Eyeworld

32 | EYEWORLD | DECEMBER 2022 ASCRS NEWS 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 follow- ing 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 histo- ry of retinal pathology. 6.2. Postmarketing Experience (Under 6. Adverse Reactions) Reported adverse reactions in patients using VUITY postapproval include vitreous detach- ment, 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 cylin- der ≤±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 degenera- tion, and prior retinal detachment. Both affected eyes were treated with pars plana vitrectomy, gas tamponade, and endo laser and had an uncom- plicated postoperative course. 2 2. Three eyes of two patients in their 40s were re- ported to have retinal tears and detachment soon after instillation of pilocarpine 1.25% for presby- opia. One patient reported noting new onset of flashes and floaters 3 days after use of the drop and was found on examination 1 month later to have retinal tears and limited detachments in both eyes. A second patient noted a visual field defect 5 weeks after instillation of the drop and had a retinal detachment with subretinal fluid extending into the macula. 3 3. This is a case report of a 65-year-old patient who developed vitreomacular traction following instillation of one dose of pilocarpine 1.25%. 4 Summary of Task Force recommendations: An increased risk of retinal traction, tears, and detachment has been associated with miotics such as pilocarpine. Physicians should inform patients who desire treatment of presbyopia with miotics including pilocarpine of this potential adverse event. The duration of miotic registration studies and the included population parameters should be considered when applying risk/benefit assessments to specific patients. Before prescribing miotics, one should consider performing a dilated fundus ex- amination as part of the individual risk assessment for retinal detachment. One may also consider other specific diagnostic testing, such as optical coherence tomography (OCT macula), based on clinical considerations. Patients should be educated regarding symptoms of retinal tears or detachment, including flashes, floaters, and visual field loss and should be advised to seek medical attention urgent- ly should any of these symptoms occur. References 1. Waring GO, et al. Safety and efficacy of AGN-190584 in individuals with presbyopia: the GEMINI 1 Phase 3 randomized clinical trial. JAMA Ophthalmol. 2022;140:363–371. 2. Eton EA, et al. Rhegmatogenous retinal detachment following initiation of pilocarpine hydrochlo- ride ophthalmic solution 1.25% for treatment of presbyopia. Retin Cases Brief Rep. 2022. Online ahead of print. 3. Al-Khersan H, et al. Retinal detachments associated with topical pilocarpine use for presbyopia. Am J Ophthalmol. 2022;242:52–55. 4. Amarikwa L, et al. Vitreofoveal traction associated with pilocarpine for presbyopia. Ophthalmic Surg La- sers Imaging Retina. 2022;53:410–411. Disclaimer: This Consensus Statement is provided by ASCRS for informational and educational purposes only and is intended to offer practitioners recommended monitoring and treatment options for patients who desire treatment of pres- byopia with miotics including pilocarpine. Practitioners should use their personal and profes- sional judgment in interpreting these recommendations. This document is not intended to provide medical advice, create a standard of care, or be deemed inclusive of all proper methods of care nor exclusive of other meth- ods of care reasonably directed to obtaining the same results. Adherence to these recommen- dations will not ensure successful treatment in every situation. The information in this statement is provided "as is," and ASCRS makes no warranties as to its accuracy or completeness. This Consensus Statement may need to be updated as future studies are conducted. ASCRS plans to further address this topic in a roundtable that will discuss VUITY, as well as the overall market for presbyopia drops and potential market opportunities and risks. VUITY data and experience (including off-label use) and patient education tactics will be reviewed. —Sumit "Sam" Garg, MD EyeWorld Chief Medical Editor

• Blank Page
• Blank Page (1)