• NovaSight announced the FDA has cleared CureSight, a digital therapy device for amblyopia. The eye-tracking-based system is designed for improving visual acuity and stereo acuity by training the visual system to use both eyes simultaneously, while the user watches any streamed video content of choice through red-blue treatment glasses. Using sophisticated algorithms and eye-tracking technology, CureSight blurs the center of vision of the image that is shown to the strong eye using real-time image processing according to the momentary eye gaze. This encourages the brain to complete the image’s fine details from the amblyopic eye image and trains the two eyes to work as a team. The device is designed to be used at home, and it shares treatment reports with caregivers via a web portal.

• Alimera Sciences announced post-hoc analyses from the PALADIN Phase 4 Safety Study demonstrate that median treatment frequency in diabetic macular edema patients treated with ILUVIEN (fluocinolone acetonide intravitreal implant) 0.19 mg was lower than from patients on other regimens. ILUVIEN treatment significantly reduced the number of eyes requiring anti-VEGF, corticosteroid and laser therapy and reduced the total number of therapies administered by 46%, and 25% of eyes remained supplemental treatment free through 36 months. In addition, the data demonstrates ILUVIEN patients experienced on average an increase in visual acuity, a significant decrease in retinal thickness and a predictable and manageable safety profile over 36 months.

• Aldeyra Therapeutics announced the achievement of the primary endpoint in Part 1 of the Phase 3 GUARD Trial of ADX-2191 (methotrexate injection, USP) for intravitreal administration, an investigational drug candidate for the prevention of proliferative vitreoretinopathy (PVR), a rare sight-threatening retinal disease with no approved therapy. ADX-2191 was statistically superior to historical control for the prevention of retinal detachment due to PVR over 6 months (P=0.024). The results also demonstrated numerical superiority of ADX-2191 over routine surgical care in reducing the dichotomous endpoints of retinal detachment rate over 6 months, hypotony, complete retinal attachment by 6 months, macular attachment by 6 months and epiretinal membrane formation (overall P=0.047). ADX-2191 received FDA orphan drug designation and FDA Fast Track designation for the prevention of PVR and received FDA orphan drug designation for the treatment of primary vitreoretinal lymphoma and retinitis pigmentosa. 

• Apellis Pharmaceuticals released new data from the 24-month Phase 3 OAKS study of pegcetacoplan, an investigational targeted C3 therapy, for the treatment of geographic atrophy (GA) secondary to AMD. Two post hoc analyses of microperimetry data showed positive trends with increasing effects over time, demonstrating both monthly and every-other-month (EOM) pegcetacoplan treatment preserved visual function of retinal cells near the GA lesion border compared to sham. At 24 months, patients in both monthly (0.564 dB; p=0.0650) and EOM (0.707 dB; p=0.0202) pegcetacoplan treatment groups lost less retinal sensitivity compared to the sham group over 24 months with increasing effects over time. For more, see the study results here.

• Kubota Vision reported positive results from a post hoc analysis of the Phase 3 clinical trial of the investigational visual cycle modulator emixustat hydrochloride (emixustat) in patients with Stargardt disease. Prompted by planned subgroup analyses suggesting that emixustat subjects with smaller atrophic lesions at baseline had a reduced rate of progression compared to placebo subjects, post hoc analyses were performed to further investigate this finding. A multi-factor analysis was performed on the subgroup of subjects with smaller lesions at baseline, controlling for the baseline factors identified in univariate and multi-factor analyses to affect lesion progression in this subgroup. This analysis determined that emixustat treatment resulted in a 40.8% reduction in lesion progression compared to placebo at Month 24 (p=0.0206, emixustat n=34, placebo n=21).

• Tarsus Pharmaceuticals reported the results from the Saturn-2 pivotal Phase 3 trial of TP-03 (lotilaner ophthalmic solution, 0.25%) in Demodex blepharitis patients. Results from the trial revealed statistically significant (P < .01) complete collarette cure (CC) (0-2 collarettes) and clinically meaningful CC (≤10 collarettes), along with reduction of lid erythema and eradication of mites, which was achieved on or before Day 43 between lotilaner and vehicle. The majority of patients stated that both lotilaner and vehicle drops were neutral to very comfortable. Tarsus submitted a new drug application to the FDA for TP-03 including the Saturn-1 and Saturn-2 pivotal trial results, both of which met the primary endpoint and all secondary endpoints.

• Aura Biosciences reported interim Phase 2 data evaluating the safety and efficacy of suprachoroidal administration using its first virus-like drug conjugate (VDC) product candidate, belzupacap sarotalocan (AU 011), for the first-line treatment of patients with early-stage choroidal melanoma (indeterminate lesions and small choroidal melanoma). With an average of 6 months follow up in patients that received three cycles of therapy, data showed a statistically significant reduction in the tumor growth rate (-0.296 mm/yr, p = 0.0007) compared to each patient’s documented growth rate at study entry, and an 88.9% (8/9) tumor control rate. For more, see the study results here.

• Cardinal Health is launching a new suite of revenue cycle management solutions and consulting services to help specialty physician practices simplify payer contracting, streamline prior authorization and maximize financial performance. Cardinal Health is collaborating with PayrHealth and eBlu Solutions to offer a payer contracting solution and prior authorization solution, respectively. Advanced Practice Analytics combines clinical, financial and operational data to provide actionable insights through up-to-date dashboards with drill-down capabilities, allowing practices to isolate root cause issues that impact revenue cycle performance. The data helps providers improve their operational processes, cash flow, reimbursement performance and payer negotiations.

• Sight Sciences announced Clinical Ophthalmology published data from a subgroup analysis of the OLYMPIA trial, which showed a single treatment with the TearCare System led to superior symptoms relief across the primary symptoms endpoints — Ocular Surface Disease Index (OSDI), Symptom Assessment in Dry Eye (SANDE) and Eye Dryness (ED) — in patients with severe forms of dry eye disease due to meibomian gland dysfunction. At one month, TearCare demonstrated a statistically significant improvement in all primary and secondary endpoints. In the subset of more severe patients (MGSS <7) with similar OSDI baseline, those receiving TearCare treatment (n=56) achieved an OSDI score reduction of -31.0. For more, see the study results here.

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