• Harrow announced the Centers for Medicare & Medicaid Services (CMS) approved transitional pass-through reimbursement status for IHEEZO (chloroprocaine hydrochloride ophthalmic gel) 3%, which is indicated for ocular surface anesthesia. Beginning April 1, 2023, and for the 3 years thereafter, IHEEZO will be eligible for separate reimbursement outside of the surgical bundled payment in both the ASC and hospital outpatient department (HOPD) settings of care. By having pass-through status, IHEEZO will be separately reimbursed by Medicare at average sales price (ASP) +6% in both the ASC and HOPD settings of care. Until an ASP is established, IHEEZO will be reimbursed accordingly at wholesale acquisition cost +3%.

• Cognition Therapeutics announced its investigational new drug application for the investigation of CT1812 for geographic atrophy (GA) secondary to dry AMD has been cleared by the FDA. Cognition plans to initiate the Phase 2 MAGNIFY trial of its oral drug candidate, CT1812, in 2023 in individuals with dry AMD who have measurable GA. The MAGNIFY study is a randomized, placebo-controlled Phase 2 trial expected to enroll approximately 246 people who have been diagnosed with dry AMD with measurable GA. Over the treatment period, change in GA lesion size and BCVA as well as other measures of safety and efficacy will be assessed to determine if treatment can slow vision loss. In addition, CT1812 is being studied in three ongoing Phase 2 clinical trials in Alzheimer's disease and dementia with Lewy bodies.

• Horizon Therapeutics reported the results of an analysis of real-world treatment with TEPEZZA in thyroid eye disease (TED) patients with dysthyroid optic neuropathy (DON). Patients were treated with TEPEZZA between January 2020 and September 2022. After treatment, meaningful improvement was observed in visual acuity in eyes with DON (mean lines of improvement of 3.7 – 23 patients, range 1-15, mean improvement in the mean deviation on visual field testing of -5.87 – seven patients); proptosis (mean reduction of 4.4 mm – 19 patients); diplopia (mean improvement of 0.75 grade – eight patients); and Clinical Activity Score (mean reduction of 5.1 – 17 patients). Horizon also presented new MRI imaging data from the Phase 3 clinical trial showing UPLIZNA reduced the formation of subclinical (asymptomatic) optic nerve lesions in people with NMOSD. The findings showed that a high proportion of participants experienced subclinical optic nerve findings without new symptoms at the end of the randomized controlled period. These were shorter (median length 6 mm) than in those with an optic nerve attack (15 mm, p<0.001) and were not found to be associated with future attacks.

• GenSight Biologics reported topline efficacy and safety results at 3 years post-treatment administration in the REFLECT Phase 3 clinical trial with LUMEVOQ (lenadogene nolparvovec). The results show sustained efficacy and favorable safety for bilateral intravitreal injection of the gene therapy with a statistically significant visual acuity improvement from baseline in both treated eyes, showing an additional benefit of a bilateral injection compared to a unilateral injection. Study results also showed continuous benefits in bilaterally treated patients with +17 to +20 ETDRS letters improvement vs nadir at 3 years, and 62% of bilaterally treated patients off-chart at baseline moved back to on-chart territory at 3 years. For more, see the study results here.

• LumiThera Inc. announced the 24-month data from its LIGHTSITE III, multi-center clinical trial which demonstrated sustained vision improvement in dry AMD subjects treated with the Valeda Light Delivery System. In the PBM-treated arm, there was a statistically significant visual acuity improvement at month 21 following the last treatment with sustained vision benefits throughout the trial including the 24-month trial end. The trial initially demonstrated sustained and statistically significant improvement in the primary endpoint, BCVA, at 13 months in the PBM treatment group when compared to the sham-treatment group (p = 0.02). Now, a sustained, mean increase in ETDRS letter score >5.0 letters from baseline is reported at both the 13- and 21-month timepoints in the PBM-treated subjects BCVA (p < 0.0001). The improvement from baseline in BCVA at 24 months in the PBM treatment group was significantly greater than in the sham group, 5.9 vs 1.0 letters (p = 0.0015). Approximately 58% of the PBM-treated eyes had a >5 letter gain with a mean of 8.5 + 0.5 letter gain.

• HCP Cureblindness and SightLife International have joined forces as one organization to make a greater impact in eye care worldwide. Effective immediately, HCP Cureblindness will acquire the SightLife International Program, the global division of the broader SightLife organization, with full integration of systems, programs and brand to come over the next 12 months. SightLife International and HCP Cureblindness will look for opportunities to partner with SightLife US and Lions Eye Institute for Transplant and Research to support technical training for eye bank personnel and surgeons globally, as well as provide corneal tissue to areas where eye bank development is not feasible.

• Indiana University School of Medicine researchers say they have identified a new therapeutic target that could lead to a more effective treatment of glaucoma. In a newly published paper in Communications Biology, researchers found neurons use mitochondria for a steady source of energy, and restoring mitochondrial homeostasis in the diseased neurons can protect the optic nerve cells from being damaged. The team used induced pluripotent stem cells from patients with and without glaucoma as well as clustered regularly interspaced short palindromic repeats, or CRISPR, engineered human embryonic stem cells with glaucoma mutation. They identified glaucomatous retinal ganglion cells suffer mitochondrial deficiency with more metabolic burden on each mitochondrion. For more, see the study results here.

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