Topline Phase 3 pivotal study for BRIMOCHOL for treatment of presbyopia

Tenpoint Therapeutics announced positive topline results from its Phase 3 pivotal trial evaluating BRIMOCHOL PF (carbachol/brimonidine tartrate fixed-dose combination) for temporary treatment of presbyopia. According to the company’s press release, primary visual acuity endpoints were met with statistically significant improvements in near vision compared to vehicle, and it was well-tolerated with no serious treatment-related adverse events. The company described the study as the “largest and longest safety study ever conducted in the presbyopia eye drop category,” with 12 months of daily dosing. The 3-arm, multicenter, randomized, double-masked, safety and efficacy study compared BRIMOCHOL PF to carbachol monotherapy and vehicle in emmetropic phakic and pseudophakic patients with presbyopia. The study enrolled 629 patients at 47 sites in the U.S. Tenpoint Therapeutics, which merged with Visus Therapeutics in 2024, plans to file in the U.S. in the first half of 2025.

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Positive Phase 2b/3 results for oral treatment of thyroid eye disease

Sling Therapeutics announced positive topline efficacy and safety data from the Phase 2b/3 trial evaluating its oral small molecule treatment for thyroid eye disease (TED), linsitinib. This drug, according to the company’s press release, is taken twice daily to inhibit IGF-1R, the only validated clinical target for TED. IGF-1R is associated with inflammation and proptosis in TED. Linsitinib has an established safety profile from 15 other clinical trials in other disease areas. In the Phase 2b/3 multicenter international study, 90 patients were randomized 1:1:1 to receive 150 mg or 75 mg linsitinib or placebo twice daily for 25 weeks. According to the company, the study met its primary endpoint with statistical significance in the 150 mg dose group. From a safety standpoint, the drug was well tolerated in areas the company was interested in; it did not have drug-related hearing impairment or menstrual cycle changes and experienced a low (3%) hyperglycemia rate. The company reported that most adverse events were mild/moderate, reversible, and resolved with discontinuation or a pause in the investigational therapy. The company plans to move on to a Phase 3 confirmatory trial this year.

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Clinical plan for first-in-human trial for investigational dry AMD therapy

PulseSight Therapeutics submitted a Clinical Trial Authorization plan in France to begin a Phase 1, first-in-human trial for PST-611 as an investigational therapy for dry AMD. This trial would be a single ascending dose trial to confirm the safety profile of the drug and establish a maximum dose for a Phase 2 proof-of-concept study, according to the company’s press release, enrolling 6–12 patients with dry AMD. The company expects to begin the study in the second quarter of this year with a readout by the end of 2025 or early 2026. According to the company’s press release, PST-611 is a first-in-class, non-viral vectorized therapy that expresses human transferrin, an iron regulator to restore normal iron homeostasis. Previous research has demonstrated a “favorable safety profile of its electrotransfection delivery system and plasmid technology, as well as preclinical experiments demonstrating the beneficial effects of PST-611 in reducing oxidative stress and inflammation, and preserving the integrity of the retinal pigment epithelium, with the potential of preventing retinal degeneration and vision loss,” according to the company.

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Update on registrational program therapy targeting various retinal diseases

Ocular Therapeutix provided an update on its registrational program for AXPAXLI, axitinib intravitreal injection (OTX-TKI). According to the company’s press release, the first registration trial for APAXLI for wet AMD has completed randomization, and topline data is expected in the fourth quarter of 2025. The company plans to seek FDA feedback this year on its clinical trial design for AXPAXLI for treatment of non-proliferative diabetic retinopathy. AXPAXLI is a bioresorbable hydrogel that incorporates axitinib, a “small molecule, multi-target, tyrosine kinase inhibitor with anti-angiogenic properties.”

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Collaboration to develop RNAi program targeting geographic atrophy

City Therapeutics and Bausch + Lomb announced their collaboration to develop RNA interference (RNAi)-based medicine as a novel therapy for the treatment of retinal diseases, including geographic atrophy. Separately, Character Biosciences and Bausch + Lomb announced their collaboration to develop a “patient data platform and AI-powered analytical engine to drive novel drug discovery and development” focused on AMD.

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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. Find the Preview Program here.
• Online education: There are a few recently posted online education opportunities from ASCRS: 1) ASCRS Ground Rounds, 2) a webinar focusing on OCT from the Retina Clinical Committee, 3) ASCRS Live! Roundtable, and 4) a YES Connect webinar.
• 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

• The secondary analysis of efficacy and safety of different atropine regimens for treatment of myopia over a 3-year period was published in JAMA Ophthalmology. This study took place in Dublin, Ireland, including children and teenagers who were randomly assigned to receive placebo nightly for 2 years followed by 0.05% atropine for 1 year (group 1) or 0.01% atropine nightly for 2 years and who were then rerandomized to receive placebo nightly, tapering placebo, or tapering 0.01% atropine drops for 1 year (group 2). The main outcomes were observed changes in cycloplegic spherical equivalent refraction and axial length from month 24, which served as the baseline, to month 36. According to the authors, “compared with the group taking placebo then 0.05% atropine, the combined atropine then placebo groups had more spherical equivalent progression (adjusted difference, −0.13 diopters [D]; 95% CI, −0.22 to −0.04 D; P=.01) and axial elongation (adjusted difference, 0.06 mm; 95% CI, 0.02-0.09 mm; P=.008), and the group taking 0.01% atropine then tapering 0.01% atropine had more axial elongation (adjusted difference, 0.04 mm; 95% CI, 0.009–0.07 mm; P=.04).” Group 1 experienced more cases of blurred near vision and photophobia. The authors concluded that while there were more adverse events in group 1, there were no differences in treatment completion rates, and due to a decrease in myopia progression and axial length elongation in this group, compared to those using placebo, this supports “consideration of treatment as given to the group taking 0.05% atropine in this European population.”
• The visual and refractive outcomes and postop axis alignment of toric ICLs after use of manual or digital marking techniques for implantation were compared in a prospective, randomized, single-centered intraindividual comparison published in the Journal of Cataract & Refractive Surgery. The study included patients who were having bilateral toric ICL implantation for treatment of myopia with astigmatism of 0.5 D or more. According to the paper, patients received both marking techniques. The gain in CDVA was comparable between the two marking techniques, as was safety and efficacy indices. Postop axial misalignment was 2.8±3.1 degrees in the digital group and 4.4±5.1 degrees in the manual group. There were no significant differences between manual and digital marking, but the authors noted that “digital marking [offered] a potential advantage in efficacy.”

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Product news

• The FDA approved Zeiss Medical Technology’s MEL 90 excimer laser. Approval included its use for treatment of myopia, hyperopia, and mixed astigmatism. According to the company’s press release, the MEL 90 laser integrates into Zeiss’ Corneal Refractive Workflow.
• The FDA cleared the Epithelial Thickness Module available on Heidelberg Engineering’s ANTERION Cornea App.
• The ECHO Green Pattern Laser photocoagulator (Norlase) received Health Canada licensing.
• Bausch + Lomb began its commercial launch of the enVista Apsire monofocal and toric IOLs in the European Union, after receiving the CE mark late last year. This lens has been available in the U.S. since 2023.

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