Topline Phase 3 results for sublingual, opioid-free sedation

Melt Pharmaceuticals announced positive topline results from its Phase 3 pivotal study evaluating safety and efficacy of MELT-300, a sublingual, non-opioid sedation method for cataract surgery. According to the company’s press release, the midazolam (3 mg) and ketamine (50 mg) fixed combination administered using Zydis drug delivery (Catalent) can dissolve in as little as 3 seconds. The Phase 3 data, according to the press release, will support regulatory submission.

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Phase 1 results for non-surgical cell therapy for corneal edema

Emmecell announced topline results for its Phase 1 extension study evaluating EO2002 as a non-surgical cell therapy for treatment of corneal edema. The randomized, double-masked trial showed significant improvement in BCVA and central corneal thickness among all cohorts, and there were no ocular or treatment-related serious adverse events. The cohort that received 150,000 cells achieved an 11-letter mean change in BCVA at 6 months, and 38% of the participants in this group had an at least 15-letter gain.

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First Phase 2 study evaluates wet AMD gene therapy in both eyes of patients

Regenxbio announced the results of a Phase 2 fellow eye sub-study evaluating the subretinal delivery of ABBV-RGX-314, a one-time gene therapy, for treatment of bilateral wet AMD. The data showed a 97% treatment burden reduction at 9 months after the gene therapy with a favorable safety and efficacy profile consistent with that in previous studies. According to the company’s press release, this gene therapy program has the longest-term data for wet AMD.

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Update on Phase 3 study evaluating treatment for progressive myopia

Eyenovia reported that an independent data review committee evaluated data from the company’s Phase 3 trial for low-dose atropine dispensed using the proprietary Optejet platform for treatment of progressive myopia. The review found that there was not a significant difference between the two treatment arms (0.01% and 0.1% atropine ophthalmic metered spray) and placebo among the 252 participants included. The trial did not meet its primary endpoint of a less than 0.5 D progression in visual acuity over 3 years.

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FDA to review NDA for first-in-class dry eye treatment

Aldeyra Therapeutics announced that the FDA accepted the company’s resubmitted NDA for topical reproxalap for review. This first-in-class new drug candidate for dry eye treatment has a PDUFA date set for April 2, 2025. In its press release, Aldeyra also noted the option agreement it entered into with AbbVie to develop, manufacture, and commercialize reproxalap in the U.S.

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Enrollment complete for Phase 1/2 study evaluating novel IOP-lowering drug delivery platform

SpyGlass Pharma announced that it completed enrollment for its Phase 1/2 randomized, multicenter, controlled trial evaluating the SpyGlass Drug Delivery platform for patients with glaucoma or ocular hypertension. According to the company, a bimatoprost-loaded implant is mounted onto an IOL that is delivered during cataract surgery. The implant is designed to deliver IOP-lowering medication for 3 years.

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ASCRS news and events

• 2025 ASCRS Annual Meeting: Registration is open for the ASCRS Annual Meeting, taking place April 25–28, in Los Angeles, California.
• ASCRS Live!: This educational dinner series has made its way to several cities across the U.S. this year. Registration is open for the final event of 2024 in Denver, Colorado, on December 5. Stay tuned for information about 2025 in-person events.
• ASCRS 50th anniversary: ASCRS members from the 50 states are sending in their perspectives on the Society, its impact on their career, and its influence on the specialty as a whole. Stay tuned each week through April 2025 for a new video.

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Research highlights

• A prospective time and motion study was conducted at two high-volume cataract surgery clinics in India to determine the time and resource savings that could occur with integration of a digital cataract workflow. According to the paper, published in the Journal of Cataract & Refractive Surgery, the time to complete preoperative measurements, surgical planning, and surgical procedures as well as the number of data fields and the support staff required both pre- and post-digital workflow integration were recorded. The study included 85 cataract workflows, finding that the integration of the digital workflow into the sites’ existing EMR workflow reduced the mean time for preop measurements by 25.3%, surgical planning by 55.1%, and surgical procedures by 22.6%. The number of data fields recorded and support staff needed were significantly lower after digital workflow was added to the system.
• A systematic review and network meta-analysis published in the journal Eye focused on monovision and bilateral multifocal IOL implantation for treatment of presbyopia at the time of cataract surgery. According to the paper, 32 studies were included in the meta-analysis, and the authors found “monovision to be inferior to [bilateral multifocal IOL implantation].” The authors noted that the multifocal IOLs were “more likely to provide complete spectacle independence.” However, monovision resulted in less glare. There was also no statistically significant difference between the two groups for unadjusted distance visual acuity or unadjusted near visual acuity.

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