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Lindsell discusses promising retinal therapeutics, such as at-home therapies, gene therapy, and devices like the Valeda light delivery system (LumiThera), which uses photobiomodulation and shows early promise in preventing geographic atrophy altogether.

CIME 2025: Luke Lindsell, OD, MD, on bridging innovation and practical care in retinal disease

Articles

Topline results from the Magnify phase 2 clinical trial of oral zervimesine show 28.6% slower geographic atrophy lesion growth compared with placebo.

Oral zervimesine reduced GA lesion growth in phase 2 study from Cognition Therapeutics

Boehringer Ingelheim announced that the phase 2 clinical studies will investigate a potential first-in-class oral compound and a highly specific antibody fragment for geographic atrophy.

Boehringer Ingelheim kicks off dual phase 2 clinical studies for geographic atrophy candidates

The LuxLife full range of vision intraocular lens is available in a range of cylinders spanning from +0.75D to +6.00D.

Bausch + Lomb's LuxLife IOL receives CE Mark approval in Europe

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Mitchell Jackson, MD, discussed laser scleral microporation from Ace Vision Group at the 2023 ASCRS annual meeting in San Diego.

ASCRS 2023: Laser scleral microporation from Ace Vision Group

Phase 2 clinical stage biotechnology company Galimedix Therapeutics has announced the completion of the single ascending dose (SAD) portion of its phase 1 study assessing GAL-101, an oral therapy designed to treat Alzheimer disease, dry age-related macular degeneration (AMD), and glaucoma.

 The small molecule is specifically designed to target misfolded amyloid beta (Aβ) monomers, according to a news release.

The next arm of the study, which includes multiple ascending dose, is   underway and is expected to be completed in late 2025.

“The successful completion of the single ascending dose part of our Phase 1 trial with oral GAL-101 marks an important step forward in our clinical development,” Hermann Russ, MD, PhD, cofounder and chief scientific officer of Galimedix, said in the release. “The data we have seen so far support the safety, tolerability and pharmacokinetic profile we anticipated and reinforce the potential of GAL-101 as an oral therapy for CNS [central nervous system], eye and other diseases associated with amyloid beta pathology, including Alzheimer’s disease. We are proceeding according to plan and are now moving confidently into the next parts of the study, which we are on track to complete later this year.”

In the SAD section of the study, 40 healthy patients were randomly assigned 3:1 to receive either GAL-101 or placebo capsules. GAL-101 was shown to be well tolerated with a highly favorable safety profile, while also demonstrating “an excellent pharmacokinetic profile, strongly supporting the planned oral administration route,” the release said.

The phase 1 trial is ultimately designed to enroll up to 120 patients and is planned to address all relevant aspects required to initiative the planned oral phase 2 studies in Galimedix’s key indications—Alzheimer disease, dry AMD, and glaucoma.

 While the phase 1 trial is ongoing, the company is also conducting a phase 2 eDREAM clinical trial with GAL-101 eye drops for dry AMD. The eDREAM study is expected to complete recruitment in less than a year, according to the release.

In targeting misfolded Aβ monomers, GAL-101 works to prevent the formation of toxic Aβ oligomers and protofibrils. “Many studies have indicated that these Aβ aggregates are a major underlying cause of neurodegenerative diseases of the eye, and recent approvals of anti-Aβ drugs have also validated them as a key target in Alzheimer’s disease,” the release stated. Preclinical testing of GAL-101 demonstrated the compound’s ability to prevent and eliminate all forms of toxic Aβ species while leaving healthy Aβ forms intact. GAL-101 also demonstrated potential for neuroprotection and for symptomatic alleviation of Alzheimer disease in preclinical models of the disease.

A previous phase 1 study assessed GAL-101 in the form of an eye drop and demonstrated excellent safety and tolerability. GAL-101 in its oral form has shown no antibody-specific immunological side effects, such as amyloid-related Imaging abnormalities, low systemic toxicity, strong storage stability, and “easy and inexpensive manufacturing,” the release stated. GAL-101’s efficacy in protecting neuronal retinal cells from toxic damage has otherwise been demonstrated in other relevant ophthalmic preclinical models.

Galimedix Therapeutics completes single ascending dose part of phase 1 study with oral small molecule, GAL-101, an amyloid beta aggregation modulator. News release. Galimedix Therapeutics. May 6, 2025. Accessed May 7, 2025. 

https://finance.yahoo.com/news/galimedix-therapeutics-completes-single-ascending-120000532.html?guccounter=1&guce_referrer=aHR0cHM6Ly93d3cuZ29vZ2xlLmNvbS8&guce_referrer_sig=AQAAACgUyRp_ORP9y6GDtKFlLbKePeh5zKVSrjSvIw7kcT4Monkji7eUMIRf96oXxcHyQAdLkj2JTjeIxo5cPTiwmesFTrPWy8AuSH76fm0UwY_Q13QqpExryO9cA_HAT1MUnnSRXSD0OY5OM5id43VqIIspgFo-R7BqlO-wgaA_9QfY

The trial assesses GAL-101 as an oral therapy designed to treat Alzheimer disease, dry age-related macular degeneration, and glaucoma.

Galimedix Therapeutics completes single ascending dose portion of phase 1 trial assessing GAL-101

Yi Ni Toh, PhD, and colleagues reported that head-scanning training for patients with hemianopia improved the rates of detection of blind-side hazards, speed of detection of blind-side hazards, and safety during virtual driving. She reported their findings at the Association for Research in Vision and Ophthalmology 2025 Annual Meeting in Salt Lake City, Utah.

The investigators, who are from the Schepens Eye Research Institute of Mass Eye and Ear, Department of Ophthalmology, Harvard Medical School, Boston, Massachusetts, also reported that the benefits of the training, driven by improved blind-side scanning, lasted for more than a month.

“The results demonstrated the potential of our novel training to address deficits in blind-side hazard detection,” they emphasized because of the impairments experienced by patients with hemaniopia.

They explained that homonymous visual field loss (HVFL) impairs blind-side hazard detection due to limited visual field,

 the compensation for which mandates large head scans to the blind side. However, some patients may fail to scan adequately, which increases the risk of collisions.

A previous pilot study reported that real-time auditory reminder cues to scan promoted larger head movements before arriving at intersections and better hazard detection.

A total of 15 patients (median age, 54 years; range, 39-67) participated in this trial. They underwent a preevaluation, 3 training sessions on a driving simulator, and evaluations 1 week and 1 month following their performance on the simulator.

Sixty percent of patients had hemianopia and 40% had quadrantanopia; in 60% of patients, the cause of the HVFL was a stroke.

While using the driving simulator, the participants controlled the speed and steering of the vehicle while driving on city streets. They were tasked with driving with a GPS and honking when they detected a motorcycle. The motorcycles appeared at 38% of intersections on each drive; they approached from the left or right and were visible at an eccentricity between 50 ° and 60 °, Toh recounted.

She reported that the virtual training improved the blind-side hazard detection rate, speed, and safety. Specifically, the training increased blind-side detection compared with baseline (P < .0001); these gains were sustained out to 1 month and approached the participants’ vision level on their sighted side (

The speed with which the participants detected hazards also increased on the blind side (

 < .001). As with detection of hazards, the improvements in speed were sustained at 1 month and were near to those on the sighted side (

The training also improved blind-side detection safety (

 < .0001). The gains were sustained at 1 month and approached the levels on the sighted side (P > .4). The investigators defined safe detection as that occurring with sufficient time to execute a safe maneuver.

The investigators commented, “Training improved the blind-side detection by reducing the scanning errors, ie, failing to scan and not scanning far enough, and increased the scan coverage on the blind side.”

The results conformed to the American Association of Highway and Transportation Officials sight triangle standard, ie, at 40 mph, drivers should be able to see 102 meters (445 feet) down the major road onto which they are turning.

Toh explained that before the participants engaged in training, the blind-side hazards were detected when the scans reached this distance but often missed when they did not. Training increased blind-side scan coverage, calculated by converting the scan magnitude based on the driver’s distance to the intersection at the onset of the scan.

1. Bowers AR, Ananyev E, Mandel AJ, Goldstein RB, Peli E. Driving with hemianopia: IV. Head scanning and detection at intersections in a simulator. 

 2014;55(3):1540–1548. doi:10.1167/iovs.13-12748

2. Swan G, Savage SW, Zhang L, Bowers AR. Driving with hemianopia VII: predicting hazard detection with gaze and head scan magnitude. 

3. Xu J, Emmermann B, Bowers AR. Auditory reminder cues to promote proactive scanning on approach to intersections in drivers with homonymous hemianopia: driving with hemianopia, IX.

 2022;140:75-78. doi:10.1001/jamaophthalmol.2021.5007

Investigators reported that the benefits of the training for patients with hemianopia, driven by improved blind-side scanning, lasted for more than a month.

Conference

ARVO 2025: Head-scanning training program improves blind-side detection during virtual driving for hemianopia patients

supports the finding that myopia control gains with CooperVision’s MiSight 1 day dual-focus soft contact lenses are sustained after treatment, with eye growth aligning with that of untreated, age-matched populations.

 Results from the study indicated that there was no rebound effect with the contact lenses, according to a news release.

Additionally, after treatment cessation, eye growth returned to age-expected levels and the accumulated myopia control treatment gains were retained over the following 12 months after treatment was ceased.

“Eye care professionals (ECPs) have embraced the importance of myopia control in children, and we are starting to see this reflected in prescribing behavior around the world,” said Paul Chamberlain, senior director of research programs at CooperVision and the study’s lead author, in the release. “To turn the tide on childhood myopia, ECPs must be confident in an intervention that not only slows progression but makes long-term treatment worthwhile. MiSight 1 day clearly demonstrates these benefits, allowing ECPs to prescribe with confidence for both immediate and lasting impact.”

The study evaluated participants who completed the 6-year MiSight 1 day clinical trial, including both the cohort who wore the lenses for all 6 years and the cohort who switched from single-vision to the MiSight lenses for the final 3 years, for an additional year following treatment cessation.

The study included 83 participants, with 38 participants with 6 years of prior treatment (referred to as T6) and 40 receiving treatment during study years 4 to 6 (referred to as T3). Axial length and cyclopleged spherical equivalent refractive errors were also monitored annually for 7 years. The study that was conducted in years 1 to 3 (NCT01729208) was a multicenter, double-masked, controlled clinical trial which myopic children aged 8 to 12 years were randomly assigned to wear single-vision control lenses (Proclear 1 day; CooperVision) or MiSight lenses. Participants were then all assigned MiSight lenses in an open-label trial using the same clinical sites in Europe, Southeast Asia, and North America. After completing part 2 of the study, subjects from both cohorts were invited to participate in part 3, a bilateral, open-label trial in year 7 in which all eyes were refit into the Proclear lenses. Visits for part 3 commenced, on average, 2 weeks after the end of part 2. Follow-up visits were scheduled for the 6-month mark and the final visit, which was 1 year after the start of the washout period.

During the untreated year 7, these annual axial growth and refractive changes were reported at 0.09 ± 0.09 (T3) and 0.10 ± 0.10 mm/y (T6), and −0.23 ± 0.36 (T3) and −0.21 ± 0.40 D/y (T6), respectively, with each slightly greater than observed during the previous year of treatment (0.07 ± 0.12 [T3] and 0.08 ± 0.07 mm [T6], and −0.04 ± 0.34 [T3] and −0.13 ± 0.42 D [T6]). Year 7 progression was less for the older (11 to 12 at baseline, −0.17 ± 0.40 D/0.05 ± 0.07 mm) than the younger (8 to 10 at baseline, −0.26 ± 0.36 D/0.13 ± 0.10 mm) subgroup. Years in treatment (3 vs 6) did not influence posttreatment growth or progression.

“The conclusion that post-treatment eye growth and myopia progression was unaffected by the 3 or 6 years of prior treatment centers on the extrapolation of measured untreated growth from the initial control cohort using average growth and progression rates observed in untreated myopic eyes,” the study authors stated. “Conclusions would be better supported if the control group had been retained for 7 years. However, because of the success revealed after the first 3 years of the MiSight 1 day clinical trial, it was considered to be unethical and impractical to retain the control group for additional years of the study.”

Retention of myopia control with MiSight 1 day contact lenses post treatment supported by peer-reviewed journal. News release. CooperVision. May 5, 2025. Accessed May 5, 2025. https://coopervision.com/practitioner/ecp-viewpoints/eyes-coopervision/retention-myopia-control-misight-1-day-contact-lenses#:~:text=The%20results%20indicated%20that%20there,12%20months%20after%20treatment%20ceased.

Chamberlain P, Hammond D, Bradley A, et al. Eye growth and myopia progression following cessation of myopia control therapy with a dual-focus soft contact lens. 

Published online March 25, 2025. doi:10.1097/OPX.0000000000002244

After treatment cessation, eye growth returned to age-expected levels and the accumulated myopia control treatment gains were retained over the following 12 months after treatment was ceased.

New study supports retention of myopia control in CooperVision's MiSight 1 day contact lenses

Aldeyra Therapeutics has achieved primary end point in one of its phase 3 trials of reproxalap for the treatment of 

, which the company will include in the resubmission of the new drug application (NDA) for the therapeutic candidate.

 The dry eye chamber trial was statistically superior to the vehicle in terms of ocular discomfort and while the field trial missed statistical significance for the primary end point, it was consistent with previous field trials and will be submitted with the NDA submission as supportive data. The company intends to resubmit its NDA in mid-2025, pending a Type A meeting with the FDA.

​​“The dry eye chamber results announced today are representative of a number of clinical trials that highlight the potential rapid clinical effect of reproxalap on reducing ocular discomfort,” Todd C. Brady, MD, PhD, president and chief executive officer of Aldeyra, said in a press release. “With no notable baseline differences across treatment arms and highly statistically significant results in favor of reproxalap over vehicle, Aldeyra believes the data potentially address the FDA feedback in the Complete Response Letter received last month and we look forward to meeting with the FDA shortly.”

The phase 3 trial of 0.25% reproxalap was randomized, double masked, and vehicle controlled. In the chamber trial, reproxalap achieved statistical significance for the prespecified end point of ocular discomfort (n = 58) compared with the vehicle (n = 58). The measure was an ocular discomfort symptom score (0-100) from 80 to 100 minutes following chamber entry (LS mean difference [95% CI] -6.5 [-10.5, -2.5]; 

No safety signals or treatment-related discontinuations were reported in either of the recently completed clinical trials. Investigators observed reproxalap to be well tolerated. The most commonly reported adverse event was mild and transient instillation site discomfort, which is consistent with prior clinical trials.

The FDA accepts chamber trial results per its draft guidance for dry eye drug development, but they are rare for dry eye clinical trials. Also called a challenge-model trial, this trial design uses a controlled chamber to regulate temperature, air flow, humidity, and other environmental factors.

 All other dry eye disease therapeutics on the market today have used a more traditional environmental exposure study, marking Aldeyra’s trials as particularly unique.

Because this data contains no notable differences in baseline scores across treatment arms, Aldeyra hopes it will address the concerns listed by the FDA in the 

Complete Response Letter it received in April 2025

most recent NDA submission in November 2024

. At the time, the FDA had found no manufacturing or safety issues with reproxalap, but stated that the submission “failed to demonstrate efficacy in adequate and well controlled studies in treating ocular symptoms associated with dry eyes” and that “at least one additional adequate and well controlled study to demonstrate a positive effect on the treatment of ocular symptoms of dry eye” should be conducted. Additionally, the FDA expressed concerns that the data from the previous chamber trial may have affected interpretation of the results.

“Pending positive results from the ongoing clinical trials and discussions with the FDA, we look forward to a potential NDA resubmission mid-year 2025,” Brady said in a press release at the time of the CRL in April. “Reproxalap remains the only late-stage topical ocular therapy suitable for chronic administration to have potentially demonstrated acute reduction in ocular redness, as well as reduction in ocular discomfort, highlighting rapid and broad activity for both the signs and symptoms of dry eye disease.”

1. Aldeyra Therapeutics achieves primary endpoint in phase 3 dry eye disease chamber trial of Reproxalap and plans NDA resubmission. Aldeyra Therapeutics. Press release. May 5, 2025. Accessed May 6, 2025. 

https://ir.aldeyra.com/news-releases/news-release-details/aldeyra-therapeutics-achieves-primary-endpoint-phase-3-dry-eye-0

2. Harp MD. FDA issues complete response letter to Aldeyra Therapeutics for resubmitted new drug application of reproxalap. 

https://www.optometrytimes.com/view/fda-issues-complete-response-letter-to-aldeyra-therapeutics-for-resubmitted-new-drug-application-of-reproxalap

3. Dry eye: developing drugs for treatment - guidance for industry. FDA. December 14, 2020. Accessed May 6, 2025. 

https://www.fda.gov/media/144594/download

New data for 0.25% reproxalap was announced by Aldeyra Therapeutics, supporting the company’s NDA resubmission for the treatment of dry eye disease.

Pipeline

Aldeyra Therapeutics hits primary end point in 1 of 2 phase 3 trials for reproxalap

Dr Jacob Lang discusses pharmacological presbyopia correction at the 2025 Controversies in Modern Eye Care meeting

CIME 2025: Pharmacologic presbyopia correction provices a new hope for flexibility for patients

 meeting in Los Angeles, California, which took place May 4, 2025, Jacob Lang, OD, FAAO, director of dry eye services at Associated Eye Care in the Twin Cities metro area of Minnesota, shared his perspective on one of the most exciting advancements in vision care: pharmacologic correction for 

According to Lang, pharmacologic options for presbyopia represent a long-awaited shift in how eye care professionals can help patients manage age-related near vision loss. What excites him most is the flexibility these therapies offer. “Pharmacologic correction gives patients the freedom to use it when they need it," he explained. “It’s about enabling lifestyle choices and offering convenience in the busy presbyopic years.”

This shift isn’t just about avoiding reading glasses; it's about empowering patients with control over their vision, particularly those who lead dynamic personal and professional lives.

Lang emphasizes motivation as the key driver when choosing candidates for pharmacologic treatment. “We're looking for patients who are motivated to do something different,” he said. These patients often want more freedom in their daily routines and are willing to try new options to achieve it. The ideal candidate is one who values the flexibility these therapies offer and has realistic expectations about their use.

Lang also highlighted a surprising barrier: provider awareness. “One of the biggest challenges is that many doctors aren’t familiar with the available pharmacologic options,” he said. As a result, patients may not even be offered these treatments. For Lang, continued professional education and openness to innovation are critical. “We need to embrace new tools and understand how they can benefit our patients.”

Finally, Lang reminded attendees that any pharmacologic intervention must be grounded in sound clinical judgment. “We have to treat the entire eye, front to back. From ocular surface to retina, we’re still the doctor.” He stressed that presbyopia drops are, after all, pharmaceuticals and should be managed with the same diligence as any other ocular therapy.

CIME 2025: Pharmacologic presbyopia correction provides new hope for flexibility for patients

Dr Dilsher Dhoot speaks on retinal disease and emerging therapies at Controversies in Modern Eye Care 2025

Dilsher Dhoot, MD, FASRS, expresses excitement for emerging retinal therapies, improved comanagement

2025 Controversies in Modern Eye Care conference

, Dilsher Dhoot, MD, FASRS, of California Retina Consultants shared his forward-looking perspective on developments in 

 management, highlighting both recent breakthroughs and promising innovations on the horizon. The Controversies in Modern Eye Care meeting took place May 4, 2025, in Los Angeles, California.

“We’re in a golden era of retina,” Dhoot began, referencing a wave of recent FDA approvals and a pipeline rich with potential. He expressed particular enthusiasm about gene therapy and tyrosine kinase inhibitors, which offer new hope for patients needing longer treatment durability. These therapies, he noted, are "just around the corner" and could significantly extend treatment intervals compared with existing regimens.

The evolution in geographic atrophy management

. “We haven’t traditionally had therapy for GA, but now we do,” he noted, referring to the 2 FDA-approved treatments that have emerged in recent years. While these agents can slow atrophy progression, he emphasized that this is just the beginning.

“The pipeline will include more durable agents, and possibly more effective ones,” he said. He also stressed the growing role of artificial intelligence (AI) in identifying patients who may benefit most from current and future treatments. AI-driven imaging and biomarker identification are already showing promise in personalizing care and improving outcomes.

Optometry’s pivotal role in retinal health

Dhoot praised optometrists for their role in early detection and referral. “You do a great job identifying these patients,” he said, emphasizing that timely referral doesn’t signify imminent vision loss. “Being sent to retina is not a sentence to blindness.”

He encouraged optometrists to reassure patients about intravitreal injections, noting that they’re less daunting than they sound. “The eye is a very easy place to inject,” he said, and with current therapies, patients can retain—and sometimes even improve—vision.

Referral thresholds and collaborative care

Dhoot urged optometrists to consider a low threshold for referral, particularly when diagnostic uncertainty exists or interventions are available. “For myself, if I’m not sure, I refer,” he said. While conditions like intermediate age-related macular degeneration or mild nonproliferative diabetic retinopathy can sometimes be monitored, he stressed the importance of access to advanced imaging and clear communication between providers.

As the field of retina rapidly advances, collaboration between optometry and retina specialists will remain crucial in delivering optimal patient care.

Dilsher Dhoot, MD, FASRS, shares his forward-looking perspective on developments in retinal disease management, highlighting both recent breakthroughs and promising innovations on the horizon.

Mitchell Jackson, MD

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