• Johnson & Johnson will preview its new presbyopia-correcting IOL, Tecnis Odyssey, at the 2024 ASCRS annual meeting. The technology is designed to provide full visual range, reduced night vision symptoms and best-in-category contrast and low-light performance. Among 28 company-sponsored and investigator-led studies showcased at the meeting, five will focus on the real-world outcomes delivered by Tecnis Odyssey, led by surgeons with early access to the technology. Tecnis Odyssey is expected to be fully commercially available in the United States during the second half of 2024. In a series of professional educational offerings and peer-led discussions, found here, key opinion leaders who have experience implanting Tecnis Odyssey will share their experiences, insights and data gathered ahead of the full market release.

• Viatris Inc. announced the US commercial launch of RYZUMVI (phentolamine ophthalmic solution) 0.75% for the treatment of pharmacologically-induced mydriasis produced by adrenergic agonists (eg, phenylephrine) or parasympatholytic (eg, tropicamide) agents in the United States. According to the company, RYZUMVI is the only US commercially available FDA-approved eyedrop to reverse dilation. The FDA approved RYZUMVI in September 2023.  

• Haag-Streit launched the Eyesi Indirect Ophthalmoscope ROP Simulator (Eyesi Indirect ROP) for the training of retinal examinations on premature babies and classification of retinopathy of prematurity (ROP). The Eyesi Indirect ROP is a mixed-reality simulator that offers a highly immersive training environment for proper device handling, with an embedded, didactically structured simulator curriculum to teach the diagnostic skills required for correct ROP classification. The simulator resembles every relevant aspect of the real examination scenario. It consists of a head-mounted stereo display representing an ophthalmoscope, a patient model head with pliable eyes, and mimics of lenses and a scleral depressor.

• Nanoscope Therapeutics announced positive top-line results after the completion of the 2-year Phase 2b RESTORE randomized, controlled clinical trial of its lead program, MCO-010, a mutation-agnostic gene therapy for patients with permanent and severe vision loss from advanced retinitis pigmentosa. The trial met its primary endpoint, demonstrating a statistically significant improvement of BCVA at week 52 in both the high-dose (0.337 LogMAR; p=0.021) and low-dose (0.382 LogMAR; p=0.029) treatment groups compared to the sham control group (0.050 LogMAR). Additionally, improvements in visual function persisted or increased following week 52 in the study, demonstrating the durable effect of a single intravitreal injection of MCO-010. BCVA improvement at week 76, a key secondary endpoint, was statistically significant in the high-dose treatment group compared to the control group (0.539 LogMAR; p=0.001). For more, see the study results here.

• iOR Partners announced a strategic alignment with the Joint Commission on national accreditation standards for office-based surgery (OBS) centers. The collaboration offers iOR OBS suites the same quality framework trusted by nearly every one of the country’s top ambulatory operating suites, the companys says. iOR partners says surgeons will gain benefits from Joint Commission accreditation such as: A tailored survey approach, specific to ophthalmic OBS; a dedicated Joint Commission team, providing consistency to the survey process; a dedicated Joint Commission director of the application/re-application process, providing timely survey and accreditation results; and dedicated tools and services, including an extranet site for application fees, survey preparation tools and resources, and ongoing accreditation maintenance. 

• CSI Dry Eye Software released Version 5.0 of its latest software update, which the company says provides features and enhancements for more efficiency, accuracy and simplicity in preoperative assessment and dry eye management. Some of the features include: Expanded language support for French and Spanish; enhanced visuals with charts that have been integrated into assessments; an integrated medical intake form; a medication notification for drug side effects or issues related to eye disease; a referral center to help clinics manage incoming and outgoing referrals as well as add attachments; a new inbox System; and simplified Aassessments with several preoperative and dry eye assessment screenings. 

• Aldeyra Therapeutics announced the clinical development plan intended to enable resubmission of a new drug application (NDA) of topical ocular 0.25% reproxalap, an investigational RASP modulator for the treatment of dry eye disease, to the FDA. Following discussions with the FDA, Aldeyra intends to initiate a dry eye chamber clinical trial in the first half of 2024. Contingent on positive results from the planned clinical trial, NDA resubmission is expected in the second half of 2024. Based on FDA guidance, the planned review period for the potential NDA resubmission is expected to be 6 months.

• Prevent Blindness declared April as Women’s Eye Health and Safety Month. The organization is offering free resources, including fact sheets, shareable social media graphics and educational videos and web pages, on a range of eye health issues that predominantly affect women. New this year, Prevent Blindness is collaborating with the Delta Gamma Foundation to share co-branded resources and information with their members on topics specifically related to women’s eye health. Delta Gamma Alumna Dr. Lauren C. Ditta, MD, will be participating in a new episode of the Prevent Blindness Focus on Eye Health Expert Series, to address children’s vision and parent advocacy. Additionally, another segment of the Prevent Blindness Focus on Eye Health Expert Series will focus on a variety of women’s eye health issues including vision loss and mental health, access to eye care and general tips for women to keep eyes healthy. For more information on these resources, click here. 

• SpyGlass Pharma announced 1-year follow up data from a first-in-human study of 23 patients with glaucoma or ocular hypertension implanted with SpyGlass’ IOL-based Drug Delivery Platform with bimatoprost at the time of cataract surgery. One year after implantation, the enduring IOP reduction remained consistent across all three dose strengths, achieving a mean pressure reduction of 44.6% at month 12 compared to preoperative washed-out baseline levels. All patients sustained more than a 20% IOP reduction from baseline and IOP of ≤18 mm Hg through month 12. Additionally, 100% of patients remain off topical IOP-lowering drops. The SpyGlass platform was well tolerated, and there were no adverse events related to the product.

• Qlaris Bio announced the initiation and dosing of two separate US Phase 2 masked, randomized clinical trials investigating QLS-111 in patients with ocular hypertension and glaucoma. The Osprey study will assess the safety, tolerability and optimal dose of QLS-111 compared with vehicle alone in adult patients who have primary open-angle glaucoma and/or ocular hypertension (OHT). The efficacy of QLS-111 in lowering IOP will be assessed as a secondary endpoint of the trial. The Apteryx study will evaluate the safety and tolerability and measure the additive IOP-lowering efficacy of QLS-111 in combination with latanoprost vs latanoprost alone. Patients aged 12 years or older and who have open-angle glaucoma and/or OHT currently on latanoprost will be enrolled in the trial.

• REGENXBIO Inc. published two-year data from its Phase 1/2a trial evaluating the safety and tolerability of a single dose of subretinal ABBV-RGX-314 for the treatment of wet AMD. The findings demonstrated that a single administration of ABBV-RGX-314 was generally well tolerated. Stable or improved visual acuity and retinal thickness was observed with few or no supplemental anti-VEGF injections in most patients at 2 years. Patients who received therapeutic doses demonstrated sustained levels of ABBV-RGX-314 protein and stable or improved vision and retinal anatomy with few, to no, supplemental anti-VEGF injections in most participants up to 2 years. In addition, the company reported positive interim data from a long-term follow-up study of ABBV-RGX-314 supporting that treatment continues to be well-tolerated and demonstrates long-term, durable treatment effect up to 4 years.

• Researchers at Boston Children’s Hospital discovered that two types of strabismus — esotropia and exotropia — may have shared genetic risk factors. Duplications on the second, fourth and 10th chromosomes that were present in patients with esotropia were also found in patients with exotropia. Published in JAMA Ophthalmology, a cross-sectional study including 234 individuals showed that genetic duplications associated with esotropia on chromosomes 2, 4, and 10 were found to be present in 1.7%, 3.0% and 6.0% of individuals with exotropia, respectively. These are similar proportions as reported in individuals with esotropia and higher than controls; individuals with a duplication had a larger magnitude of exotropia, a higher frequency of constant (vs intermittent) deviation and higher rates of strabismus surgery. The results suggest that genetic risk factors for esotropia also were risk factors for exotropia, supporting a common genetic risk for both forms of strabismus. For more, see the study results here.

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.