First Ophthalmic Spray for Mydriasis Gets FDA Approval

■ Eyenovia announced that the FDA has approved Mydcombi (tropicamide and phenylephrine hydrochloride ophthalmic spray 1%/2.5%) for inducing mydriasis for diagnostic procedures and in conditions where short-term pupil dilation is desired. Mydcombi, which is the first approved fixed-dose combination of tropicamide and phenylephrine in the United States, is administered via Eyenovia’s proprietary Optejet microdose delivery device. Mydcombi is the first product approved by any regulatory agency to use the Optejet platform.

“The use of eye dropper bottles has presented challenges for dosing in ophthalmologic settings in millions of patients. We can do better now using sophisticated micro-array print delivery with physiologic dosing that is similar to the natural tear film volume,” Sean Ianchulev, MD, MPH, founder and chairman of Eyenovia’s board of directors, said in a news release.

Norlase Receives 510k Clearance and CE Mark for Echo Laser

■ Norlase announced that it received both FDA 510k clearance and CE Mark approval for its Echo green pattern laser photocoagulator, a portable scanner and laser that is integrated into a single delivery device that attaches to compatible slit lamps.

“The launch of Echo as the first and only truly portable pattern scanning laser brings a new paradigm to ophthalmologists who treat retina and glaucoma conditions,” Oliver Hvidt, CEO and cofounder of Norlase, said in a news release. Firas Rahhal, MD, an early adopter of the Echo pattern laser also said in a news release, “It provides excellent power and good uptake, even when used at lower power settings. The visualization on the slit lamp delivery is excellent, and in 1 of the cases I performed, this was true despite the presence of significant cataract.” Dr. Rahhal is a partner at Retina-Vitreous Associates Medical Group in Los Angeles.

Regenxbio Reports Positive Q1 2023 Financial Status and Operational Highlights

■ Regenxbio announced updates from its eye care collaboration with AbbVie to develop and commercialize a potential 1-time gene therapy for the treatment of chronic retinal diseases, as well as its first-quarter 2023 financial status. The updates include the transfer of the Investigational New Drug (IND) applications to AbbVie for all ongoing clinical trials and the expansion of the ATMOSPHERE and ASCENT pivotal trials for the treatment of patients with wet age-related macular degeneration (AMD) using subretinal delivery to support new global registration plans. As part of the IND transfers, the investigational gene therapy RGX-314 has been renamed ABBV-RGX-314. ABBV-RGX-314 is currently being evaluated in 9 ongoing clinical trials in the United States and Canada.

“REGENXBIO is well positioned for a transformative year, with multiple clinical milestones and updates anticipated in 2023. Based on the encouraging safety and clinical profiles, we believe ABBV-RGX-314 has the potential to be a highly differentiated product for millions of patients,” Kenneth T. Mills, the company’s president and CEO, said in a news release.

C. Light Receives FDA 510(k) Clearance for Retinal Eye Movement Monitor

■ C. Light Technologies announced that its device, the Retitrack, has been cleared for marketing following review of its 510(k) application by the FDA. The Retitrack is a monocular, tabletop eye-movement monitor that is intended for recording, viewing, measuring, and analyzing temporal characteristics of fixation and saccadic responses when viewing a visual stimulus.

The Retitrack is the first retinal eye-movement monitor cleared for use in health care. The device operates by recording 10-second, high-resolution retinal videos at the photoreceptor level, allowing for quantification of eye motion down to 0.1 degrees. Its accompanying software extracts and analyzes both fixation and saccadic eye movements in real time and generates a comprehensive summary report for clinical interpretation.

“With our novel technology, we’ve unlocked the potential of 1 of the smallest motor movements in the human body, offering invaluable data that will drive the future of clinical care,” Christy Sheehy-Bensinger, PhD, CEO, and cofounder of Retitrack said in a news release.

Retinal Tissue and Microvascular Loss May Be Biomarker of COVID-19 Severity

■ A Shiley Eye Institute study revealed that retinal tissue and microvascular loss may be a biomarker of COVID-19 severity. The study investigated the hypothesis that permanent capillary damage may underlie long-term COVID-19 sequela by quantifying the retinal vessel integrity. Sixty-one eyes from 31 individuals were studied. Participants were divided into 3 subgroups: normal controls who had not been affected by COVID-19, mild COVID-19 cases who received outpatient care, and severe COVID-19 cases requiring intensive care unit admission and respiratory support.

Findings indicated that retinal volume was significantly decreased in the outer 3 mm of the macula in the severe COVID-19 group; total retinal vessel density was significantly lower in the severe COVID-19 group compared to the normal and mild COVID-19 groups; and the intermediate and deep capillary plexuses in the severe COVID-19 group were significantly lower compared to other groups. Researchers say further monitoring of the retina in COVID-recovered patients may help expand understanding of COVID-19 sequelae.

New AI Company Uses Eye Images to Detect and Prevent Disease

■ Ascertain, a collaboration between Aegis Ventures and Northwell Holdings, announced that it has launched Optain, an artificial intelligence (AI) company that enables early identification and disease prevention through retinal imaging. With a $12 million investment, Optain is the first company launched by Ascertain. Optain uses the eye as a gateway to monitor whole-person health via its AI-enabled portable retinal camera that facilitates screening of more than 140 eye and systemic conditions, in the early stages of development.

“By harnessing the tremendous insight that can be gained through retinal scanning and combining that with innovative AI, Optain’s technology represents enormous potential to improve the manner and timeliness in which we can diagnose and treat disease,” Richard Braunstein, MD, senior vice president and executive director of ophthalmology at Northwell Health, said in a news release.

FDA Accepts Application for Vabysmo for the Treatment of RVO

■ Genentech announced that the FDA has accepted the company’s supplemental Biologics License Application (sBLA) for Vabysmo (faricimab-svoa), for the treatment of macular edema following retinal vein occlusion (RVO). Vabysmo targets and inhibits 2 disease pathways linked to retinal conditions by neutralizing angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A). The sBLA is based on results from the phase 3 BALATON and COMINO studies that demonstrated treatment with Vabysmo provided early and sustained improvement in vision, meeting the primary endpoint of noninferior visual acuity gains at 24 weeks compared to aflibercept. The BALATON and COMINO studies are ongoing, and data from weeks 24 to 72 will assess the potential of Vabysmo to extend dosing intervals up to every 4 months.

“If approved, this would be the third indication for Vabysmo, the first bispecific antibody available for the treatment of retinal conditions that can cause blindness,” Levi Garraway, MD, PhD, chief medical officer and head of global product development for Genentech, said in a news release.

Study Shows OpRegen’s Potential to Slow, Stop, or Reverse GA

■ Results from a phase 1/2a clinical study of OpRegen (RG6501) were presented at ARVO 2023. According to the presentation, there is preliminary evidence of durable anatomic and functional improvements following administration of OpRegen cells; extensive OpRegen surgical bleb coverage of areas of GA may be critical for optimizing patient outcomes, and OCT imaging with segmentation analysis is advantageous in assessment of retinal integrity after OpRegen treatment. The study is an open-label, single-arm, multicenter, dose-escalation trial evaluating a single administration of OpRegen delivered subretinally in patients with bilateral geographic atrophy (GA). Twenty-four patients were enrolled into 4 cohorts.

Eyal Banin, MD, PhD, director of the Center for Retinal and Macular Degenerations in the department of ophthalmology at Hadassah-Hebrew University Medical Center, delivered the presentation on behalf of Roche and Genentech. In a news release, Dr. Banin said, “These data further highlight the potential for a single dose of OpRegen to provide significant clinical outcomes for patients in a disease with a tremendous unmet need.”

OpRegen is being developed under an exclusive worldwide collaboration between Lineage Cell Therapeutics, Roche, and Genentech.

Nanoscope Presents RESTORE RP Results at ARVO

■ Nanoscope Therapeutics announced that key data from its phase 2b RESTORE clinical trial of MCO-010 for the treatment of RP, were presented at ARVO 2023. In the RESTORE trial, 18 patients with severe vision impairment due to RP received a single intravitreal injection of MCO-010, while 9 received a sham injection.

Composite outcomes in key efficacy measures at 12 months included: 18 of 18 MCO-010 treated patients showed vision improvement in the multi-luminance Y-mobility test (MLYMT), the multi-luminance shape discrimination test (MLSDT), and in best corrected visual acuity (BCVA) compared to 5 of 9 receiving placebo; 17 of 18 MCO-010 treated patients showed vision improvement in MLYMT or BCVA compared to 4 of 9 receiving placebo; 16 of 18 MCO-010 treated patients demonstrated a 2 or more luminance level improvement in the MLYMT or MLSDT compared to 4 of 9 receiving placebo; and 14 of 18 MCO-010 treated patients showed vision improvement in the MLSDT or BCVA compared to 3 of 9 receiving placebo.

Toku’s Series A Financing Led by National Vision and Topcon

■ Toku announced the closing of its $8 million Series A preferred financing round. The financing was co-led by National Vision, Inc., and Topcon Healthcare. The investment round will help Toku accelerate development of technologies that use artificial intelligence (AI) to analyze retinal images for biometric markers linked to overall health and risk of cardiovascular events, stroke, and diabetes.

“Over 80% of cardiac events and diabetes-related blindness could be prevented by identifying risk and applying targeted interventions. We are building a future in which more people have affordable access to this critical health data — all from analyzing a retinal image. We are proud to gain the support of 2 companies that play essential roles in vision care and optical technologies worldwide,” Toku cofounder and CEO Ehsan Vaghefi, PhD, said in a news release.

Salvat Reveals Phase 3 Clobetasol Data at ARVO

■ Salvat Technologies announced the results of its phase 3 clinical trials of ophthalmic corticosteroid (SVT-15473 clobetasol 0.05%) for the treatment of inflammation and pain after ocular surgery, at ARVO 2023. The presentation, made by Andrew Schwartz, MD, included the pooled data of 2 phase 3 trials of clobetasol conducted between 2020 and 2021, at more than 40 sites across the United States. The trials involved 426 cataract surgery patients; 281 received clobetasol and 145 received a placebo. The trials demonstrated the efficacy and safety of this approach, with clobetasol proving effective in reducing inflammation and pain in post–ocular surgery patients. In addition to its efficacy and safety, clinical trials have shown that it has very low impact on intraocular pressure, and after a standard 14-day treatment course, there was no rebound effect and thus no need for a gradual decrease in dosage.

RetinAI Partners With Boehringer Ingelheim on GA Treatments Using AI

■ RetinAI Medical announced that it has partnered with Boehringer Ingelheim to improve patient outcomes in GA by combining RetinAI’s Discovery platform and AI tools with Boehringer Ingelheim’s research in retinal diseases. RetinAI’s AI tools for identifying novel biomarkers will be tested for the analysis of Boehringer Ingelheim’s imaging data sets from clinical studies and real-world evidence to identify additional novel biomarkers and predictors of disease progression.

“We are confident that this collaboration with Boehringer Ingelheim can pave the way to novel treatments that are better tailored to a patient’s disease to transform the lives of people living with retinal diseases,” said Carlos Ciller, PhD, CEO of RetinAI, in a news release.

Clearside Plans ODYSSEY Phase 2b Trial of CLS-AX in Wet AMD

■ Clearside Biomedical announced that it will proceed with ODYSSEY, its multicenter phase 2b clinical trial of CLS-AX (axitinib injectable suspension) in wet AMD. CLS-AX is a proprietary suspension of axitinib for suprachoroidal injection. The company plans to open the trial for enrollment this quarter and expects top-line results in Q3 2024.

“We are excited to advance our CLS-AX program, building on the positive data from our OASIS phase 1/2a trial, which showed that CLS-AX was well tolerated and demonstrated an excellent safety profile and promising data up to 6 months durability. We believe CLS-AX has the potential to reduce treatment burden in patients with wet AMD while maintaining visual acuity,” Clearside’s president and CEO George Lasezkay, PharmD, JD, said in a news release.

Faricimab TENAYA/LUCERNE Trial Data Shared at ARVO 2023

■ Faricimab, a dual angiopoietin-2/VEGF-A inhibitor, led to anatomic improvements, including absence of fluid in patients with wet AMD and a greater reduction in central subfield thickness (CST), according to research from the phase 3 TENAYA/LUCERNE trials presented at ARVO 2023. In the phase 3 TENAYA/LUCERNE trials, patients were randomly assigned to receive faricimab 6 mg up to every 16 weeks or aflibercept 2 mg every 8 weeks. The researchers found that patients in the faricimab arm experienced a greater reduction in CST compared with those in the aflibercept arm at week 12 (-145 µm vs -133 µm; P≤.0001). In addition, more patients in the faricimab arm experienced absence of subretinal fluid (SRF) and intraretinal fluid (IRF) at week 12 compared with those in the aflibercept arm (77% vs 67%; P≤.0001). Patients with SRF and IRF at baseline experienced absence of IRF and SRF faster and with fewer injections than patients treated with aflibercept.

Study Assesses Turnover Trends Among US Ophthalmologists

■ A study evaluating ophthalmologist turnover rates and associated workforce changes in the United States from 2014 through 2021, found that one-third of US ophthalmologists separated from at least 1 practice during the 7-year period. The research, published in Ophthalmology, leveraged data from 2 publicly available Medicare data sets.

Of 13,264 ophthalmologists affiliated with 3,306 unique practices, 34.1% separated from at least 1 practice between 2014 and 2021. Annual turnover ranged from 3.7% (2017) to 19.4% (2018), with an average rate of 9.4%. Factors associated with increased turnover included solo practice, practice location in the Northeast, and practice size — 2 to 4 members. Factors associated with decreased turnover included male gender, and greater than 5 years of practice. Of note, in the initial year of the COVID-19 pandemic (2020), annual turnover grew from 7.8% to 11.0%, then fell to 8.7% in the pandemic postvaccine period (2021).

Study Evaluates AI and Associated Risk of Racial Bias in Retinal Images

■ A study that analyzed whether converting a fundus photograph to a retinal vessel map (RVM) removes information relevant to self-reported race (SRR) in AI training, found that despite multiple attempts to constrain SRR-associated information in RVMs, AI was able to learn patterns associated with SRR. This suggests that biomarker-based approaches to training AI models do not necessarily remove the potential for racial bias in practice.

The study, which was published in JAMA Ophthalmology, and led by Aaron S. Coyner, PhD, Oregon Health and Sciences University, concluded, “These results suggest that preliminary preprocessing steps may not always be successful, and future work ought to ensure that as much attention is paid to potential sources of bias in preprocessing, as it is during the training of diagnostic models.”

Luxa Presents RPE Stem Cell Clinical Trial Update at ARVO

■ Luxa Biotechnology presented an update on the progress of a phase 1/2a clinical trial evaluating transplantation of RPESC-RPE-4W to treat dry AMD, at ARVO 2023. In vitro studies of RPESC-RPE-4W demonstrated expression of the complete repertoire of cell functions carried out by natural RPE cells including trophic factor release and phagocytosis, and subretinal implantation in an animal model of AMD showing how RPESC-RPE-4W engrafts into the native RPE layer to fully replace lost RPE cells, among other things. The cell product being used in the clinical trial — RPESC-RPE-4W — is a progenitor-stage RPESC-RPE obtained after 4 weeks of differentiation. The trial is being conducted at the University of Michigan Kellogg Eye Center.

Adverum Reports New Nonclinical Ocular Gene Therapy Data

■ Adverum Biotechnologies presented new nonclinical data on an intravitreal gene therapy for the treatment of GA secondary to dry AMD via expression of complement factor I (CFI) at the American Society of Gene & Cell Therapy 2023 annual meeting. Adverum also presented new research supporting the utility of its proprietary AAV vector platform in ocular gene therapy. Among the presentation highlights were: 7m8 and LSV1 capsids packaged with AAV-CFIco yielded robust intraocular human CFI levels in NHPs; and IVT administration of AAV-CFIco via both capsids was well tolerated, with no anti-inflammatory steroids used at any timepoint in the study. RP

Endogena Completes Enrollment of Phase 1/2a Trial of EA-2353 for RP

Endogena Therapeutics announced that it has completed patient enrollment ahead of schedule in its phase 1/2a trial of EA-2353, a first-in-class small molecule that selectively activates endogenous retinal stem and progenitor cells to potentially preserve and restore visual function. The trial has enrolled 14 patients with retinitis pigmentosa (RP) due to any pathologic genetic mutation and is being conducted across 5 US sites. The first patient started treatment in July 2022, and top-line interim data are anticipated in early 2024.

“There’s a tremendous enthusiasm surrounding our trial, and completing enrollment ahead of schedule has only been possible thanks to the invaluable contribution of the patients, their families, the investigators, and their study staff. We are all driven by the hope of finding a treatment for this rare and devastating disease,” Matthias Steger, PhD, MBA, CEO of Endogena Therapeutics, said in a news release.

Verana Publishes Research on Implications of RWD and DR Severity

Verana Health announced that its study demonstrating how deidentified real-world data (RWD) from electronic health records (EHRs) in medical registries can allow for a deeper understanding of data trends, patterns, or gaps has been published in the Journal of the American Medical Informatics Association. The goal of this study was to understand the instances in which disease severity is not specified using diagnosis codes alone and whether patterns existed for the missing data. Major findings of the study included that although disease severity for DR is routinely captured in EHR notes, nearly 20% of ICD-9 cases had unspecified DR severity. This significantly improved with the transition to ICD-10 codes with only 5% of clinical encounters with unspecified DR severity.

“Recognizing the associations between DR severity and other clinical and demographic characteristics through RWD will help enable investigators to build more accurate predictive models,” senior author of the study, Durga S. Borkar, MD, MMCi, said in a news release. Dr. Borkar is a vitreoretinal surgeon at Duke University Eye Center and a Verana Health medical advisor.

Ideaya Announces Positive Data for Metastatic Uveal Melanoma Treatment

Ideaya announced that it has observed encouraging clinical activity in the phase 2 clinical trial evaluating a combination of darovasertib and crizotinib in metastatic uveal melanoma (MUM) patients. The reported phase 2 clinical data are based on 20 first-line and 63 any-line patients enrolled in the darovasertib and crizotinib combination study at the expansion dose of 300 mg twice-a-day darovasertib and 200 mg twice-a-day crizotinib.

“The observed efficacy in first-line MUM patients — including confirmed overall response rate of 45% and median progression-free survival of ~7 months — is clinically significant and represents a potential paradigm shift for treating MUM patients. The interim data for the darovasertib and crizotinib combination treatment in MUM suggests a compelling clinical efficacy and tolerability profile,” Meredith McKean, MD, MPH, director of melanoma and skin cancer research at Sarah Cannon Research Institute, said in a news release.

Concussion Tied to Structural Changes in Retina and Optic Nerve

Head trauma may have a significant impact on long-term visual and eye health, according to a study presented at ARVO 2023. Rajeev S. Ramchandran, MD, MBA, and colleagues from the University of Rochester Medical Center in Rochester, NY, investigated subconcussive head trauma, concussions, and history of concussions to determine if there was a correlation with functional changes in the optic nerve and retina.

The researchers assessed male college athletes from 1 school at preseason, postseason, and 4 months postseason. The athletes were football players with a history of concussions, players without a history of concussions, and noncontact athletes such as runners and swimmers matched for age and sex.

Ramchandran and his team concluded, “Structural macular and optic nerve changes in football-related concussions may not be short-term. Even severe head impacts during a single season are associated with acute changes that may be more long term. These findings highlight the retina and optic nerve as important biomarkers for brain structure and function and suggest that head trauma may have significant impact on long term visual and eye health.”