NEWS & OPINION EWAP MARCH 2023 47 ASCRS Consensus Statement on VUITY Leads: Douglas Rhee, MD, Cathleen McCabe, MD, Leon Herndon, MD, Rajesh Rao, MD Purpose: On August 16, 2022, the Prescribing Information for VUITY (pilocarpine hydrochloride ophthalmic solution) 1.25% was updated following a voluntary submission by Allergan, an AbbVie company, to the U.S. Food and Drug Administration (FDA). New information has now been included in the Warnings and Precautions, Postmarketing Experience, and Patient Counseling Information sections. This ASCRS Task Force was convened to develop an understanding of the data and a preliminary consensus on appropriate counseling of patients regarding risks associated with the use of VUITY. Overview of the additions to the Prescribing Information for VUITY provided by Allergan: 5. Warnings and Precautions has been updated to include warnings regarding: 5.1 Blurred vision from accommodative spasm and dim vision due to miosis. 5.2 Risk of retinal detachment or retinal tears, with an increased risk in patients with a history of retinal pathology. 6.2. Postmarketing Experience (Under 6. Adverse Reactions) Reported adverse reactions in patients using VUITY postapproval include vitreous detachment, vitreomacular traction, retinal tear, retinal detachment. 17. Patient Counseling Information Information regarding counseling patients on caution with night driving due to dimming of vision and operating machinery due to blurred vision was added. Patients are advised to seek immediate attention for signs and symptoms of a retinal detachment (i.e., flashes, floaters, or vision loss). Summary of FDA registration study findings: Pooled data of two multicenter, prospective, randomized, vehicle controlled, double-masked studies (n=375) reported no cases of retinal tear or detachment in the study period of 30 days with daily bilateral QAM instillation of VUITY. The study included patients with best distance correction sphere of –4.00 D to +1.00 D (inclusive) and cylinder ≤±2.00 D and excluded patients with a history of retinal pathology. The primary endpoint showed that significantly more VUITY participants gained ≥3 lines in mesopic DCNVA, without losing more than 1 line (5 letters) of CDVA at day 30, hour 3 vs. vehicle. Adverse events reported by at least 5% of patients receiving VUITY included headache (15%), conjunctival hyperemia (5%), and blurred vision (5%). 1 Review of literature regarding Postmarketing Experience with VUITY: 1. A case series described two cases of unilateral retinal detachment occurring within 10 days of initiation of pilocarpine 1.25% for the treatment of presbyopia. The patients were pseudophakic men with pre-existing retinal detachment risk factors including high myopia, lattice degeneration, and prior retinal detachment. Both affected eyes were treated with pars plana vitrectomy, gas tamponade, and endo laser and had an uncomplicated postoperative course. 2 2. Three eyes of two patients in their 40s were reported to have retinal tears and detachment soon after instillation of pilocarpine 1.25% for presbyopia. One patient reported noting new onset of flashes and floaters 3 days after use of This article originally appeared in the December 2022 issue of EyeWorld. It has been slightly modified and appears here with permission from the ASCRS Ophthalmic Services Corp.
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