Depot steroids reduce burden of compliance for patients
Dexycu and Dextenza provide lasting drug delivery postoperatively.
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Welcome to another edition of CEDARS/ASPENS Debates. CEDARS/ASPENS is a joint society of cornea, cataract and refractive surgery specialists, here to discuss some of the latest hot topics in ophthalmology.
The use of postoperative drops continues to burden surgeons and patients due to issues with cost, compliance and efficacy. Fortunately, new methods of drug delivery have been approved and now are starting to change the way surgeons approach postop care.
This month, John A. Hovanesian MD, FACS, and James A. Katz, MD, discuss the use of two new methods of steroid delivery for cataract surgery.
We hope you enjoy the discussion.
Kenneth A. Beckman, MD, FACS
OSN CEDARS/ASPENS Debates Editor
Dexycu delivers anti-inflammatory inside the eye
Both Dexycu (dexamethasone intraocular suspension 9%, EyePoint Pharmaceuticals) and Dextenza (dexamethasone ophthalmic insert 0.4 mg, Ocular Therapeutix) are breakthrough products because this is the first time we have steroids that are designed and approved for postoperative use in a sustained way without eye drops.
A study by An and colleagues that looked at compliance with eye drops in glaucoma patients showed that 92% do not take their drops correctly. We know there is a big problem here.
Dexycu has an advantage of being delivered inside the eye where the anti-inflammatory effect is needed. It does not rely on a patient having normal punctal anatomy to deliver it, and once it is in the eye at the end of surgery, it is a sure thing that it will stay there.
Dextenza has the advantage of benefiting the ocular surface because, while it elutes enough steroid to get inside the eye, it also provides it to the outside of the eye, which means that we have a preservative-free steroid bathing the eye. Other treatments with eye drops are usually toxic to the surface of the eye. Dextenza stays in place 99.5% of the time, according to the FDA study by Tyson and colleagues.
A surgeon might choose Dexycu because he or she is more comfortable with its form factor. It is injected behind the iris, usually in the inferior ciliary sulcus, and we typically recommend doing this as the last step of surgery after the wound is hydrated, viscoelastic is removed and the lens is in good position.
In FDA studies, Dexycu was evaluated in a unique way. It was tested against Pred Forte (prednisolone, Allergan) in a noninferiority study; most steroids are tested against placebo. So, in many ways, Dexycu has the most real-world evidence supporting its use by being compared with and being noninferior to Pred Forte for both pain and inflammation after surgery.
I have used both products extensively. I was involved in both FDA trials, and I have used both of them since approval. Each one applies to different kinds of patients, but both are for situations where we would want to unburden the patient from using steroid drops. There is also a particular advantage when these medicines are paired with Omidria (phenylephrine 1% and ketorolac 0.3% intraocular solution, Omeros). Dexycu or Dextenza combined with Omidria provides lasting delivery of both a steroid and nonsteroidal to the eye.
Eric Donnenfeld, MD, and I are undertaking a clinical study to examine whether these can substitute for both postoperative anti-inflammatory drops. In other words, if patients do well with a depot steroid plus Omidria, we can use an intracameral antibiotic and have a completely dropless postoperative regimen, which would be a big step forward for patients.
Surgeons should learn about these products, choose what they like for appropriate patients and use them.
- References:
- An JA, et al. J Cataract Refract Surg. 2014;doi:10.1016/j.jcrs.2014.02.037.
- Study to evaluate the safety for the treatment of inflammation associated with cataract surgery. clinicaltrials.gov/ct2/show/study/NCT02547623. Updated Aug. 21, 2018. Accessed Nov. 13, 2019.
- Tyson S, et al. Management of ocular inflammation and pain following cataract surgery with Dextenza, dexamethasone insert (0.4 mg): pooled analysis of three phase 3 studies. Presented at: American Society of Cataract and Refractive Surgery annual meeting; May 6, 2019; San Diego.
- For more information:
- John A. Hovanesian, MD, FACS, can be reached at Harvard Eye Associates, 24401 Calle De La Louisa, Laguna Hills, CA 92653; email: drhovanesian@harvardeye.com.
Disclosure: Hovanesian reports he is a consultant to Alcon, Allergan, Bausch + Lomb, EyePoint, Novartis and Ocular Therapeutix.
Dextenza is reversible
Dextenza (dexamethasone ophthalmic insert 0.4 mg, Ocular Therapeutix) is a preservative-free insert placed in the punctum after ophthalmic surgery. It expands and form fits upon contact with moisture, and it becomes secure in the lacrimal canaliculus. Dextenza is designed to provide a tapered dose of dexamethasone for up to a month with one insert. Over that 1-month period of time, it breaks down through hydrolysis. Dextenza also contains fluorescein, which is used for visualizing the insert to monitor retention.
Surgeons use Dextenza, as well as Dexycu (dexamethasone intraocular suspension 9%, EyePoint Pharmaceuticals), out of convenience and to reduce the burden of compliance for the patient. It is a method of drug delivery that provides consistent dosing unrelated to patient compliance.
As a cornea specialist, I like that it is preservative free. It is much gentler on the corneal surface, possibly reducing dry eye symptoms or irritation due to the lack of preservative and the fact that you are blocking the drainage system and allowing more fluid to stay on the eye, similar to a temporary punctal plug. It is an advantage to the patient to have his or her own natural tears on the eye and the lack of preservatives.
The studies showed good efficacy for the reduction of pain as well as anterior chamber cell at 2 weeks in a high percentage of patients, according to Tyson and colleagues. That is important for our patients because they do not have to do anything. They do not have to remember to put those drops in to get the efficacy and reduction of pain and anterior chamber cell.
Dextenza is easy to insert, according to Walters and colleagues and Tyson and colleagues, is convenient and does not increase workflow; it does not take long to place in the eye. It is absorbable, so there is no need for removal.
It is approved by the FDA for patients undergoing ocular surgery and not just cataract surgery, which is nice. However, in the U.S., we do a large volume of cataract surgery, and any way we have to reduce the burden of drops or placement of medicine that may eliminate compliance issues is welcome to surgeons as well as patients.
We consider Dextenza’s use and discuss it with any patient who is eligible for it under their insurance plan. This is changing over time, as more patients become eligible.
There are no ophthalmic surgery patients in whom I would avoid using this insert, including potential steroid responders or patients with glaucoma. The reason for this is twofold. For one, the level of pressure spikes in a study was only 0.2%, which is extremely low, according to Tyson and colleagues. For the other, if necessary, the insert is easy to remove through manual expression or through the nasolacrimal system. It is reversible if the product does cause a side effect, which I think is a big plus. That contrasts with other medications or other drug delivery systems.
Both products reduce the need for drops, but Dextenza can be removed. Another benefit is there may be a possibility in the future to place the insert postoperatively in the office, which makes it completely different. Right now it is more of an issue of coding, billing and workflow.
Dextenza’s benefits are its efficacy, convenience for the patient, ease of use for the physician as well as expanded coverage for the patient. In addition, the lack of preservative and potential for less irritation in dry eye patients is quite welcome during their recovery and healing from ophthalmic surgery.
- References:
- Tyson S, et al. Management of ocular inflammation and pain following cataract surgery with Dextenza, dexamethasone insert (0.4 mg): pooled analysis of three phase 3 studies. Presented at: American Society of Cataract and Refractive Surgery annual meeting; May 6, 2019; San Diego.
- Tyson SL, et al. J Cataract Refract Surg. 2019;doi:10.1016/j.jcrs.2018.09.023.
- Walters T, et al. J Clin Exp Ophthalmol. 2016;doi:10.4172/2155-9570.1000572.
- For more information:
- James A. Katz, MD, can be reached at Midwest Center for Sight, 8901 West Golf Road, Suite 300, Des Plaines, IL 60016; email: jamesakatz@gmail.com.
Disclosure: Katz reports he is a consultant to Ocular Therapeutix and EyePoint Pharmaceuticals.