Initial Phase 3 results for dry eye disease therapy

Stuart Therapeutics announced initial Phase 3 results from its study evaluating ST-100 (vezocolmitide) as a treatment for dry eye disease. According to the company’s press release, the 29-day trial found that a significant proportion of patients exhibited a more than 10 mm improvement from baseline in Schirmer’s tear scores. This Schirmer’s responder rate exceeded the Phase 2 study’s outcome but did not reach statistical significance because the vehicle performed better than in the Phase 2 trial. The Phase 3 trial also saw a statistically significant fluorescein staining improvement at week 1, and the week 1 magnitude of stain improvement compared to vehicle was “greater than any reported result for any approved DED therapeutic or product,” the company reported. A statistically significant visual function improvement compared to placebo was achieved on day 2, supporting the fast-acting nature of ST-100. The company stated that these findings would guide its design for its second Phase 3 study. ST-100 is a novel drug class of collagen mimetic peptides derived from Stuart Therapeutics’ PolyCol technology platform, targeting and repairing damaged collagen with the intent to “[restore] homeostatic function on the ocular surface,” the company stated.

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Positive Phase 2 results for intravitreal implant for glaucoma and diabetic retinopathy

Perfuse Therapeutics announced Phase 2 results from two clinical trials evaluating PER-001, which it described as a first-in-class endothelin antagonist delivered in a slow-release intravitreal implant being investigated for glaucoma and diabetic retinopathy by improving retinal blood flow and preventing retinal cell death. In the Phase 2 trial with glaucoma patients, 2% of patients who received the low dose of PER-001 and 37.5% who received the high dose experienced a 7 dB or greater improvement in a pre-defined retina region of 5 test points compared to 0% in the control group at 6 months. The company stated that this was 8–14x more improvement than the natural history of the disease with currently available treatments. In addition, no patients in the PER-001 groups experienced a 7 dB or greater loss compared to 12.5% that experienced a 7 dB or greater loss in 6 months in the placebo group. In other words, “progressive vision loss reversed in glaucoma patients as optic nerve blood flow and structure improved,” according to the company. In the diabetic retinopathy Phase 2 study, there was improved function (contrast sensitivity, visual acuity, and visual field) in the treatment groups, as well as improved structure with improvements seen in macular ischemia index, macular leakage, and macular microaneurysms. According to the company’s press release, Phase 2b/3 trials are expected to begin later this year.

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Phase 1/2a results from allogenic cell therapy for geographic atrophy

Lineage Cell Therapeutics announced its 36-month results from its Phase 1/2a clinical trial evaluating RG6501 (OpRegen) in patients with geographic atrophy. According to the company’s press release, a single subretinal administration of the allogenic retinal pigment epithelial (RPE) cell therapy resulted in retinal structure improvements that persisted out to 3 years. There were also anatomical and functional improvements. More specific findings included a mean change in BCVA among treated eyes (n=10) that completed the 3-year follow-up, and patients with extensive OpRegen cell therapy coverage of their atrophic areas saw a greater effect (mean BCVA change was +9.0 ETDRS letters at 36 months compared to +7.4 ETDRS letters at 24 months). OpRegen is intended to “counteract RPE cell loss in areas of GA lesions by supporting retinal cell health and improving retinal structure and function.” The treatment is being developed with collaboration between Lineage Cell Therapeutics, Roche, and Genentech. A Phase 2a clinical study is ongoing.

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Phase 1 trial successful with oral treatment for non-proliferative diabetic retinopathy

Breye Therapeutics announced success in its Phase 1b clinical trial evaluating danegaptide, an oral treatment for non-proliferative diabetic retinopathy. According to the company’s press release, the treatment was found to protect against retinal capillary loss and vascular leakage. Danegaptide is a first-in-class small molecule that “stabilizes the vasculature and protects from cell-cell uncoupling, retinal capillary breakdown and vascular leakage caused by hyperglycemia,” the company reported. All patients in the trial (n=24) tolerated all dose levels, and there were no dose-limiting toxicities. The company thinks this data supports a Phase 2 study.

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ASCRS news and events

• Business of Refractive Cataract Surgery Summit: This course, taking place October 3–5, in Chicago, Illinois, along with its extensive, take-home Resource Library, will help practices gain the navigational tools needed to increase premium IOL adoption and lead patients effectively on their refractive surgery journey. Learn more.
• ASCRS Live!: This educational dinner series is heading to several cities across the U.S. in 2025. Registration is open for the next event in Seattle, Washington, on July 24.
• ASCRS Grand Rounds: A new episode of ASCRS Grand Rounds, featuring cases involving a challenging intraoperative cataract surgery complication and a referral for a corneal mass, is online now. Watch the episode, which is eligible for CME, here.
• 2026 ASCRS Annual Meeting: Hotel room blocks are now open for the 2026 ASCRS Annual Meeting, taking place in Washington, D.C., April 10–13, 2026.

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Research highlights

• A prospective, randomized clinical trial evaluated IOL rotational stability if the patient laid down for 1 hour or walked around within the first hour after femtosecond laser-assisted cataract surgery or refractive surgery with non-toric IOL implantation in the capsular bag. The study, published in the Journal of Cataract & Refractive Surgery, randomized 38 eyes of 36 patients into these two groups. Immediately after surgery (baseline), at 1 hour, and 1 day postop, a retroilluminated slit lamp image was taken and changes in IOL position were measured between 2 episcleral landmarks and the haptics of the IOL. The authors found that patients in the group that laid down had an IOL rotation of 1.80±1.80 degrees at 1 hour and 1.52±1.89 degrees at 1 day postop. The group that was allowed to walk around within the first postop hour had IOL rotation of 1.21±2.11 degrees at the 1-hour measurement and 1.51±1.69 at 1 day. The authors concluded that “early postoperative patient position does not seem to influence IOL rotational stability.”
• A systematic literature review and meta-analysis published in the British Journal of Ophthalmology sought to evaluate the risk of retinal detachment after refractive lens exchange (RLE) and after cataract surgery. The researchers identified 40 studies that met inclusion criteria, which included 20,264 eyes that had RLE and more than 8.5 million that had cataract surgery. In the RLE group, retinal detachment incidence within the first 12 months postop was 0.00016%, 0.0000% between 12–24 months, and 0.02312% at more than 24 months of follow-up. In the cataract surgery subgroup, the incidence was 0.01244% at more than 24 months of follow-up, and for those missing follow-up 0.00429%. The authors concluded that the incidence of retinal detachment after 24 months was double that after RLE compared to cataract surgery. It was a rare complication after cataract surgery, occurring in 1/1000 cases, and uncommon after RLE, occurring in 1/500 cases, the authors reported.

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Product news

• The Alcon Clareon PanOptix Pro IOL is now available in Canada.

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