• Iridex Corp. announced the full US market launch of the next-generation Iridex PASCAL laser with MicroPulse. The new PASCAL platform combines fast and precise pattern scanning capabilities in a smaller, ergonomically optimized integrated laser platform. The platform includes three tissue-sparing technology options. MicroPulse Mode, Iridex’s proprietary and patented technology, chops a continuous-wave laser beam into sequences of short, repetitive, low-energy pulses separated by longer rest periods. This allows the tissue to cool between laser pulses. Endpoint Management is a pattern subthreshold retinal laser therapy that uses an algorithm to control laser power and pulse duration, optimizing the therapeutic effect. Pattern Scanning Laser Trabeculoplasty provides a rapid, computer-guided treatment that applies a sequence of patterns onto the trabecular meshwork to reduce IOP.

• Visus Therapeutics reported positive topline clinical data from its Phase 3 pivotal BRIO-I trial of BRIMOCHOL PF (carbachol/brimonidine tartrate fixed-dose combination), a preservative-free eyedrop, for the treatment of presbyopia. BRIO-I met the pre-specified primary study endpoints agreed upon with the FDA and EMA/MHRA, demonstrating contribution of elements for the once-daily, carbachol/brimonidine tartrate fixed-dose combination over both active comparators carbachol and brimonidine monotherapies. BRIMOCHOL PF demonstrated statistically significant improvements in near and distance binocular visual acuity at multiple timepoints over carbachol and brimonidine. Clinically and statistically significant reductions in pupil size were also observed out to 10 hours. BRIMOCHOL PF was well-tolerated with no treatment-related serious adverse events.

• NIDEK announced the launch of the NT-1/1e non-contact tonometer models. As an addition to the same series that includes the NT-1p, the NT-1/1e non-contact tonometers were developed without the pachymetry function to address market demand. The NT-1e is a basic model that enables manual measurement with high operability. The NT-1p/1 tonometers perform fully automated measurements and include an air-nozzle contact sensor to ensure patient safety. By placing the chin on the chinrest, the device automatically detects the position of the eyes and measurement begins without any operator assistance facilitated by voice guidance (available in nine languages). The corrected IOP values are displayed by entering the patient’s corneal pachymetry. Also featured on the NT-1 series is a 3D auto tracking function and the continuous range of tilt/swivel of the screen that allows the device to be placed anywhere in an examination room. 

• ViaLase Inc. announced the online publication of 24-month safety data from the first-in-human study of femtosecond laser image-guided high-precision trabeculotomy (FLigHT) performed with the ViaLase technology in Ophthalmology Science. Investigators in this prospective, non-randomized, single center, interventional, single arm trial evaluated 11 patients with open angle glaucoma following FLigHT treatment, which consisted of the creation of a single channel through the trabecular meshwork and into Schlemm's canal. At 24 months post-treatment, the authors reported no device-related serious adverse events and observed well-defined channels with no evidence of closure, indicating medium-term durability. Secondary outcomes included observing IOP at each study timepoint. The data demonstrated a mean IOP reduction of 34.6% from baseline of 22.3 ± 5.5 to 14.5 ± 2.6 mm Hg at 24 months. For more, see the study results here.

• Clearside Biomedical announced plans for ODYSSEY, a randomized, double-masked, parallel-group, active-controlled, multi-center Phase 2b clinical trial of CLS-AX (axitinib injectable suspension) using suprachoroidal delivery in wet AMD. The company plans to open the trial for enrollment at multiple US clinical sites this quarter and expects topline results in Q3 2024. ODYSSEY will enroll treatment-experienced participants with wet AMD and use aflibercept, a current standard of care, as the comparator, over 36 weeks of treatment. Primary outcome measure is mean change in BCVA from baseline to week 36. Secondary outcome measures include other changes in visual function and ocular anatomy, such as central subfield thickness, need for supplemental treatment and treatment burden as measured by total injections over trial duration. The company expects ODYSSEY topline results in Q3 2024. 

• Ocugen Inc. reported positive preliminary data among retinitis pigmentosa (RP) participants treated in the first two cohorts of the Phase 1/2 trial to assess the safety and efficacy of OCU400, a modifier gene therapy product candidate, for RP associated with NR2E3 and rhodopsin mutations and Leber congenital amaurosis with mutation(s) in the CEP290 gene. The study revealed a favorable safety and tolerability profile related to OCU400. Initial clinical data from low- and medium-dose cohorts indicated a positive trend in multi-luminance mobility testing and BCVA scores for OCU400-treated eyes. Additionally, 71.4% of OCU400-treated eyes in low- and medium-dose cohorts experienced at least one lux luminance level improvement in mobility test from baseline; and 66.7% of OCU400-treated eyes in low dose cohorts at 9-month follow-up experienced at least two lux luminance level improvement in mobility test from baseline. 

Quick Notes is published weekly. Unless otherwise noted, the information presented is based on press releases. Find earlier editions here. To submit a press release to be considered for publication, click here.