IN THE NEWS
Five Medicare Administrative Contractors (MACs) retired their local coverage determinations (LCDs) for MIGS that were scheduled to take effect on Jan. 29, 2024. The five MACs — WPS Government Health Administrators, Palmetto GBA, Celerian Group Company, National Government Services and Noridian Healthcare Solutions — have issued statements that the final LCDs will not go into effect. The MACs previously published LCDs on MIGS, which identified certain procedures as investigational for glaucoma management in patients over the age of 18. Sight Sciences released a statement supporting the MACs decision, which impacts canaloplasty in combination with trabeculotomy ab interno, a procedural description associated with the company’s OMNI Surgical System. Iridex Corp. says that the company, along with other stakeholders opposing the LCDs, engaged with the MACs throughout the comment period to advocate for continued patient access to these glaucoma treatments. The decision retains reimbursement and full access for Medicare patients to these procedures, including the cyclophotocoagulation procedures performed by Iridex’s G6 laser system and probes.
The FDA approved Glaukos Corp.’s NDA for a single administration per eye of iDose TR (travoprost intracameral implant) 75 mcg, a prostaglandin analog indicated for the reduction of IOP in patients with ocular hypertension or open-angle glaucoma. iDose TR is designed to continuously deliver 24/7 therapeutic levels of a proprietary formulation of travoprost inside the eye.
The FDA granted 510(k) clearance for BELKIN Vision’s Eagle glaucoma laser device, a Q-switched, 532 nm-wavelength, frequency-doubled Nd:YAG laser that is intended for use in performing selective laser trabeculoplasty. The laser energy is delivered in a non-contact procedure directly through the limbus to the trabecular meshwork without the need for the use of a gonioscopy lens.
Ocutrx Technologies introduced the OcuLenz AR/XR headset that is designed to increase visual clarity for individuals living with AMD. The lightweight headset enhances vision by overlaying high-contrast, pixel-manipulated images onto the user’s remaining viable field of view. The system processes real-world video imagery and then recreates it as an augmented reality display tailored to the user’s remaining good vision.
Lumenis launched OptiPLUS, a dual frequency radiofrequency device that delivers heat across different tissue layers. OptiPLUS enables energy penetration to different skin depths, heating the superficial layer to promote collagen formation and stimulate peri-orbital skin rejuvenation while also reaching into the deeper tissue to target the meibomian glands.
Bausch + Lomb announced the American Medical Association (AMA) confirmed assignment of the Category 1 Current Procedural Terminology (CPT) code for XIPERE. The AMA granted the CPT code 67516 with support from the AAO and the American Society of Retina Specialists. The new CPT Category 1 code and their descriptors covering the XIPERE procedure will be included in a future edition of the CPT Codebook and became effective on Jan. 1, 2024.
Compulink Healthcare Solutions announced advancements to its Advantage SMART Practice EHR and practice management solution. Included in this new release are additional AI-enabled features such as the ability for treatment plans to be auto-generated based on diagnosis codes and historic provider-ordering patterns. The release also includes updates to its AI engine, Advantage AI Practice.
The FDA granted Regenerative Medicine Advanced Therapy designation to Atsena Therapeutics’ ATSN-101, the company’s lead investigational gene therapy for patients with Leber congenital amaurosis caused by biallelic mutations in GUCY2D (LCA1). Atsena also received orphan drug designation for ATSN-101 for the treatment of LCA1.
Carl Zeiss Meditec AG entered into an agreement to acquire 100% of the shares in Dutch Ophthalmic Research Center (International) B.V. from the investment firm Eurazeo SE, Paris. ZEISS says the acquisition will enhance and complement its ophthalmic portfolio and range of digitally connected workflow solutions for addressing a wide variety of eye conditions.
Apellis Pharmaceuticals announced data from the GALE extension study following 3 years of continuous treatment with SYFOVRE (pegcetacoplan injection). In Year 3, SYFOVRE reduced GA lesion growth with both monthly (35%; p<0.0001) and every-other-month (EOM) (24%; p<0.0001) treatment compared to the projected sham arm; and reduced nonsubfoveal GA lesion growth with both monthly (42%; p<0.0001) and EOM (28%; p=0.0015) treatment compared to the projected sham arm.
