Primary, secondary endpoints met in Phase 2 wet AMD trial

EyePoint Pharmaceuticals announced positive topline data from its Phase 2 trial of EYP-1901, which met all of its primary and secondary endpoints. According to the company’s news release, both cohorts that received EYP-1901 demonstrated a statistically non-inferior change in BCVA compared to those in the aflibercept (control) group. There were no serious adverse ocular or systemic events with EYP-1901. In addition, there was a more than 80% reduction in treatment burden, and more than two-thirds of eyes were supplement-free for up to 6 months post-treatment (more than 80% were supplement-free or had one supplement). The patient discontinuation rate up to week 32 was 4%. The company stated that this data supports its Phase 3 non-inferiority design. EyePoint is preparing to begin its first pivotal trial for EYP-1901 for wet AMD in the second half of 2024.

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Modifications made to investigational glaucoma treatment device

Ciliatech released a new design of its Cilioscleral Interpositioning Device (CID), which the company described as a new class of implant to treat glaucoma. According to the company, this is being designed to use a cilioscleral technique to lower IOP, while preserving the anterior chamber of the eye and sparing endothelial cells and avoiding filtration blebs. The company’s press release stated that its modifications are in the shape and geometry of the device to improve safety and performance. Ciliatech plans to pursue the CE Mark and FDA approval with the hope of bringing CID to market in 2025.

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Positive Phase 1/2 data from clinical trial for treatment of Leber congenital amaurosis

Atsena Therapeutics announced positive 12-month safety and efficacy data from its Phase 1/2 clinical trial of ATSN-101 for treatment of GUCY2D-associated Leber congenital amaurosis. According to the company’s press release, the Phase 1/2 study included 15 patients 12–76 years old who received unilateral subretinal injections of the gene therapy, with three adult cohorts (three participants in each cohort) being treated with three ascending doses and one adult and one pediatric cohort (three participants in each) being treated with a high dose. According to the company, ATSN-101 resulted in “clinically meaningful improvements in vision at the highest doses with no serious treatment-emergent adverse events.” ATSN-101 has been granted an Orphan Drug Designation and a Regenerative Medicine Advanced Therapy designation by the FDA.

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Results from first-in-human study of siRNA treatment for AMD

OliX Pharmaceuticals announced positive results from its Phase 1 study of OLX10212 for treatment of AMD. OLX10212 is a small interfering RNA (siRNA), targeting a pathway that is “believed to play a critical role in the development of AMD.” This is considered a novel treatment approach. The study was multicenter, single dose, and dose escalating, evaluating safety and efficacy of the therapy in patients with neovascular AMD. According to the company’s press release, there were no adverse events related to the OLX10212 injections (specifically no signs of inflammation or changes in intraocular homeostasis); there were no systemic effects. This study, according to the company, helped identify dose levels for future trials. There was a preliminary improvement in BCVA among treated participants.

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Possibility of a minimally invasive approach for treating AMD

A team of researchers at the University of Hong Kong have developed a “light-activatable prodrug nanomedicine” for treatment of AMD. According to a press release from the university, the nanomedicine is delivered via intravenous injection and light is applied to the eye, creating an anti-angiogenic and photodynamic combination therapy. According to the university, this study “represents the first attempt at integrating a photoactivatable, anti-angiogenic agent with a photosensitiser into a single nanoformulation for AMD treatment.” Further, the university press release stated that the formulation uses FDA-approved therapeutic agents.

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ASCRS news and events

• ASCRS Annual Meeting: Registration for the 2024 ASCRS Subspecialty Day and ASCRS Annual Meeting is now open. Learn more about this premier educational and networking event for anterior segment surgery here.
• A Taste of ASCRS: This nine-section CME program is available on demand. Learn more about the program.

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Research highlights

• The long-term impact of atropine treatment (0.01% to 1.0%) for treatment of pediatric myopia was investigated in a prospective, double-masked, observational study published in JAMA Ophthalmology. The Atropine for the Treatment of Myopia (ATOM1) and ATOM2 randomized clinical trials included adults who were reviewed from 2021–2022 after taking atropine 1% vs. placebo from 1999–2003 and atropine 0.01% vs. 0.1% vs. 0.5% from 2006–2012, respectively. The study found that for about one-quarter of participants, use of atropine was “not associated with differences in final refractive errors 10 to 20 years after treatment.” The authors reported no increased incidence of treatment-related or myopia-related ocular complications in the 1% atropine group vs. placebo. The authors stated that these findings could impact future clinical trial design and advocated for more studies to investigate duration and concentration of atropine for pediatric myopia control. Invited commentary about the long-term results called them “candidly … disappointing.” “The ATLAS [Atropine Treatment Long-Term Assessment Study] results remind us that there is uncertainty regarding the long-term value and safety of atropine eye drops for myopia control. These findings highlight the need for randomized clinical studies to define effective and safe myopia control strategies early in myopia development but also include methods to obtain the critical long-term studies of refractive error outcomes,” Michael Repka, MD, wrote in JAMA Ophthalmology.
• The 1-year effects of intrastromal corneal ring segments on dynamic corneal response for patients with keratoconus was evaluated in a study published in the Journal of Cataract & Refractive Surgery. The prospective, single-center, clinical study included 30 eyes of patients with at least 12 months of follow-up (mean 15 months). The intracorneal ring segments significantly improved corneal biomechanics measurements from preop measurements, with a significant increase in stress-strain index. The authors confirmed that this difference was induced due to stiffening with further analysis. They concluded that patients with keratoconus who receive intracorneal ring segments can expect “a significantly stiffer response due to increased structural support compared with preoperative values and 1 month postoperative.”

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Product news

• Apple announced a new feature for its iOS 17 that is designed to “help protect your vision.” Screen Distance in Screen Time “encourages you to move your iPhone farther away if you’ve held it closer than 12 inches for an extended period [of time].”

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