- Updates on trial and patient experience with artificial cornea
- Positive clinical trial update for Usher syndrome type 1B
- Positive topline data from Phase 2 study investigating DME and nAMD treatment
- First patient dosed in second Phase 3 trial evaluating drop for night vision disturbances
- Partnership and company news
- ASCRS news and events
September 12, 2025 • Volume 31, Number 35
Updates on trial and patient experience with artificial cornea
CorNeat Vision, which is developing the CorNeat KPro artificial cornea, announced updates for both its clinical trial and a “groundbreaking clinical achievement” for one of its patients. One patient, according to the company’s press release, had blinding corneal scarring from herpes zoster ophthalmicus. Eleven months after receiving the CorNeat KPro, this patient, who was not a candidate for a traditional corneal transplant, has 20/20 vision and “a remarkable aesthetic transformation,” with the eye looking natural and healthy,” according to the company’s press release. In addition, the company stated that its trial, which is designed to enable FDA 510(k) clearance and CE marking if successful, is at 50% enrollment. According to CorNeat, the trial will expand into U.S. centers in 2026.
Positive clinical trial update for Usher syndrome type 1B
AAVantgarde Bio provided an update on its Phase 1/2 trial investigating AAVB-081 for treatment of Usher syndrome type 1B. The data presented included the first 11 patients in the trial—5 receiving the low dose, 5 receiving the medium dose, and 1 receiving the highest dose. The trial update included four participants with at least 180 days of follow-up. These showed no drug-related serious adverse events or dose-limiting toxicities. More than 1 line of BCVA improvement was seen in the first four participants with 180+ days of follow-up, and the first two participants had more than 3 lines of improvement in low-light visual acuity. Microperimetry fixation stability improved in three out of these four participants. The dose-escalation trial is ongoing in its investigation of AAVB-081 for patients with retinitis pigmentosa associated with Usher syndrome type 1B.
Positive topline data from Phase 2 study investigating DME and nAMD treatment
Ashvattha Therapeutics announced positive topline data from its Phase 2 study of migaldendranib for treatment of DME and nAMD. The 40-week, multicenter, chronic dosing study assessed safety and efficacy of the subcutaneous VEGF receptor tyrosine kinase inhibitor that was covalently linked to a hydroxyl dendrimer. According to the company’s press release, migaldendranib is designed to “shut down VEGF expression in activated macrophages and microglia and hypoxic retinal pigment epithelial cells,” thereby reducing the need for anti-VEGF injections. Key findings in the study, according to the press release, were that the rate of annualized intravitreal injections in study eyes decreased from 8.4 per year to 1.6 per year (a 78.6% reduction), with an 83.4% reduction in the need for supplemental anti-VEGF injections compared to pre-study supplemental injections. The press release also noted a bilateral treatment effect even in eyes that did not receive subcutaneous migaldendranib; these eyes saw a decrease of annualized intravitreal injections from 8.3 to 0.9 per year. Mean change from baseline to week 40 was +6.1 ETDRS letters in BCVA and a –23.3 μm in central subfield thickness in eyes with DME. There were improvements in BCVA and CST in eyes with nAMD as well, according to the company. There were no treatment-related systemic or ocular serious adverse events.
First patient dosed in second Phase 3 trial evaluating drop for night vision disturbances
Opus Genetics announced that it has dosed the first patient in its second Phase 3 trial evaluating phentolamine ophthalmic solution 0.75%, for treatment for “chronic night driving impairment in keratorefractive patients with reduced mesopic vision.” This indication has a Fast Track designation from the FDA and is being conducted under a Special Protocol Assessment; there are no FDA-approved treatments for patients who have had keratorefractive surgery and experience night-vision disturbances. According to the company, the drop is designed to reduce pupil size in low-light conditions to decrease starbursts, glare, and halos, while maintaining contrast sensitivity. The positive results from the first Phase 3 study were announced in June. This second trial will enroll 200 participants.
Partnership and company news
- Topcon invested in Senseye, a company developing a mental health diagnostic platform that identifies disorders (such as PTSD, major depressive disorder, and generalized anxiety disorder) through ocular biomarkers. This collaboration, according to the company, could provide new diagnostic modules for Topcon’s Harmony platform.
- Neurolens rebranded to Newton. The company has developed a headset based on Contoured Prism technology, addressing binocularity and its impact on the trigeminal nerve, to provide relief for headaches, motion sickness, and neck pain, for example.
ASCRS news and events
- Business of Refractive Cataract Surgery (BRiCS) 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 Cincinnati on September 25.
- 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 18. Submit an abstract and get involved in the 2026 ASCRS Annual Meeting.
Research highlights
- The accuracy of two corneal refractive power measurements for IOL power calculations in post-myopic LASIK eyes was investigated in a study published in the journal Eye. Corneal refractive power centered on the corneal (Kapex) and pupil center (Kpupil), decentration of ablation zone, and Kappa angle were measured with Pentacam (Oculus). Ninety-two eyes were included in the analysis. Mean error, mean absolute error, and median absolute error were lower with Kapex. Mean error was also lower with Kapex when there was a larger decentration of ablation zone and a larger Kappa angle. Average Kapex was higher than average Kpupil, according to the authors. Prediction error with Kpupil was associated with decentration of the ablation zone, but this association was not found with Kapex. The authors concluded that Kapexresulted in better IOL power calculation accuracy in these eyes, especially those with a large decentration of ablation zone or large Kappa angle.
- A retrospective comparative chart review looked at the impact of two side-cut angle profiles on the outcomes of femtosecond LASIK. The review compared eyes with a 70-degree side-cut angle to those with a 120-degree angle (monovision cases and cases with intraoperative complications were excluded). Analysis of 318 matched eyes showed that postoperative striae occurred more often in the eyes with a 120-degree angle cut (3.1%) compared to the 70-degree cut (0.9%). There were no significant differences in either group when it came to epithelial ingrowth, diffuse lamellar keratitis, postop flap refloat and irrigate procedures, halo, or glare, according to the authors. There was a statistically significant higher percentage of eyes in the 70-degree group that were within 0.5 D of target and within 1 D of target. The study was published in the Journal of Cataract & Refractive Surgery.
Product news
- Alcon launched wavelight plus in the U.S. and Canada as “the first fully personalized laser vision correction of its kind, leveraging innovative ray tracing technology.” The company’s press release states that the procedure is based on a 3D model of the eye, created with ocular wavefront, biometry, and corneal tomography measurements, and refractive correction is done without nomogram inputs.
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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