TECNIS Synergy and TECNIS Synergy Toric II Available in the US and Canada

• Johnson & Johnson Vision has announced that the TECNIS Synergy and TECNIS Synergy Toric II IOLs are now available in the United States and Canada. The company says these presbyopia-correcting IOLs (PCIOLs) combine the best of extended depth of focus and multifocal technologies to deliver the widest range of continuous vision and the best near vision among leading PCIOLs, without the visual gaps seen with some existing multifocal technologies. J&J Vision says the Synergy IOL, built on the legacy TECNIS platform, delivers excellent performance, image contrast, and patient outcomes. The TECNIS Synergy PCIOL was first launched in Europe and the Asia Pacific region in 2019.

In June, J&J Vision provided education to patients and caregivers about the symptoms of cataracts, and the treatment options, in honor of Cataract Awareness Month. The company shared cataract patient stories and information from ophthalmologists through various media, digital, and social media channels.

The TECNIS Synergy and Synergy Toric II IOLs are discussed in the “On Point” product feature on page 48 of this issue.

Eyenovia Provides Details on MicroLine Study

• Eyenovia has provided additional details from its phase 3 VISION-1 clinical trial, which evaluated the company’s proprietary pilocarpine solution, MicroLine, administered via the Optejet dispenser, for the treatment of presbyopia. VISION-1 evaluated the safety and efficacy of MicroLine presbyopia microdose formulations vs placebo, all administered via Eyenovia’s proprietary Optejet delivery Micro-Array Print technology.

In the group receiving the 2% MicroLine dose, a higher proportion of subjects met the primary endpoint of 3-line or greater improvement in near vision compared to placebo, a higher proportion of subjects achieved 2-line or greater improvement in near vision compared to placebo, and 71% of patients reported a meaningful improvement in near vision, according to an exit survey conducted by the study investigators. All ocular adverse events were trace to mild in severity and transient in nature. The company noted fewer than 3% of study participants reported headache and brow ache, which it says compares very favorably to eyedrop formulations of pilocarpine, which has been observed in prior studies to cause brow ache or headache in 20% to 25% of study participants.

To support the submission of a New Drug Application (NDA), the company is on track to initiate a second phase 3 trial, VISION-2, later this year. VISION-2 will be a double-masked, placebo-controlled, crossover superiority trial designed to enroll 120 patients randomized between 2% pilocarpine and placebo cohorts. Topline data are anticipated in mid-2022.

Bausch + Lomb Expands Parameters for ULTRA Multifocal for Astigmatism Contact Lenses

• Bausch + Lomb has announced expanded parameters in the US for its ULTRA Multifocal for Astigmatism contact lenses. The expansion includes the addition of -2.25-D and -2.75-D cylinder power parameters, and B+L says it will provide a broader offering for presbyopic patients with astigmatism. As part of the company’s standard offering, the lens will extend the power range available to eyecare professionals and their patients who have both astigmatism and presbyopia.

Scott Schachter, OD, to Join Allergan’s Presbyopia Team

• Allergan has announced that Scott Schachter, OD, will serve as the company’s scientific director of presbyopia and ocular surface disease. Dr. Schachter is an adjunct clinical professor at Southern California College of Optometry and a global ambassador for the Tear Film & Ocular Surface Society, and he runs a private practice in Pismo Beach, CA.

Lentechs Enrolls First Patients in Studies of Investigational Contact Lenses

• Lentechs is a clinical-stage ophthalmic medical device company developing a new generation of soft, suspended contact lens, which the company says are designed to transform the treatment paradigm for presbyopia. The first patients have been enrolled in the company’s two clinical trials, LEN101 and LEN102, and fit with its investigational contact lens, APIOC.

According to Lentechs, APIOC’s design leverages a unique, anatomically inspired feature that allows for free eye movement behind a rotationally stable lens. This allows wearers to adjust their gaze by moving their eyes up and down behind the lens, for exceptional vision correction at all distances.

Ocuphire Appoints Jay S. Pepose, MD, PhD, to Its Board of Directors

• Ocuphire Pharma, a clinical-stage ophthalmic biopharmaceutical company focused on developing and commercializing therapies for the treatment of several eye disorders, including Nyxol for presbyopia, has appointed Jay S. Pepose, MD, PhD, to its board of directors. Concurrent with Dr. Pepose’s appointment at Ocuphire’s annual shareholder meeting on June 7, Alan Meyer, MBA, retired from his role on the board, having served since April 2018. Dr. Pepose has served as an investigator on more than 30 separate clinical trials, evaluating new therapeutics and technology across a broad range of ophthalmic indications, including adenoviral and bacterial conjunctivitis, meibomian gland dysfunction, dry eye disease, open-angle glaucoma, ocular hypertension, anterior uveitis, and reversal of presbyopia.

LENZ Therapeutics Emerges With $47 Million in Financing

• LENZ Therapeutics (formerly Presbyopia Therapies) is a late-stage clinical company whose lead program is an aceclidine-based eyedrop designed to restore the loss of near vision associated with presbyopia. The company has completed $47 million Series A of financing from Versant Ventures and RA Capital Management. Proceeds from the financing will be utilized to progress the company’s lead asset toward an NDA submission for the treatment of presbyopia. CEO Eef Schimmelpennink said he and the team look forward to continuing the work of Presbyopia Therapies’ founders Gerald Horn, MD, Lee Nordan, MD, and Jim McCollum.

Digitized Minioptofluidic Element and Its Application to Ophthalmic Lenses for Presbyopia Correction

• Researchers in California have designed a digitized minioptofluidic element, with a multichamber configuration, for fast switching between refractive and diffractive states of preset optical powers, to examine its potential application for presbyopia correction by ophthalmic lenses. The group created a prototype as proof-of-concept, which they say combines simplicity of focus-adjustable optofluidic elements and fast switching performance of material-based electronic elements. The researchers say the analysis supported switching operations under a force level exerted on the ophthalmic lenses by the corresponding ocular elements, which would be ciliary muscle in the case of a switchable intraocular lens and the lower eyelid at eye downgaze in the case of a switchable contact lens. The researchers concluded that their study¹ did demonstrate the potential of the surface-based switchable technology for presbyopia correction by ophthalmic lenses.

Reference

1. Portney V, Christ FR, Christ MD. Digitized mini optofluidic element and its application to ophthalmic lenses for presbyopia correction. Opt Express. 2021;29(11):16105-16117.

Spectacle Independence and Quality of Vision After Bilateral Implantation of a Trifocal Intraocular Lens

• The authors of this study evaluated patient-reported spectacle independence and quality of vision for patients who were bilaterally implanted with a trifocal intraocular lens (IOL). Included were patients who presented for cataract surgery who had an interest in reducing their dependence on glasses at multiple distances. The patients were bilaterally implanted with a trifocal IOL, and followed for 3 months. At the 3-month visit they were given a spectacle independence questionnaire and a quality of vision questionnaire. In the study, 26 of 29 subjects (90%) reported being completely or mostly satisfied with their vision overall, without the use of glasses or contact lenses. All but one reported no need for glasses for distance and intermediate work, and 25 of 29 reported no need for glasses for near work. Almost all subjects reported never wearing glasses or wearing them only a little, and being able to function without glasses at any distance all or most of the time. The authors concluded the trifocal IOL is a viable alternative for patients looking to reduce their overall dependence on spectacles after cataract surgery.

Reference

1. Shatz AC, Potvin R. Spectacle independence and quality of vision after bilateral implantation of a trifocal intraocular lens. Clin Ophthalmol. 2021;15:2545-2551. Published 2021 Jun 17. doi:10.2147/OPTH.S318203.

A New Trifocal Corneal Inlay for Presbyopia

• A group from Valencia, Spain, says it has demonstrated the feasibility of the first trifocal corneal inlay for presbyopia treatment.¹ It describes what they call a pure phase diffractive device that is fully transparent to improve light efficiency. The group assessed the image quality and optical properties of the device, the Phase Diffractive Corneal Inlay (PDCI), in comparison with those of a commercially available refractive CI. Software was used to simulate the effects of both inlays. The analysis utilized the modulation transfer function (MTF) and the area under the MTF as merit functions, and a visual simulator was employed to obtain experimental images provided by the PDCI of objects at different vergences. The authors concluded that the implantation of PDCI seems to be an interesting alternative to be explored for phakic presbyopic patients who desire spectacle independence and would be fully compatible with (previous or in combination) laser refractive procedures in myopic and hyperopic patients, as well as with cataract surgery afterward.

Reference

1. Furlan WD, Montagud-Martínez D, Ferrando V, et al. A new trifocal corneal inlay for presbyopia. Sci Rep. 2021;11(1):6620. doi:10.1038/s41598-021-86005-8

Visus Therapeutics Announces Executive Leadership Appointments

• Visus Therapeutics has announced 6 executive leadership appointments, to support its presbyopia development program and pipeline expansion. The appointments include Tim Grinstead as chief operating officer, James Burke as vice president of research, Patrick Hughes, PhD, as vice president of pharmaceutical development, Lisa Simpson as vice president of clinical operations and compliance, Guru Sharma, OD, PhD, as director of ophthalmology and clinical development, and Alex Oh as vice president of intellectual property. ■