EyeWorld Weekly, April 29, 2022

EyeWorld Weekly, April 29, 2022

EyeWorld Weekly

April 29, 2022 • Volume 28, Number 17

Topline results from Phase 3 trials of presbyopia-mitigating drop

Orasis Pharmaceuticals announced topline results from its two Phase 3 clinical trials, NEAR-1 and NEAR-2, for its CSF-1 (pilocarpine hydrochloride) presbyopia-mitigating drop. According to the company’s press release, these trials will be used as the basis for regulatory submission to the FDA in the second half of 2022. In both trials, which enrolled a total of 613 participants, CSF-1 met its primary and key secondary endpoints on day 8, achieving a statistically significant, 3-line or more gain in distance-corrected near visual activity and no loss of 1 line or more in distance visual acuity. Pooled data from the studies showed that 40% and 50% of participants demonstrated these gains 1-hour post-dose 1 and 1-hour post-dose 2, respectively. There was a 3-line improvement at all timepoints on days 1 and 15. On day 15, participants had a 3-line or more improvement in DCNVA as early as 20 minutes and up to 8 hours post-dose 1. The treatment was determined tolerable and safe, with the most common adverse, treatment-related events being headache (6.8%) and instillation pain (5.8%); 2.6% of participants reported moderate treatment-related adverse events.

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Study: Long-term visual outcomes of at-home telemonitoring

Notal Vision announced the results of its Analysis of Long-term visual Outcomes of ForeseeHome Remote Telemonitoring (ALOFT) study, published in Ophthalmology Retina. The study showed long-term, positive visual outcomes for participants in the program, according to the company. The study followed 2,123 patients with dry AMD from five retina centers for a 10-year period. Visual acuity at conversion to wet AMD was 20/39, which the company reported exceeded the mean visual acuity of 20/80 after 2 years with the current standard of care (based on American Academy of Ophthalmology [AAO] IRIS Registry data). Average testing per week by participants was 5.2, which the company noted shows strong compliance.

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AAO IRIS Registry Report

Verana Health announced findings from the AAO IRIS Registry Industry Report for 2021, providing, according to its press release, “8 years of detailed ophthalmic insights generated through analysis of the data contained in the IRIS Registry, powered by Verana Health’s VeraQ population health data engine.” Notably, the report showed a more than 80% increase in glaucoma surgeries from 2013–21. The data showed some shifts in types of glaucoma procedures performed. It found trabeculectomies peaked in 2015 at 14,600 procedures annually and declined to 9,300 per year in 2021. Verana Health’s press release noted an increase in trabecular meshwork bypass stents during this timeframe.

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Innovations in capsulotomy technology

Centricity Vision, which makes the Zepto automated capsulotomy device, announced two innovations: the Zeptolink platform and Zepto 5.5 mm capsulotomy technology. According to the company’s press release, Zeptolink is designed to integrate with any phaco system to save time and space in the OR. Centricity is also developing a new handpiece to create a 5.5-mm anterior capsulotomy (a 5.2 mm device is already available).

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Complimentary access to video journal

The first issue of the 2022 Video Journal of Cataract, Refractive, & Glaucoma Surgery, founded and edited by Robert Osher, MD, is online now. This edition of the educational, online resource focuses on “Great Lectures!”

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ASCRS news and events

  • 2022 ASCRS Annual Meeting: Catch up on coverage from the Annual Meeting, which wrapped up on Tuesday, with the EyeWorld Daily and EyeWorld Onsite.
  • ASCRS Grand Rounds: ASCRS Grand Rounds, presented by NYU Langone Department of Ophthalmology, is available on demand.
  • Ophthalmology Quicksand Chronicles: Watch the latest episode of this popular ASCRS podcast hosted by Nicole Fram, MD, and Elizabeth Yeu, MD, with guest Amar Agarwal, MD.

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Research highlights

  • Research published in Clinical Ophthalmology objectively looked at whether angle kappa influenced clinical outcomes or patient-reported satisfaction and visual quality in the setting of trifocal IOLs. The study included 56 eyes of 28 patients who bilaterally chose the PanOptix IOL (Alcon). According to the study, 26 eyes had an AK magnitude of less than 0.3 mm, 14 had an AK from 0.3 mm–0.4 mm, and 16 had an AK of more than or equal to 0.4 mm. Visual disturbances like glare, halo, starbursts, and spectacle dependence were not correlated with magnitude of angle kappa. Magnitude of postop AK was significantly lower than preop, the authors found. They concluded that the “magnitude of preoperative angle kappa had no apparent effect on the refractive, visual acuity, or subjective (visual disturbances, quality of vision, satisfaction) clinical outcomes with this trifocal IOL.”
  • The relationship between lid wiper epitheliopathy (LWE), tear abnormalities, and blinks in dry eye was investigated in a paper published in Cornea. The authors included 76 eyes of 76 female patients with dry eye, measuring tear meniscus radius, spread grade of the tear film lipid layer (on a scale of 1–5 with 1 being the best), fluorescein breakup time, fluorescein breakup pattern, corneal and bulbar conjunctival epithelial damage, upper eyelid LWE grade, and Schirmer score. A high-speed blink analyzer was also used to assess blink rate, palpebral aperture high, and upper eyelid opening/closing amplitude, duration, and velocity. The investigators found that tear volume, tear film stability, and blink were risk factors in determining severity of LWE.

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Product news

  • CorneaGen launched its new, FDA-approved EndoSerter, which is single-use and preloaded with donor tissue for DSEK surgery.
  • Haag-Streit launched its Eyestar 900 Anterior Chamber Suite, complementing its Cataract Suite.
  • Johnson & Johnson Vision launched its next-generation TearScience Activator Clear, which the company stated builds on the legacy of the TearScience LipiFlow Thermal Pulsation System. The new system, according to the company’s press release, provides greater treatment precision.
  • Thea Pharma introduced its line of iVIZIA over-the-counter eyecare products in the U.S.
  • Ziemer announced FDA approval of its Femto Z8 Neo, a multipurpose laser platform for refractive, therapeutic, and cataract surgery.

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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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