intracameral medication delivery appears to be even more effective than topical application.
The glaucoma market is large, growing and global, so we can expect it to attract significant investment of human and financial capital, fertilizing a robust and diverse set of innovations. Some will be medical, some will be surgical, and some will be a combination of the two. Critical to the future best interests of our patients is to develop a way to diagnose the undiagnosed glaucoma patient and then treat all victims of this potentially blinding disease in a cost-effective fashion that does not require the patients’ compliant participation. Neither of these is an easy goal to achieve, but incremental progress is being made toward both of these challenges.
Disclosure: Lindstrom reports he has a financial interest in Imprimis, Ocular Therapeutix and ForSight Vision5 and is a consultant for Bausch + Lomb, Novartis, Allergan and Imprimis.