• A surgical team from NYU Langone Health performed the world’s first whole-eye and partial-face transplant. The patient was a 46-year-old military veteran from Arkansas who survived a work-related high-voltage electrical accident. The surgery (which lasted approximately 21 hours and included a team of more than 140 surgeons, nurses and other health-care professionals) included transplanting the entire left eye and a portion of the face from a single donor, making the only successful combined transplant case of its kind. While it is still unknown whether he will regain sight since the procedure, the transplanted left eye has shown signs of health, including direct blood flow to the retina. Read the full article from NYU Langone Health here. 

• Bausch + Lomb announced the American Medical Association (AMA) confirmed assignment of the Category 1 Current Procedural Terminology (CPT) code for XIPERE, the first therapy available in the United States that utilizes the suprachoroidal space to treat patients suffering from macular edema associated with uveitis. 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 will be effective on Jan. 1, 2024. The XIPERE J-code J3299 became effective in July 2022.

• Bausch + Lomb announced Cornea published results from the KALAHARI Phase 3 extension trial, which assessed the long-term safety and efficacy of MIEBO in 208 patients who were 18 years of age and older, had signs and symptoms of dry eye disease associated with meibomian gland dysfunction, and completed the randomized, double-masked, hypotonic saline-controlled Phase 3 trial (GOBI). During the trial, participants administered one drop of MIEBO four times daily in both eyes for 52 weeks. The KALAHARI study showed sustained efficacy over the entire 52-week study. In addition, MIEBO maintained improvements in total corneal fluorescein staining (tCFS) and visual analog scale (VAS) eye dryness observed in GOBI. Patients treated with saline in GOBI who switched to MIEBO treatment in KALAHARI showed improvements in tCFS and VAS scores by week 4.

• OnPoint Vision announced the FDA approval of its Investigational Device Exemption (IDE) application to begin Phase 1 of its pivotal clinical trial of the AccuraSee Intraocular Pseudophakic Capsular Lens (IOPCL) Magnifier (MAG) for secondary implantation in the capsular bag with a pre-existing 6 mm acrylic posterior chamber IOL. The IOPCL MAG is neutral optic (plano power) with a central +10.0 D 1.8 mm zone designed to magnify near images when unilaterally implanted in low-vision pseudophakic subjects with stable AMD at least 6 months after cataract surgery. In addition, the company announced the FDA approval of a third refractive Early Feasibility Study IDE to evaluate the initial safety and effectiveness of the AccuraSee IOPCL (monofocal) for secondary implantation in the capsular bag to improve near and/or intermediate vision by inducing myopia (monovision) when implanted in the non-dominant eye at least 6 months after previous cataract surgery. 

• The FDA granted Regenerative Medicine Advanced Therapy (RMAT) 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). RMAT designation was granted based on positive 6-month efficacy data from the company’s ongoing Phase 1/2 clinical trial of ATSN-101, which demonstrated clinically meaningful improvements in vision at the highest dose with no drug-related serious adverse events 6 months post-treatment. Atsena also received orphan drug designation from the FDA for ATSN-101 for the treatment of LCA1.

• 20/20NOW and Visionix USA announced a strategic alliance to bring tele-optometry to more physicians and optical retailers in North America. 20/20NOW will utilize the new VX650 multi-testing platform from Visionix that performs automated pretesting in one device, including auto-refraction, non-contact tonometry, corneal topography, pachymetry as well as anterior and poster segment imaging in one sitting without having to readjust positions. This reduces equipment footprint and allows pretesting to be completed in 5-7 minutes, saving on average 10 minutes per exam. This alliance will also enable 20/20NOW to deliver comprehensive eye exams in under 20 minutes from start to finish.

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.