EyeWorld Weekly, September 30, 2022

EyeWorld Weekly, September 30, 2022

EyeWorld Weekly

September 30, 2022 • Volume 28, Number 38

FDA approves new ocular surface anesthesia gel

Harrow Health announced FDA approval of IHEEZO (chloroprocaine hydrochloride ophthalmic gel) for ocular surface anesthesia. According to the company’s press release, this is the first approval in the U.S. for chloroprocaine hydrochloride and “the first branded ocular anesthetic approved for the U.S. ophthalmic market in nearly 14 years.” The company described the gel as sterile and preservative free for use on a single patient. Clinical trials demonstrating safety and efficacy that led to IHEEZO’s approval showed that sufficient anesthesia was achieved 1–1.5 minutes after application, lasting for an average of 22 minutes. The company reported that no patient dosed with IHEEZO needed supplemental anesthesia to complete the surgical procedure.

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New drop approved to reduce IOP

Santen and UBE shared that the FDA approved OMLONTI (omidenepag isopropyl ophthalmic solution) for reduction of IOP in patients with primary open-angle glaucoma or ocular hypertension. According to the company’s press release, this drop is a “relatively selective prostaglandin EP2 receptor agonist” that increases drainage of aqueous humor through trabecular and uveoscleral pathways. It, the company reported, is the only drop to have this mechanism of action. Three clinical trials with OMLONTI showed a 5–7 mm Hg reduction in IOP from baseline, which was 24–26 mm Hg (the company noted that IOP reductions for timolol and latanoprost arms in these studies were 5–7 mm Hg, and 6–8 mm Hg, respectively).

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Newly available IOL incorporates technology that minimizes visual disturbances

Johnson & Johnson Vision announced the launch of a presbyopia-correcting IOL with a new technology that addresses contrast sensitivity and low-light performance. According to the company’s press release, the new TECNIS Symfony OptiBlue IOL is an EDOF IOL with InteliLight technology. The company described InteliLight technology as incorporating a violet-light filter to mitigate visual disturbances, echelette design for reduced light scattering, and achromatic technology for better contrast sensitivity. 

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Interim data from Phase 1 trial for intravitreal implant to treat AMD

Ocular Therapeutix announced interim, 7-month data from its Phase 1 trial evaluating OTX-TKI, an axitinib intravitreal hydrogel implant being investigated for treatment of wet AMD and other retinal diseases. According to the company’s press release, the trial is evaluating a 600 µg single dose of OTX-TKI and 2 mg aflibercept administered 4 weeks after OTX-TKI compared to 2 mg of aflibercept administered every 8 weeks. Patients enrolled in the study had previously been treated with anti-VEGF therapy. The trial, which enrolled 21 patients at 6 clinical sites, is evaluating safety, durability, and tolerability, measuring visual acuity and anatomical changes on OCT. The interim data showed that OTX-TKI was well tolerated with a favorable safety profile; no serious drug-related ocular or systemic adverse effects were seen. Subjects treated with OTX-TKI showed stable, sustained BCVA and central subfield thickness at 7 months, comparable with aflibercept dosed every 8 weeks. The data also showed that 80% of subjects who received OTX-TKI were rescue-free for up to 6 months; 73% in this study arm were rescue-free up to 7 months. 

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Multiparty financing solution brought to ophthalmic practices

CoFi, a multiparty payment platform for elective medical procedures that allows patients to separately pay multiple providers at once, announced an integration with Alphaeon Credit to bring multiparty financing to ophthalmology practices. Using CoFi, practices can now offer patients the ability to finance the fees of every party involved in a premium procedure, such as LASIK, SMILE, and premium IOL cataract surgery, with funds distributed directly to each party compliantly. The company’s press release described the significant financing challenges for services involving multiple parties and the convenient and compliant solution this partnership provides.

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Complimentary access to video journal

The latest issue of the 2022 Video Journal of Cataract, Refractive, & Glaucoma Surgery,founded and edited by Robert Osher, MD, is online now. 

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ASCRS news and events

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Research highlights

  • Researchers for a study published in the journal JAMA Ophthalmology identified 27 studies in peer-review, which included 2,605 patients, and performed a Bayesian network meta-analysis to help determine the most effective IOLs for correcting presbyopia at the time of cataract surgery. The main outcomes were binocular visual acuities by distance and optical quality. According to the paper, all presbyopia-correcting IOLs (older diffractive bifocals and newer trifocals) provided better uncorrected near visual acuity than monofocal IOLs. EDOF IOLs provided better visual acuity than monofocals in the area of uncorrected intermediate vision. The results showed no difference between EDOF and trifocal IOLs in pairwise comparisons. All presbyopia-correcting IOLs, according to the study, were comparable with monofocals for distance vision. The authors wrote that there were no statistical differences between multifocals and monofocal IOLs in contrast sensitivity, glare, or halo. They concluded that for patients considering a presbyopia-correcting IOL at the time of cataract surgery, “bilateral implantation of a trifocal IOL might be an optimal option for patients without compromising distance visual acuity.”
  • A prospective real-world study evaluated the effect of switching from preserved timolol fixed-combinations (PG-timolol FCs) to preservative-free latanoprost timolol fixed combination (PF-LT). The study included 42 patients, with data available from 36 patients, for analysis. IOP, according to the authors, was significantly reduced at the 30- and 90-day timepoints compared to baseline. There was also a significant improvement in OSD symptoms, signs, and visual analog scale scores at these timepoints compared to baseline. The authors concluded that the switch from preserved PG-timolol FC to PF-LT improved tolerability and optimized IOP control by improving adherence. The research is published in the journal Clinical Ophthalmology.

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Product news

  • CryoTreq (BVI), a handheld, single-use, all-in-one device for cryosurgery, was introduced into the U.S. market.

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This issue of EyeWorld Weekly was edited by Stacy Jablonski and Liz Hillman.

EyeWorld Weekly (ISSN 1089-0319), a digital publication of the American Society of Cataract and Refractive Surgery (ASCRS), is published every Friday, distributed by email, and posted live on Friday.

Medical Editors: Sumit “Sam” Garg, MD, Chief Medical Editor; Rosa Braga-Mele, MD, Cataract Editor; Clara Chan, MD, Cornea Editor; Nathan Radcliffe, MD, Glaucoma Editor; and Vance Thompson, MD, Refractive Editor

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