• Allergan, an AbbVie company, announced the FDA approved a twice-daily dosing option of VUITY (pilocarpine HCl ophthalmic solution) 1.25% in adults with presbyopia. A second dose (one additional drop in each eye) may be administered 3-6 hours after the first dose. With the approval of twice-daily dosing, the duration of effect of VUITY may be extended for up to 9 hours. The approval is based on results from the double-masked Phase 3 VIRGO trial. The primary endpoint of the proportion of participants gaining three lines or more in mesopic (low light), high contrast, binocular distance corrected near visual acuity with no more than 5-letter loss in low light corrected distance visual acuity at Day 14, Hour 9 (3 hours after the second drop) vs the vehicle (placebo) was met (35.1% vs 7.8%, p<0.0001).

• Pixium Vision SA announced the FDA granted Breakthrough Device Designation to the company's Prima System, a photovoltaic substitute of photoreceptors providing simultaneous use of the central prosthetic and peripheral natural vision implanted in human patients with atrophic dry AMD to partially restore their vision. Under the program, Pixium Vision will have the opportunity to interact with the FDA's experts during the premarket review phase of the Prima System to identify areas of agreement in a timely way, and the company could also receive prioritized review of the regulatory submission. Upon approval in the United States, outpatient and inpatient reimbursement options will be available.

• EyePoint Pharmaceuticals completed enrollment in the Phase 2 Durasert and Vorolanib in Ophthalmology 2 (DAVIO 2) clinical trial evaluating EYP-1901 as a potential 6-month maintenance treatment for wet AMD. All patients were previously treated with a standard-of-care anti-VEGF therapy and were randomly assigned to one of two doses of EYP-1901 or to an aflibercept on-label control. EYP-1901 is delivered with a single intravitreal injection in the physician's office. The primary efficacy endpoint of the DAVIO 2 trial is change in BCVA compared to the aflibercept control, 6 months after the EYP-1901 injection. Secondary efficacy endpoints include change in central subfield thickness as measured by optical coherence tomography, number of eyes that remain free of supplemental anti-VEGF injections, number of aflibercept injections in each group and safety.

• Théa Open Innovation (TOI), a sister company of Laboratoires Théa, and Galimedix Therapeutics, signed a licensing agreement. Under the terms of the agreement, Galimedix will grant TOI exclusive rights for the development and commercialization of GAL-101, Galimedix’s lead disease-modifying compound, for the topical and oral treatment of dry AMD, glaucoma and other ophthalmic indications. While TOI will fully fund the remaining development of GAL-101 in dry AMD and take charge of the registration and commercialization of the drug, Galimedix will remain responsible for the mid-stage clinical trials. The company received feedback from the FDA to continue the development through Phase 2 or Phase 2/3. The first patient is planned to be enrolled in 2024.

• Ocugen Inc. announced the FDA approved enrolling pediatric patients in the ongoing OCU400 Phase 1/2 trial who have: retinitis pigmentosa (RP) associated with NR2E3 and RHO mutations; and Leber congenital amaurosis (LCA) associated with CEP290 gene mutations. OCU400 is the company’s gene-agnostic modifier gene therapy product based on nuclear hormone receptors gene, NR2E3. OCU400 resets altered/affected cellular gene-networks and establishes homeostasis — which has the potential to improve retinal health and function in patients with inherited retinal diseases. Enrollment of adult RP patients in the Phase 1/2 trial is complete, and enrollment continues among patients with LCA. The company plans to initiate the Phase 3 trial near the end of 2023.

• Researchers supported by the NEI are developing artificial intelligence (AI)/machine learning-based systems that not only screen for AMD but also predict which patients will likely progress to late AMD within 2 years. The systems also evaluate separately one’s risk for developing late wet (neovascular) AMD from one’s risk for late dry (geographic atrophy) AMD. The systems can deliver clinical and diagnostic information on their own, without the need for expert interpretation. They are developed by training a deep convolutional neural network, a type of AI, on large datasets comprising thousands of patients with known outcomes. The network extracts features from these patients’ retinal images, and imaging data are then combined with other patient data such as age, smoking status, genetic profile and eye disease outcome. With enough data, the network begins to detect patterns that can aid screening and prediction. For more on these systems, click here.

• Researchers in Austria have found evidence for a previously suspected connection: reduced oxygen transport to the retina leads to damage to the fine blood vessels, causing diabetic retinopathy. The research led by Gerhard Garhöfer, MD, of the University Clinic for Clinical Pharmacology at the Medical University of Vienna, said that these finely ramified vessels supplying the retina manage gas exchange and metabolism in tissues all over the body, from the kidneys to the toes. The condition they are in can indicate not only diseases of the eye, but also various other medical conditions, including type 2 diabetes. For more, see the study results here.

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.