Phase 3 results for preservative-free redness reliever
Bausch + Lomb announced publication of its Phase 3 study assessing the efficacy and safety of LUMIFY Preservative Free drops to relieve redness compared to regular LUMIFY. The study included 380 participants who received either LUMIFY Preservative Free or LUMIFY. Redness scores were assessed at 8 timepoints. The preservative-free option was found to be non-inferior to LUMIFY in reducing ocular redness in both primary and secondary endpoints. Safety was favorable for the preservative-free option and similar to regular LUMIFY. LUMIFY Preservative Free was launched in June 2025 in the U.S.
Enrollment complete in Phase 3 pivotal program for wet AMD treatment
EyePoint Pharmaceuticals announced that it completed enrollment in its Phase 3 pivotal program, specifically for the second of its two identical Phase 3 trials, evaluating DURAVYU (vorolanib intravitreal insert) for treatment of wet AMD. The second trial enrolled and randomized more than 400 patients in 7 months, which the company stated is “one of the fastest enrolling Phase 3 pivotal programs in wet AMD.” Currently, interim masked safety data is showing a safety profile consistent with other DURAVYU clinical trials. Topline data from the first of the Phase 3 trials is expected in mid-2026.
Dry AMD Phase 3 trial completes enrollment
Annexon Biosciences announced that it completed enrollment in its Phase 3 trial for vonaprument (ANX007) for treatment of dry AMD with geographic atrophy (GA). Topline data is expected in the second half of 2026. According to the company’s press release, vonaprument is a “first-in-kind, non-pegylated antigen-binding fragment (Fab) designed to block C1q locally in the eye with an intravitreal formulation.” It is thought that vonaprument will have a neuroprotective effect, which was demonstrated in a Phase 2 trial. The company reported that vonaprument is “the only investigational therapy for dry AMD with GA to show significant vision preservation based upon best corrected visual acuity (BCVA) and low luminance visual acuity (LLVA).” It has received a Priority Medicine designation in Europe and a Fast Track designation in the U.S.
Study: 24-month data confirm durability of dry eye procedural treatment
The data from the third phase of a randomized controlled trial assessed the TearCare System (Sight Sciences) and manual meibomian gland expression in patients with meibomian gland disease. Patients were randomized to receive the heat therapy and a second treatment at month 5 with follow-up for an additional 19 months. According to the study, participants could be retreated if tear break-up time was within 2 seconds of their baseline and if ocular surface disease index scores increased by 15 points compared to the previous visit. This phase of the study included 166 participants. All signs and symptom measures (tear break-up time, meibomian gland secretion score, and ocular surface disease index) were statistically significantly above baseline at all timepoints (6, 9, 12, 15, 18, and 24 months). Thirty-two participants required retreatment at a median timepoint of 8 months. Ninety-two percent of participants were retreatment-free at 6 months. The authors concluded that this heat therapy with manual expression could provide durable relief from dry eye signs and symptoms. The pre-print study is online in the journal of Optometry and Vision Science. In a separate press release, Sight Sciences also announced an assessment of cost effectiveness of TearCare compared to cyclosporine 0.05% for treatment of moderate to severe meibomian gland disease-associated dry eye. This analysis, published in Expert Review of Pharmacoeconomics & Outcomes Research, according to the company, “demonstrated that TearCare is not only associated with greater health utility over time but also resulted in significant cost savings compared to CsA, offering a more efficient and patient-centric approach to treating this common ocular disease.” More specifically, the company stated that TearCare was associated with lower per-patient annual costs ($4,916) compared to cyclosporine ($5,819) and higher quality-adjusted life years scores (0.76 compared to 0.74, respectively).
Partnership and acquisition news
- Boehringer Ingelheim and Re-Vana Therapeutics announced their strategic collaboration and license agreement to develop first-in-class extended-release therapies for eye diseases. According to the press release, Boehringer Ingelheim has four assets in Phase 2 trials, and Re-Vana has a focus on drug delivery technologies that could lower treatment burden and increase compliance. The press release stated that there will be joint oversight of Re-Vana’s feasibility and development for extended-release programs, and Boehringer Ingelheim will be responsible for clinical development, regulatory approval, and global commercialization.
- Opus Genetics and the Global RDH12 Alliance have partnered to advance Opus’ gene therapy program that is focused on retinol dehydrogenase 12 gene mutations, accelerating the development of OPGx-RDH12 as a potential treatment for Leber congenital amaurosis.
- Topcon Healthcare acquired Intelligent Retinal Imaging Systems (IRIS), a cloud-based retinal screening technology. It will be integrating IRIS into its Healthcare from the Eye initiative.
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 Salt Lake City, Utah, on August 21.
- 2026 ASCRS Annual Meeting: Hotel room blocks are open for the 2026 ASCRS Annual Meeting, taking place in Washington, D.C., April 10–13, 2026. The call for submissions is also ongoing until September 1. Submit an abstract and get involved in the 2026 ASCRS Annual Meeting.
Research highlights
- The safety and efficacy of orthokeratology, 0.04% atropine, and 0.01% atropine for myopia control in children age 8–15 years old over a 2-year treatment period was evaluated in a 3-arm, parallel-design, multicenter randomized controlled trial published in the journal JAMA Ophthalmology. Participants (n=209) entered the study with between –1 D and –4 D of refractive error. Atropine 0.01% or 0.04% was administered daily, or patients were randomized to receive overnight orthokeratology. In terms of those who completed 2-year follow-up, 48 received 0.01% atropine, 48 0.04% atropine, and 53 orthokeratology. Those in the 0.04% atropine group had a significantly reduced axial length increase compared to those in the 0.01% atropine group. There was a nonsignificant but clinically meaningful difference between the 0.01% atropine group and the orthokeratology group. The 0.04% atropine group experienced a higher risk for photophobia compared to the 0.01% group. The authors also noted that 26.4% of participants in the orthokeratology group had “slight” corneal fluorescein staining. The authors concluded that 0.04% atropine was more effective than 0.01% atropine or orthokeratology.
- IOL calcification was quantitatively assessed using anterior segment OCT, correlating findings with straylight measurements in a prospective observational clinical study published in the Journal of Cataract & Refractive Surgery. Healthy patients with homogenous IOL calcification had AS-OCT imaging with ANTERION (Heidelberg Engineering) that was quantified “using a custom image-analysis script.” Straylight was assessed using the C-Quant straylight meter, and a correlation between IOL opacity and straylight was analyzed. The authors found a significant correlation between straylight measurements on AS-OCT quantitative assessments of IOL calcification in vivo. The authors reported that the “technique may serve as a valuable diagnostic tool for evaluating IOL opacification and assist in surgical decision-making, particularly in borderline cases.”
Product news
- XIPERE (triamcinolone acetonide injectable suspension, Clearside Biomedical) received approval by Health Canada for treatment of uveitic macular edema. It is already approved for use in the U.S., Australia, and Singapore, and under review in China.
- TRYPTYR (acoltremon ophthalmic solution, Alcon) 0.003% is now available commercially in the U.S. It received FDA approval for the treatment of signs and symptoms of dry eye disease in May.
This issue of EyeWorld Weekly was edited by Stacy Jablonski, Liz Hillman, and Ellen Stodola.
EyeWorld Weekly (ISSN 1089-0319), a digital publication of the American Society of Cataract and Refractive Surgery (ASCRS), is published every Friday, distributed by email, and posted live on Friday.
Medical Editors: Sumit “Sam” Garg, MD, Chief Medical Editor, Mitchell Weikert, MD, Cataract Editor, Karolinne Rocha, MD, PhD, Refractive Editor, Julie Schallhorn, MD, Cornea Editor, Manjool Shah, MD, Glaucoma Editor
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