WHAT’S NEW IN GLAUCOMA

AbbVie and iSTAR Medical SA announced a strategic transaction to further develop and commercialize iSTAR’s MINIject device, a minimally invasive glaucoma surgical device for patients with glaucoma. This complementary alliance will support iSTAR’s development and commercial efforts for MINIject, as well as provide an opportunity to expand AbbVie’s eye-care business.

Glaukos Corp. received 510(k) clearance from the FDA for the iStent infinite Trabecular Micro-Bypass System indicated for use in a standalone procedure to reduce elevated IOP in patients with primary open-angle glaucoma (POAG) uncontrolled by prior medical and surgical therapy. The iStent infinite includes three heparin-coated titanium stents preloaded into an auto-injection system.

Icare USA announced 510(k) clearance from the FDA for its next generation iCare HOME2 self-tonometer (See page 24). The device measures patients’ real-world IOP outside normal clinic hours to help support glaucoma management. iCare CLINIC cloud-based software stores IOP data measured by the iCare HOME2 and provides reports to health-care professionals with an in-depth overview of changes in patients’ IOP.

Iridex Corp. introduced its Sweep Management Software for MicroPulse Transcleral Laser Therapy, which is now integrated into the Cyclo G6 Glaucoma Laser System and supports the sweep duration methodology shared by the International MicroPulse TLT Delphi Panel.

Lumibird Medical launched the next generation YAG/SLT laser, the Tango Reflex Neo, by Ellex. A fully integrated Q-switched Nd:YAG and frequency doubled Nd:YAG laser for anterior-segment YAG and glaucoma indications, Tango Reflex Neo features second-generation Reflex technology with True Coaxial Illumination, enhancing visualization of anterior and posterior segments.

Nicox SA announced that once-daily dosing of NCX 470 0.1% met the primary objective of non-inferiority in lowering IOP in the Mont Blanc Phase 3 clinical trial in patients with POAG or ocular hypertension (OHT). The IOP-lowering effect from baseline for NCX 470 was 8.0 to 9.7 mm Hg. In a pre-specified secondary efficacy analysis of time-matched change from baseline IOP, the IOP reductions were numerically greater at all six timepoints and statistically significant (p<0.049) at four of the six timepoints.

Santen Inc. and UBE Corp. announced the FDA approved OMLONTI (omidenepag isopropyl ophthalmic solution) 0.002% eyedrops for the reduction of elevated IOP in patients with POAG or OHT. Omidenepag isopropyl, the active pharmaceutical ingredient in OMLONTI, increases aqueous humor drainage through the conventional (or trabecular) and uveoscleral outflow pathways.

Thea Pharma announced the FDA approval for the new drug application of IYUZEH (latanoprost ophthalmic solution) 0.005%, the first clinically proven formulation of latanoprost available in the United States that is preservative-free, for the reduction of elevated IOP in patients with POAG or OHT.

IN THE NEWS:

Bausch + Lomb and AcuFocus Inc. announced an affiliate of Bausch + Lomb acquired AcuFocus. Bausch + Lomb also introduced PreserVision AREDS 2 Formula mini soft gels with a new OCUSorb formula. Additionally, Bausch + Lomb and Modulight Corp. announced the FDA approved the ML6710i photodynamic laser for equivalent use with Bausch + Lomb’s VISUDYNE photodynamic therapy for the treatment of patients with predominantly classic subfoveal choroidal neovascularization, or the creation of abnormal choroidal blood vessels, due to AMD.

With the new GONIO ready from OCULUS, when performing MIGS, surgeons can attach the gonio lens to the microscope rather than having to hold the gonio lens with one hand. The gonio lens is attached to the microscope via an adapter with a flexible “swan neck,” referred to as the Flex System. This avoids any additional pressure against the patient’s eye.

FCI Ophthalmics announced the US availability of EZYPOR, a high-density polyethylene orbital implant for enucleation, evisceration and secondary implantation. The implant comes with a smooth anterior suturing platform with eight suture tunnels, allowing for multiple suturing options. EZYPOR has a porosity between 40% and 60% for optimum colonization of fibrovascular tissues.

Focus Vitamins launched new Focus PI (post-injection) eyedrops that are formulated to provide relief from irritation and dryness from eye injections. Focus PI eyedrops are extra viscous with 0.7% hypromellose and offer enhanced lubrication that helps alleviate discomfort in the eyes after injections, including anti-VEGF injections to treat AMD.