Topline results from trial for biologic eye drop for dry eye

Oculis announced topline results from its Phase 2b trial evaluating licaminlimab for treatment of dry eye disease. According to the company’s press release, licaminlimab is a novel anti-TNFɑ biologic eye drop that has both anti-inflammatory and anti-necrotic mechanisms of action. The trial, which included 122 patients randomized to either licaminlimab or vehicle at four study sites with 6 weeks of treatment and 2 weeks of follow-up, resulted in more improvements of sign endpoints in the study group in the areas of fluorescein staining and Schirmer’s testing. In analysis of a subpopulation of the study group that included patients who had a TNFR1-related genotype (n=23), a rapid treatment effect was observed as early as day 15 and was, according to the company, statistically significant at the final efficacy visit on day 43. The drug was well tolerated. The company stated that it will finalize Phase 3 development plans after an end-of-Phase 2 meeting with the FDA.

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First patient dosed in Phase 3 trial evaluating oral non-opioid sedation

Melt Pharmaceuticals announced the dosing of the first patient in its Phase 3 program that is evaluating safety and efficacy of MELT-300, an oral tablet that combines midazolam (3 mg) and ketamine (50 mg). According to the company’s press release, the study evaluating this non-IV, non-opioid drug will compare in a 4:1:1 ratio MELT-300 to sublingual midazolam and sublingual placebo in 528 patients at 14 trial sites. Topline results are expected in the fourth quarter of 2024.

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First patient dosed in retinitis pigmentosa gene therapy trial

Beacon Therapeutics announced that it dosed its first patient in a gene therapy trial for patients with X-linked retinitis pigmentosa. The study will evaluate two dose levels of AGTC-501 compared to an untreated control group. The data from this trial and prior trials, according to the company, will be used to support a biologic license application in the U.S. and Europe. AGTC-501 already has the Fast Track Designation from the FDA and other designations outside the U.S. AGTC-501 is a gene therapy expressing the full length of the RGPR protein, which the company said addresses “the full complement of photoreceptor damage caused by XLRP.”

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Clinical program for IOP-lowering drug discontinued

Skye Bioscience announced that it would be discontinuing its development of SBI-100 ophthalmic emulsion after its Phase 2a clinical trial did not meet its primary endpoint. According to the company, SBI-100 is part of a novel class of drugs that the company was investigating to modulate the endocannabinoid system for patients with primary open-angle glaucoma or ocular hypertension. The company stated that it was now directing all of its clinical development resources to its metabolic program.

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ASCRS news and events

• ASCRS Business of Refractive Cataract Surgery Summit: ASCRS is introducing a new course that will help practices gain the navigational tools needed to increase advanced-technology IOL adoption and lead patients on their refractive surgery journey. Learn more.
• ASCRS Live! The next stop for the ASCRS Live! dinner series, which is bringing education and networking events to several U.S. cities in 2024, is Washington, D.C., July 18. Register now.
• 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.
• ASCRS Annual Meeting: Hotel blocks are open for the 2025 ASCRS Annual Meeting in Los Angeles, California, April 25–28, 2025.

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Research highlights

• The effect of anterior capsule polishing on postop capsule opacification and capsular bend was evaluated in a prospective, self-controlled trial published in the Journal of Cataract & Refractive Surgery. The study included 21 patients (42 eyes) with normal axial length having cataract surgery who were assigned in one eye to receive intraoperative anterior capsule polishing and in the contralateral eye no polishing. Capsular bend index, anterior capsule opacification, posterior capsule opacification, and anterior capsule opening were recorded at week 1 and 1, 3, 6, and 12 months postop. The authors found significant differences in capsular bend index within the two groups between week 1 and 1 month and between 6 and 12 months postop. Between the two groups, the authors noted a significant difference in capsular bend index at 1 week postop. There were no significant differences between the groups in anterior capsule opacification or posterior capsule opacification. The authors concluded that “360 degrees anterior capsule polishing can delay early capsular bag deformation without increasing the risks of ACO and PCO. This approach can also limit contraction of the anterior capsule opening.”
• A retrospective chart review compared the visual outcomes of topography-guided or wavefront-optimized LASIK. According to the paper published in Clinical Ophthalmology, the Contoura Phorcides treatment was applied to 227 eyes and the wavefront-optimized treatment to 121 eyes, both using the Wavelight EX500 laser (Alcon).There was a significantly higher percentage of eyes in the Contoura Phorcides group that achieved 20/16 or better vision than the wavefront-optimized group, 57% vs. 17% respectively. The percentage of eyes that gained 1 or more Snellen lines of UDVA compared to preop CDVA, according to the authors, was also significantly higher in the Contoura Phorcides group (47%) compared to the wavefront group (12%).

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Product news

• Nidek received the CE mark for its NP-1/NP-1C Preloaded IOL Injection System.

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