Phase 2 results for autoimmune-related dry eye disease immunomodulator

Iolyx Therapeutics announced topline data from its Phase 2 trial evaluating ILYX-002, a topical immunomodulator for treatment of moderate to severe dry eye disease associated with systemic or inflammatory conditions. According to the company’s press release, the investigational drop achieved a “clinically meaningful trend in the primary endpoint of total conjunctival staining and a statistically significant finding on the secondary endpoint of total corneal staining.” The company also noted a rapid onset of action with both staining endpoints being achieved at day 15 and extending out to day 57. From a quality of life standpoint, the company stated that patients reported 10- to 20-point improvements in symptoms and quality of life sub-scores. There were no treatment-related serious adverse events. The company is planning a Phase 3 study that is expected to begin later this year.

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JCRS astigmatism working group publishes two papers

The Journal of Cataract & Refractive Surgery (JCRS) formed a working group to provide consensus and clarity on the topic of astigmatism analysis. The goals of the group were to “(1) establish astigmatic reporting guidelines based on sound optical principles and (2) provide new astigmatism calculation tools that simplify the process and allow researchers to reliably calculate accurate and reproducible results.” The first paper published in the journal by the group defined astigmatism and provided information on the sources and measurement of astigmatism, discussed the population distribution of corneal astigmatism, the differences among corneal imaging technologies, the impact of the ocular surface, irregular corneal astigmatism, posterior and internal sources of astigmatism, and refractive astigmatism. The second paper provided the “recommended methodology for analyzing astigmatic outcomes,” which the authors wrote was “based on the optics of corneal and lenticular astigmatism, as well as contemporary vector analysis and statistical approaches.”

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FDA approves therapy for diabetic retinopathy

Susvimo (ranibizumab, Genentech) was approved by the FDA for treatment of diabetic retinopathy (DR), which is the third indication for this drug. Other indications include wet AMD and diabetic macular edema. The company reported that this is the “first and only FDA-approved continuous delivery treatment shown to maintain vision in people with DR with just one refill every nine months.”

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Enrollment closes for largest retinal trial of its kind to date

Ocular Therapeutix announced that enrollment for its second registrational trial evaluating AXPAXLI for treatment of wet AMD is closing this week. The company reported that this is the largest retinal tyrosine kinase inhibitor trial to date, with randomization of at least 555 participants. It is evaluating safety and efficacy of AXPAXLI dosed every 6 months compared to aflibercept (2 mg) dosed every 8 weeks. The primary endpoint is non-inferiority in mean change in BCVA from baseline between AXPAXLI and aflibercept at 56 weeks. The company’s first registrational trial completed its randomization in December, and topline results are expected in the first quarter of 2026.

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Enrollment complete for Phase 3 trial evaluating wet AMD treatment

EyePoint Pharmaceuticals announced that it has completed enrollment with more than 400 patients randomized into its Phase 3 trial evaluating DURAVYU for treatment of wet AMD. The company reported that this was “one of the fastest enrolling Phase 3 pivotal trials for wet AMD to date.” Topline data from this trial is expected in mid-2026. Its second Phase 3 trial is continuing enrollment with 60% of patients randomized and enrollment completion expected later this year.

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Rare Pediatric Disease Designation granted for treatment targeting several retinopathies

Ocugen received a Rare Pediatric Disease Designation from the FDA for OCU410ST, which it is developing as a treatment for ABCA4-associated retinopathies, which include Stargardt disease, retinitis pigmentosa 19, and cone-rod dystrophy 3. It already has an Orphan Drug Designation from the FDA and the European Medicines Agency.

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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 advanced-technology 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 Chicago, Illinois, on June 12.
• 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 interventional series published in the Journal of Cataract & Refractive Surgery sought to evaluate the visual outcomes of a non-diffractive EDOF IOL (AcrySof Vivity, Alcon) in patients with early dry AMD. Forty eyes of 40 patients were included in the study. According to the authors, UDVA and CDVA at 3 months postop were 0.12±0.07 and 0.10±0.10 logMAR, respectively. UIVA and DCIVA were 0.25±0.09 and 0.12±0.09 logMAR, respectively, and UNVA and DCNVA were 0.23±0.10 and 0.19±0.15 logMAR, respectively. The authors also measured contrast sensitivity, finding no significant differences in this area, despite early dry AMD. The authors concluded that the lens provided “very good distance visual acuity with improved intermediate and near visual acuity” in this group of eyes.
• A prospective, observational, single-center cohort study of 129 eyes from 102 patients sought to determine the impact of lamellar splitting, which can occur during descemetorhexis creation in a DMEK procedure, on surgical outcomes. In the study, patients were divided into two groups depending on whether lamellar splitting occurred or not. If lamellar splitting did occur, the remnants, according to the authors were polished with irrigation/aspiration. The primary outcome was CDVA at 4 months postop. The authors found that lamellar splitting during DMEK did not have a significant impact on visual outcomes (postop CDVA in the splitting group was 0.12±0.12 logMAR, which was not significantly different than the non-splitting group [0.12±0.12 logMAR]). Central corneal thickness, thinnest corneal thickness, posterior corneal density, and endothelial cell loss were not different between the two groups; rebubbling rates also did not significantly differ. The authors concluded that polishing the remnants of Descemet’s membrane in cases of splitting intraoperatively could address the complication to optimize visual outcomes. This study was published in the journal Eye.

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