• Nova Eye Medical has been granted FDA 510(k) clearance for its new canaloplasty device, iTrack Advance. The iTrack Advance has been cleared for microcatheterization and viscodilation to reduce IOP in adult patients with primary open-angle glaucoma. The iTrack Advance leverages the same proprietary features of the company’s original iTrack, including a 200-micron illuminated canaloplasty microcatheter, but has been designed for improved surgical efficiency. A key feature of the iTrack Advance is an ergonomic handpiece. In the United States, the iTrack Advance has been cleared for canaloplasty both with and without concurrent cataract surgery. The iTrack Advance will be officially launched in the United States at the 2023 ASCRS annual meeting.

• Bausch + Lomb and Heidelberg Engineering announced the introduction of the SeeLuma Fully Digital Surgical Visualization Platform, which provides ophthalmic surgeons with a new level of visualization compared to optical, hybrid and retrofitted microscopes. Developed to facilitate even the most complex surgical procedures, SeeLuma features a heads-up 3D monitor that facilitates 3D heads-up surgery using next-generation 3D 55” and 31” 4K monitors, multiple digital display options and an intuitive interface for sharp visualization, ergonomics, smooth workflow and an immersive educational experience. SeeLuma will be introduced in the United States this month.

• Eversight announced the availability of Descemet’s membrane endothelial keratoplasty (DMEK) tissue preloaded in EndoGlide. Preloaded DMEK EndoGlide utilizes an endothelium-in or trifold loading method. Using an anterior chamber maintainer for infusion, the graft is pulled into the eye with specialized forceps through a 2.65 mm incision. The pull-through technique and endothelium-in attribute of preloaded DMEK EndoGlide provide added control of the graft and its orientation, which is critical to the success of the procedure and may make DMEK more achievable in complex eyes.

• Radius XR launched its Radius 1.0 software release for perimetric examinations. The company says its interface is designed to assist eye-care practices in delivering more comprehensive glaucoma management. The portable vision diagnostic and patient engagement system combines medical-grade diagnostics, business management and patient education tools in a single wearable device. Radius 1.0 features the Radius Adaptive Testing Algorithm (RATA) for clinically accurate results. The multi-modal platform can perform a growing range of vision tests, including visual field (24-2 RATA Standard, 24-2 RATA Fast, 10-2 Standard, 30-2 Standard, Radius RAPID, ptosis screening, Estermann), visual acuity, Amsler grid, contrast sensitivity, color vision, ocular motility, pupillary response and confrontation fields.

• Horizon Therapeutics announced that the FDA has approved an update to the Indications and Usage section of the Tepezza label to specify its use for the treatment of “Thyroid Eye Disease regardless of Thyroid Eye Disease activity or duration.” The label update follows positive topline results from its randomized, double-masked, placebo-controlled Phase 4 clinical trial evaluating Tepezza (teprotumumab-trbw) for the treatment of adults with chronic thyroid eye disease (TED) and low Clinical Activity Score. At Week 24, patients treated with Tepezza achieved a 2.41-mm reduction in proptosis from baseline compared with 0.92 mm for those receiving placebo; and 62% of patients treated with Tepezza had a clinically meaningful improvement in proptosis at Week 24 (≥ 2 mm) compared with 25% of patients receiving placebo. The study evaluated patients with an initial diagnosis of TED between 2 to 10 years before the study and with low disease activity levels (chronic TED). 

• The FDA granted Fast Track designation for Kala Pharmaceuticals’ human mesenchymal stem cell secretome (MSC-S) therapy (KPI-012) for the treatment of persistent corneal epithelial defect (PCED). In February 2023, Kala dosed the first patient in its CHASE Phase 2b trial evaluating KPI-012 for the treatment of PCED. In March 2023, Kala announced positive safety data from the first cohort of two patients who were treated with a high dose of KPI-012 (3 U/mL) q.i.d. Both patients successfully completed at least 1 week of dosing with no safety issues observed. The trial has now advanced to Cohort 2, which will evaluate the safety and tolerability of two doses of KPI-012 in ophthalmic solution (3 U/mL and 1 U/mL) vs vehicle dosed topically QID for 56 days in approximately 90 patients. The primary endpoint of the trial is the complete healing of the PCED as measured by corneal fluorescein staining.

• Allegro Ophthalmics announced it received agreement from the FDA under a Special Protocol Assessment for the design of its Phase 2b/3 clinical trial of risuteganib (Luminate) for the treatment of intermediate, non-exudative AMD (dry AMD). Finalization of this assessment indicates that the FDA agrees that critical elements of the overall protocol design (eg, entry criteria, dose selection, endpoints, and planned analyses) are adequate and acceptable for a study intended to support a future marketing application. The Phase 2b/3a study will evaluate efficacy at 52 weeks and safety through 96 weeks. The primary endpoint of the study is the improvement in BCVA at 52 weeks in the active risuteganib group vs the sham control group. 

• The FDA cleared the investigational new drug application for Aviceda Therapeutics’ AVD-104, enabling the company to proceed with initiating Phase 2 clinical trials of its lead intravitreal ocular asset for the treatment of geographic atrophy (GA) secondary to AMD. AVD-104 is an intravitreal nanoparticle molecule with a dual mechanism of action for the treatment of GA. This is accomplished through its modulation of critical inflammatory pathways via inhibition of the activity of retinal macrophages and repolarization of activated macrophages to their resolution state coupled with inhibition of complement cascade amplification. The Phase 2 SIGLEC trial is expected to begin in Q2 2023. 

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.