Phase 3 clinical trial for water-free dry eye cyclosporine drop

The results from a randomized Phase 3 clinical trial for SHR8028 (CyclASol, Novaliq), a water-free formulation of cyclosporine ophthalmic solution, 0.1%, was published in JAMA Ophthalmology. The study included 206 patients with moderate to severe dry eye disease from 12 hospitals in China, enrolled between March 2021 and July 2022; 103 were assigned to the cyclosporine group and 103 to vehicle. Change in total corneal fluorescein staining (tCFS) was evaluated at day 29. The investigators found that the participants in the cyclosporine group saw an improved tCFS compared to vehicle. There was a –4.8 decrease in tCFS from baseline in the cyclosporine group compared to –3.0 in the vehicle group. The authors reported a decrease in dryness score from baseline in both groups. Treatment-related adverse events occurred in 14.6% of participants in the cyclosporine group and 10.7% of participants in the vehicle group. The authors concluded that the cyclosporine treatment was superior compared to vehicle in improving tCFS scores at day 29, but the dryness scores were not improved at day 29.

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Phase 2b results for drug-eluting contact lens for glaucoma

MediPrint Ophthalmics announced Phase 2b group 1 (low dose) results for its drug-eluting contact lens for glaucoma. According to the company’s press release, LL-BMT1 is a preservative-free weekly biomatoprost-releasing contact lens for open angle glaucoma and ocular hypertension. Eleven patients, who were not previous contact lens wearers, were included in this group. Patients participated in the study for 3 weeks, receiving a new LL-BMT1 contact lens for each eye every 7 days. Their response was compared to a reference arm that involved participants using topical timolol, 0.5%, twice daily for 3 weeks. According to the company, LL-BMT1 achieved a clinically meaningful IOP reduction of 5.5 mm Hg, which was comparable to the reference arm. IOP was reduced 14%, 18%, and 19% from baseline in week 1, 2, and 3, respectively. The press release noted minimal IOP fluctuation during the study duration. There were no serious treatment-emergent adverse events, and the contact lenses were well tolerated. Next, the company is moving onto the Phase 2b group 2 (medium dose) portion of the study.

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Dosing continues for Phase 1/2 trial evaluating gene therapy for X-linked retinoschisis

Atsena Therapeutics has begun dosing patients in its second cohort as part of its Phase 1/2 clinical trial for ATSN-201, a gene therapy being developed as a possible treatment for X-linked retinoschisis (XLRS). The company reported no serious adverse events in its first cohort, which included three patients. The company’s goal, according to its press release, is for the treatment to “achieve therapeutic levels of gene expression in photoreceptors of the central retina while avoiding the surgical risks of foveal detachment.” The company’s trial is an open-label, dose-escalation, and dose-expansion study, evaluating safety and tolerability of the gene therapy in male patients 6 years and older with XLRS caused by mutations in the RS1 gene. Enrollment for this study is ongoing.

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Higher dose, extended wet AMD treatment non-inferior to standard of care

Regeneron announced that a study published in The Lancet has shown that EYLEA HD (aflibercept injection), 8 mg, with extended dosing regimens at 12- or 16-week intervals is non-inferior in visual gains compared to standard of care EYLEA (aflibercept injection), 2 mg, at 8-week dosing intervals for patients with wet AMD and DME at 1 year. These findings, according to the company’s press release, support the potential for EYLEA HD to reduce treatment burden for patients. EYLEA HD is already approved in the U.S., within the European Union, and in Japan.

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Study: AI detects severe retinopathy of prematurity with 100% accuracy

Research from Oregon Health & Science University has found that AI can detect severe retinopathy of prematurity with 100% accuracy. Physician investigators in the university’s news release stated that this technology (based on the i-ROP Deep Learning system) could expand the screening availability in a telemedicine capacity and lead to sight-saving treatment. In this study, the i-ROP Deep Learning system analyzed nearly 12,000 images from more than 4,000 infant retinas. The photos were taken by nurses at neonatal intensive care units. The university stated that the images were reviewed by ophthalmologists initially, who identified that 1.2% had severe forms of ROP and 5.8% had “more-than-mild” ROP. The AI system identified all the severe cases and detected 80% of the “more-than-mild” cases. The research is published in JAMA Ophthalmology.

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Complimentary access to video journal

The latest issue of the 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

• ASCRS Annual Meeting: The ASCRS Annual Meeting is just a few weeks away, April 5–8 in Boston, Massachusetts. There is still time to register online or onsite. Take a look at the 2024 Annual Meeting & Subspecialty Day Real-Time Program for more details.
• EyeWorld Corporate Events: EyeWorld is hosting more than a dozen Corporate Education events during the ASCRS Annual Meeting in Boston. Click here to learn more about these opportunities and to pre-register.

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Research highlights

• The Light Adjustable Lens (LAL, RxSight) in combination with cataract surgery and DMEK for Fuchs was evaluated in a retrospective review of an initial case series from a single private practice, tertiary referral center. According to the paper published in the Journal of Cataract & Refractive Surgery, lenses were adjusted (starting after refraction stabilized) based on postop manifest refraction and locked in 3–6 months postop. Twenty-seven eyes of 17 patients were evaluated; 6 eyes had a near or intermediate target and 21 eyes had a distance target. According to the paper, 57% of eyes after lock-in with a distance target achieved a UDVA of 20/20 or better; 90% were 20/25 or better, and 100% 20/40 or better. After lock-in, 100% had a CDVA of 20/20 or better, and 86% had a postop UDVA the same or better than their preop CDVA. All eyes had a UDVA within 1 line of their preoperative CDVA, and 93% were within 1 D of spherical target. Ninety-three percent of eyes had 0.5 D or less refractive cylinder postop. The authors concluded that DMEK and cataract surgery with LAL implantation resulted in significantly better UDVA and refractive outcomes than standard monofocal lenses.
• Global and regional trends in the number of people visually impaired by cataracts from 2000–2020 were identified in a systematic review and meta-analysis of published population studies and “gray literature.” According to the paper published in the journal Eye, in 2020, 17 million people were blind from cataracts and 83.5 million had mild to severe vision impairment (MSVI) due to cataracts. Blindness due to cataracts increased nearly 30% since 1990, but the “age-standardized global prevalence of cataract-related blindness improved by –27.5%,” while MSVI increased by 7.2%. The authors reported that this “indicates that cataract treatment programs have been beneficial, but population growth and aging have outpaced their impact.” The authors advocated for more and “better-directed” resources to increase global capacity to deal with cataract surgery need.

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Product news

• NovaBay Pharmaceuticals and Eyenovia signed an agreement where NovaBay will market Eyenovia’s FDA-approved clobetasol propionate ophthalmic suspension, 0.05%, which is indicated for inflammation and pain following ocular surgery.

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