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Aldeyra Therapeutics announced positive topline results from the Phase 3 INVIGORATE-2 clinical trial of 0.25% reproxalap ophthalmic solution (reproxalap), an investigational new drug, in patients with allergic conjunctivitis. Relative to patients treated with vehicle, patients treated with reproxalap reported statistically significant ocular itching score reduction across all 11 prespecified primary endpoint comparisons (P<0.0001 for each comparison) from 110 to 210 minutes in the allergen chamber. The reproxalap-treated patients demonstrated statistically significant reduction from baseline compared to vehicle (P=0.004) for the key secondary endpoint of investigator-assessed ocular redness over the duration of the allergen chamber. For more, see the study results here.
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The American Medical Association (AMA) House of Delegates adopted policy during its annual meeting calling for greater regulatory oversight of insurers’ use of augmented intelligence (AI) in reviewing patient claims and prior authorization requests. While the AMA supports automation to speed up the prior authorization process and cut down on the burdensome paperwork required by physicians, it says prior authorization is overused, costly, inefficient and responsible for patient care delays. The newly adopted policy calls for health insurers utilizing AI technology to implement a thorough and fair process that is based on clinical criteria and includes reviews by physicians and other health-care professionals with expertise for the service under review and no incentive to deny care.
- ZEISS Vision Care introduced ZEISS Warm Eye Masks, individually wrapped and disposable eye masks designed to refresh and soothe dry, tired eyes. The masks use gentle heat to soothe, relax and stimulate the meibomian glands. The warmth helps to unblock the glands, which support natural tear fluid production. The masks instantly selfheat to a temperature that lasts 15 minutes. Because they are individually wrapped, the masks are hygienic and convenient for use at home or on-the-go, and are designed to fit any face with soft ear loops. ZEISS Warm Eye Masks are now available in North America.
- Alcon reported the results from its Alcon Eye On Cataract Survey. The results reveal cataract surgery not only improves vision, but also can help turn back the clock for patients’ vision, with almost half (45%) of post-surgery patients reporting they have the vision of someone younger. Across the 10 markets surveyed (Australia, Brazil, China, Germany, India, Italy, Japan, Spain, South Korea and the United States), vision ties with mobility as the second most important quality of aging (83%) with only memory scoring higher at 84%. The survey was conducted between March and April 2023 and set out to evaluate vision and cataract insights among the world’s rapidly aging population. Survey participants included pre- and post-cataract surgery patients aged 50+ who had received their diagnosis within the last 5 years and people aged 50+ who have not been diagnosed with cataract(s). For more, see the survey results here.
- Bausch + Lomb announced the US launch of PreserVision AREDS 2 Formula soft gels plus coenzyme Q10 (CoQ10). Developed as a convenient two-in-one option, PreserVision AREDS 2 Formula eye vitamins plus CoQ10 is the first eye vitamin that combines the exact nutrient formula recommended by the National Eye Institute to help reduce the risk of moderate to advanced AMD progression in AMD patients with CoQ10 to help support heart health. This formula includes certain amounts of lutein and zeaxanthin, two important antioxidant carotenoids that have been clinically shown to help reduce the risk of progression in people with moderate to advanced AMD. The eye vitamin is available at most major retailers nationwide, including Walmart, Target and Amazon.
- Adverum Biotechnologies announced an agreement granting Ray Therapeutics a non-exclusive, royalty bearing license of Adverum’s proprietary AAV.7m8 intravitreal vector capsid to be used in conjunction with Ray’s optogenetics payload. The agreement highlights the value of Adverum’s AAV.7m8 gene therapy platform in a variety of ocular gene therapy indications. Under the terms of the agreement, Adverum grants Ray Therapeutics a worldwide, non-exclusive license of AAV.7m8 for the prevention, treatment, diagnosis or amelioration of any ocular disorder utilizing Ray’s (RTx-015) optogenetics approach.
- MediPrint Ophthalmics completed its SIGHT-2 dose-finding Phase 2b Group 1 (low dose) study for its proprietary drug-eluting contact lens for glaucoma. This is the first of potentially three doses in the second study of its clinical program SIGHT (Sustained Innovative Glaucoma and ocular Hypertension Treatment) for LL-BMT1, a preservative-free weekly medicated contact lens releasing bimatoprost to treat open-angle glaucoma and ocular hypertension. An interim analysis of the SIGHT-2 Group 1 results for efficacy shows that the LL-BMT1 (low dose) lens achieved a clinically meaningful reduction in IOP of about 5.5 mm Hg and was comparable to the reference treatment. Additionally, there was a sharp decline in IOP in the first week (-14% from baseline) with the LL-BMT1 (low dose) lens. IOP declined further in the second week (-18% from baseline) and in the third week (-19% from baseline).
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