Positive results in Phase 3 superiority trial for wet AMD treatment

Ocular Therapeutix announced positive results from its Phase 3 superiority trial for AXPAXLI (OTX-TKI) for treatment of wet AMD. According to the company’s press release, after an initial loading phase, the trial compared one dose of AXPAXLI, 0.45 mg, to one dose of aflibercept, 2 mg, in patients with wet AMD. The company reported that at week 36, there was “high statistical significance” demonstrating superiority of AXPAXLI. It also noted that AXPAXLI “showed either statistical significance or numerical superiority to aflibercept, 2 mg, in key secondary and prespecified exploratory endpoints.” About two-thirds of participants were rescue free at week 52.

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Dosing begins for first-in-human myopia prevention drop

The first healthy adult volunteer was dosed in the first-in-human Phase 1 study evaluating IVMED-85 by iVeena Delivery Systems. The randomized controlled trial is evaluating safety and tolerability of IVMED-85, an investigational therapy for prevention of myopia progression. The data from this trial is expected in the third quarter of 2026. According to the company’s press release, the results of this study will inform future clinical studies that will include children with progressive myopia. A Phase 2 study is expected to begin in the second half of 2026.

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Pre-NDA meeting with FDA for IOP-lowering drop

Nicox announced that it received positive written feedback from the FDA regarding its pre-NDA (New Drug Application) meeting, held with the company’s partner Kowa, for NCX 470, a bimatoprost grenod drop for lowering IOP in patients with glaucoma or ocular hypertension. According to the company’s press release, NCX 470 will be submitted as an NDA to the FDA with ownership of the application transferred to Kowa for the submission in the summer of 2026.

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Company news

• Samsung Bioepis signed a settlement and license agreement with Regeneron for the commercialization of OPUVIZ (aflibercept-yszy, Samsung Bioepis), 2 mg, a biosimilar to Eylea (aflibercept, Regeneron), 2 mg. These agreements resolve pending patent issues, according to the company’s press release. The agreement allows Samsung to launch OPUVIZ, which received FDA approval in 2024, in the U.S. beginning in January 2027.
• AMETEK acquired LKC Technologies, the latter of which develops portable devices for diagnosis and monitoring of ocular conditions like diabetic retinopathy.

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ASCRS news and events

• 2026 ASCRS Annual Meeting: Register now for the 2026 ASCRS Annual Meeting in Washington, D.C., April 10–13. View the Preview Program for more information.
• SightLine at ASCRS: Connect, collaborate, and confront the challenges shaping the commercial landscape of ophthalmology at this meeting taking place Thursday, April 9 ahead of the ASCRS Annual Meeting. This meeting is for all commercial stakeholders in ophthalmology to learn about care delivery ideas that will forge a more sustainable financial future. Learn more.
• Business of Interventional Glaucoma: Surgeons and practice administrators alike are invited to the ASOA ASCRS Business of Interventional Glaucoma program, taking place Thursday, April 9 ahead of the ASCRS Annual Meeting and ASOA Annual Meeting. Learn more.

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Research highlights

• Heads-up LASIK with the NGENUITY 3D Visualization System (Alcon) between an experienced surgeon (someone who had performed more than 500 procedures) and a less experienced surgeon (someone who has performed less than 50 procedures) was compared to the procedure with a conventional microscope in a prospective, cross-sectional study published in the Journal of Cataract & Refractive Surgery. The study included 193 eyes from 99 patients. The experienced surgeon performed LASIK using a conventional microscope on 48 eyes and with the 3D microscope on 55 eyes. The less experienced surgeon performed 49 procedures with the conventional microscope and 41 with the 3D microscope. The investigators found the mean operative time for the experienced surgeon to be 1 minute 28 seconds and the less experienced surgeon to be 2 minutes and 3 seconds. The mean operative time was 15 seconds longer for the more experienced surgeon with the 3D microscope, but they authors noted that this additional time was no longer present after the 39th surgery using the 3D system. The younger surgeon did not have a significant difference in operating times between the two microscope systems at any point. There were two cases of intraoperative microerosions (1 for both surgeons) in the 3D microscope group. There were no postop complications in either group. With this the authors concluded that the learning curve with a 3D, heads-up visualization system for an experienced surgeon is short and “young surgeons do not experience increased difficulty.”
• The effect of topical IOP-lowering medications on SLT efficacy and their potential impact on SLT failure were evaluated in a single-center observational cohort study that included 264 SLT procedures (127 patients) in a 10-year period. The authors found that the greater the number of drops before SLT, the higher the risk of failure for SLT. Sixty-two percent of eyes that were not exposed to drops preop saw complete success of their SLT procedure at 1 year, while those who were on a moderate number of drops saw a 36–41% SLT success rate. Patients on what was considered a high number of drops prior to SLT saw a 2% procedural success rate. Other risk factors that were statistically significant included duration of drop therapy, drops with preservatives, glaucoma disease duration, age, previous cataract surgery, having a lower pre-SLT IOP, and use of a lower SLT energy level. This paper is published in the journal Eye.

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Product news

• The EVO/EVO+ ICLs (STAAR Surgical) received an expanded age indication from the FDA. Patients 21 to 60 years old are now eligible for these products. It was previously available for age 21 to 45 years old.
• EYE PCR received the CE Mark for its fixOflex endocapsular device designed to maintain the form of the capsular bag during and after cataract surgery.
• DifGen Pharmaceuticals received FDA approval for its fluorometholone ophthalmic suspension, 0.1%, for ocular inflammation. According to the company, this is the second approval of a generic for this type of suspension.

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