• Eyenovia Inc. announced the FDA approved Mydcombi (tropicamide and phenylephrine hydrochloride ophthalmic spray) 1%/2.5% for inducing mydriasis for diagnostic procedures and in conditions where short-term pupil dilation is desired. This represents the first approved fixed-dose combination of tropicamide and phenylephrine in the United States and also the first product using Eyenovia’s proprietary Optejet device to be approved by any regulatory authority.

• C. Light Technologies announced its device, the Retitrack, the first retinal eye-movement monitor for non-invasive, objective clinical assessments, has been cleared for marketing through premarket notification 510(k) from the FDA. The Retitrack is a monocular, tabletop eye movement monitor that is intended for recording, viewing, measuring and analyzing temporal characteristics of fixation and saccadic responses when viewing a visual stimulus. The device operates by recording 10-second, high-resolution retinal videos at the photoreceptor level, allowing for quantification of eye motion down to 0.1°. Its accompanying software extracts and analyzes both fixation (microsaccades and drift) and saccadic eye movements in real time and generates a comprehensive summary report for clinical interpretation.

• Glaukos Corp. received the “Day 74” notification from the FDA acknowledging the previously submitted new drug application (NDA) for iDose TR (travoprost intraocular implant) is sufficiently complete to permit a substantive review. iDose is intended to address patient non-compliance and chronic side effects associated with topical glaucoma medications. The Prescription Drug User Fee Act goal date for the completion of the FDA’s review of the iDose TR NDA is set for Dec. 22, 2023. This date reflects a standard 10-month review period and is consistent with management’s expectations for the 505(b)(2) filing.

• The FDA accepted Genentech’s supplemental Biologics License Application (sBLA) for Vabysmo (faricimab-svoa) for the treatment of macular edema following retinal vein occlusion. The sBLA is based on results from the Phase 3 BALATON and COMINO studies that demonstrated treatment with Vabysmo provided early and sustained improvement in vision, meeting the primary endpoint of non-inferior visual acuity gains at 24 weeks compared to aflibercept. Vabysmo’s safety profile was consistent with previous trials. The studies are ongoing, and data from weeks 24 to 72 will assess the potential of Vabysmo to extend dosing intervals up to every 4 months.

• Cassini launched the Cassini Connect digital cataract surgery suite. Compatible with most leading microscope brands, Cassini Connect provides an integrated cataract surgery workflow and data solution — from preop diagnostics, digital ocular registration and marking to cloud-based surgery planning and intra-op visualization and guidance. The suite allows cataract surgeons to save 7 minutes per patient spent on the conventional method of using preoperative corneal ink marking by using the Cassini digital ocular registration, the company says. The integrated platform allows the pre-op diagnostic data to feed into a cloud-based planner, which is accessible from any laptop or smart device.

• Salvat Laboratories reported the results of Phase 3 clinical trials of its ophthalmic corticosteroid at the ARVO annual meeting. A poster was presented outlining the SVT-15473 clobetasol 0.05% ophthalmic nanoemulsion Phase 3 clinical trial results for the treatment of inflammation and pain post ocular surgery. The presentation included the pooled data of two successful Phase 3 clinical trials of clobetasol, which were conducted between 2020 and 2021, testing more than 400 patients in more than 40 specialized centers in the United States. The trials demonstrated the efficacy and safety of this approach, with clobetasol proving effective in reducing inflammation and pain in post-ocular surgery patients.

• Sight Sciences announced the results from a 12-month retrospective sub-analysis of IOP-lowering medication use following the three most commonly performed, FDA-approved minimally invasive glaucoma surgery procedures in patients with mild stage glaucoma. Analysis of medical records of 16,789 mild glaucoma patients in four different cohorts in the AAO IRIS Registry showed that patients in the OMNI technology cohort experienced the greatest average medication reduction with a mean reduction from baseline of 1.01 glaucoma medications at 12 months postoperatively.

• Trefoil Therapeutics announced TTHX1114, an engineered form of Fibroblast Growth Factor, was found to improve the rate of visual recovery and corneal deturgescence after Descemet stripping only (DSO) in a dose-responsive manner in the Phase 2 STORM study. The Phase 2 STORM study evaluated the safety and efficacy of TTHX1114 delivered as an intracameral injection as an adjunct to DSO. Data showed TTHX1114 improved BCVA and central corneal thickness after DSO in the 49 subjects/64 eyes. A separate STORM analysis assessed visual morbidity in patients with Fuchs’ endothelial corneal dystrophy prior to surgery using the V-Fuchs Questionnaire (V-FUCHS). Data from the Phase 2 STORM study was utilized to assess the baseline characteristics of subjects and identify quality of vision characteristics that may motivate patients to seek DSO surgery. Despite baseline assessments showing reasonably good vision, even in the presence of disease, results from the V-FUCHS suggest moderate vision interference in daily activities, difficulty in seeing fine details and issues with glare and halos, particularly at night. The abstracts can be found online here.

• Atia Vision presented the first clinical data on its patented OmniVu IOL System at the ASCRS annual meeting. The trial evaluated the safety and effectiveness of the presbyopia-correcting, modular IOL system to provide improved distance, intermediate and near visual acuities in adult subjects 3 months following cataract surgery. The IOL demonstrated the ability to achieve predictable refractive outcomes near plano while also providing functional distance-corrected intermediate visual acuity and distance-corrected near visual acuity with great patient satisfaction and an excellent safety profile. 

• Dry Eye Foundation identified more than 50 eyedrops for sale online that raise safety flags and has offered to help Amazon and Walmart address this growing problem. Twenty-seven out of 39 brands listed on the Foundation’s Product Alerts page at eyedropsafety.org are currently available for sale on Amazon, Walmart or both. In order to be legally sold, eyedrops must be registered with the FDA’s drug database and comply with various Federal safety regulations. The foundation reports that many smaller companies selling eyedrops online are ignoring some, most or all of these rules. According to Sandra Brown, MD, Dry Eye Foundation’s medical advisor, the foundation has found counterfeits of national brands, eyedrops with no lot number, no expiration date and no ingredient list.

Quick Notes is published weekly. Unless otherwise noted, the information presented is based on press releases. Find earlier editions here. To submit a press release to be considered for publication, click here.