Innovations in sustained-delivery options: Focus on postoperative treatment
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This two-part series reviews innovative sustained-delivery options for both long- and short-term indications.
Here, in part 2, I cover corticosteroid formulations and implants designed for postoperative use. In part 1, I reviewed longer-acting implants for chronic conditions.
Postoperative inflammation is a natural consequence of vitreoretinal surgery and is often controlled with topical corticosteroids. Patients prescribed corticosteroid drops after ocular surgery often have difficulty adhering to the regimen. They do not get the prescription filled, forget to administer the drops as prescribed, or have physical difficulty doing so. With the advent of sustained-release drug delivery systems, however, we are beginning to see more manageable postoperative treatment regimens, which, in turn, result in better patient adherence and improved outcomes.
Dexycu
Dexycu (dexamethasone intraocular suspension 9%, EyePoint Pharmaceuticals) takes postoperative corticosteroid treatment off the patient’s hands. Dexycu, which is injected at the end of surgery, releases dexamethasone for the first few postoperative weeks to treat inflammation from within the eye.
Dexycu is approved for use after any ocular surgery but was evaluated in patients undergoing cataract surgery. Sixty-six percent of Dexycu-treated eyes achieved anterior chamber cell (ACC) clearing at postoperative day 8 compared with 25% in the placebo group. Adverse events reported more with Dexycu than placebo up to day 90 included IOP increase of 10 mm Hg or more (29% vs. 13%) and dry eye (3.8% vs. 0%).
At my center, I performed a retrospective case-matched comparison, looking at patients who underwent initial pars plana vitrectomy and received either an injection of Dexycu at the time of their procedure or self-administered generic topical prednisolone acetate for 4 weeks. At postoperative day 7, 67% of eyes in the Dexycu group had ACC clearing compared with 37% of eyes in the topical steroid group. The difference in ACC clearing was significant between Dexycu and prednisolone groups at days 1 and 7 (P < .05). Up to 90 days, no serious adverse events were seen with either treatment, and rates of IOP elevation were similar in the two groups. Among phakic eyes, cataract progression was more common in the prednisolone group than the Dexycu group (75% vs. 33%).
Dextenza
Another sustained-release formulation of dexamethasone has been approved for postoperative use in the form of a punctal plug, Dextenza (dexamethasone ophthalmic implant 0.4 mg, Ocular Therapeutix). Like Dexycu, Dextenza has been studied in cataract surgery and resulted in significantly less pain and inflammation than placebo at postoperative days 8 and 14. The bioerodible implant is designed to steadily elute dexamethasone onto the ocular surface for 30 days after surgery and can be administered in the surgical suite or at the slit lamp. Dextenza is also under investigation for the treatment of allergic conjunctivitis.
A small 20-eye retrospective study evaluated a dropless post-vitrectomy regimen using subconjunctival antibiotic and intracanalicular Dextenza. Two eyes required supplemental topical steroids to control inflammation and pain (both of these eyes underwent combined phaco/vitrectomy). At 1 month, there was no significant IOP elevation or macular edema on OCT, and all seven patients who received Dextenza for a second-eye surgery said they preferred the implant over anti-inflammatory drops.
Looking ahead
Both of these sustained-release ophthalmic steroids offer surgeons greater control over postoperative inflammation. As we gain familiarity with their use in the vitreoretinal context, it may become clear that factors such as the type of procedure, patient comorbidities or degree of inflammation will determine use of the intraocular or intracanalicular route.
In ophthalmology, particularly following vitreoretinal surgery, we face numerous practical and physiological barriers to providing continuous control of inflammation. Innovations in sustained-release ophthalmic drugs offer increasingly sophisticated tools for patient comfort and healing.
- References:
- Donnenfeld E, et al. Ophthalmology. 2018;doi:10.1016/j.ophtha.2017.12.029.
- Kiernan DF. BMJ Open Ophthalmol. 2020;doi:10.1136/bmjophth-2020-000491.
- Ocular Therapeutix to present new data at the American Society of Cataract and Refractive Surgery (ASCRS) 2020 virtual annual meeting. https://www.businesswire.com/news/home/20200511005251/en/Ocular-Therapeutix%E2%84%A2-Present-New-Data-American-Society. Published May 11, 2020.
- Suñer IJ. Safety and efficacy of Dextenza implant (intracanalicular dexamethasone 0.4 mg) for postoperative control of inflammation after vitrectomy. Presented at: American Society of Retina Specialists meeting; July 24-26, 2020 (virtual meeting).
- Tyson SL, et al. J Cataract Refract Surg. 2019;doi:10.1016/j.jcrs.2018.09.023.
- For more information:
- Daniel F. Kiernan, MD, FAAO, FACS, can be reached at The Eye Associates, 2111 Bee Ridge Rd, Sarasota, FL 34239; email: danielkiernan714@yahoo.com.
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