• Genentech, a member of the Roche Group, announced positive topline long-term results from the global Phase 3 BALATON and COMINO studies evaluating extended treatment intervals with Vabysmo (faricimab-svoa) in macular edema due to branch and central retinal vein occlusion (BRVO and CRVO). From weeks 24 to 72, all people in both studies received Vabysmo using a treat-and-extend dosing regimen, which allows tailoring of their treatment interval according to the individual patient's response to treatment. Data showed people treated with Vabysmo extended their treatment intervals up to every 4 months while maintaining the vision gains achieved in the first 24 weeks of the trials. Vabysmo continued to show robust and sustained drying of retinal fluid from baseline up to week 72, as measured by reduction in central subfield thickness. In both studies, Vabysmo was generally well-tolerated and the safety profile was consistent with previous trials. If approved by the FDA, RVO would be the third indication for Vabysmo in addition to wet (neovascular) AMD and diabetic macular edema. 

• Alphaeon Credit, a third-party financing company in health care, announced a strategic alliance with iOR Partners, a company dedicated to the development of turnkey office-based surgery suites, that offers vision providers exclusive financing rates, enhancing the in-office surgery experience for patients. As part of the partnership, iOR provider partners will benefit from special Alphaeon Credit rates; enhanced credit limits and approval rates where Alphaeon Credit’s offerings will be available to iOR provider partners; a revolving line of credit; and a dedicated team of health-care financing experts. Providers not currently offering Alphaeon Credit as a payment option can enroll here.

• Regeneron Pharmaceuticals announced the first presentation of positive 2-year (96 weeks) results for EYLEA HD (aflibercept) Injection 8 mg from the pivotal PULSAR trial, demonstrating sustained visual and anatomic improvements with 12- and 16-week dosing regimens, compared to EYLEA (aflibercept) Injection in patients with wet AMD. EYLEA HD demonstrated durable vision gains at extended dosing intervals, helping to reduce the treatment burden for patients. Efficacy results for EYLEA HD patients who completed the 2-year follow-up were as follows: Among all patients, 88% were on a ≥12-week dosing interval at the end of 2 years, with 71% meeting the extension criteria for ≥16-week dosing intervals. In addition, of patients assigned to ≥16-week dosing regimen at baseline, 78% were eligible for ≥16-week dosing at the end of 2 years, with 53% eligible for ≥20-dosing week intervals.  

• OKYO Pharma Limited filed an investigational new drug (IND) application with the FDA for the development of OK-101 to treat neuropathic corneal pain (NCP). Study enrollment is planned to commence during Q1 2024 following IND allowance by the FDA. The 40-patient open-label trial will evaluate the safety and efficacy of OK-101 for NCP in a real-world clinical setting. In addition, OKYO announced that OK-101, presently in a 240-patient double-blind placebo-controlled Phase 2 trial in patients with dry eye disease (DED), is showing a positive safety profile. More than 95% of randomized DED patients completed 4 weeks of dosing in the planned 12-week Phase 2 trial, with 72% of randomized DED patients completing 8 weeks and 7.1% of patients completing the entire 12-week trial. Topline efficacy and safety data will be released in December 2023.

• In recognition of World Sight Day on Oct. 12, Prevent Blindness and the Prevention of Blindness Society of Metropolitan Washington will host a vision screening event and Congressional lunch briefing on Capitol Hill. During this event, members of Congress, legislative staff and the public will have the opportunity to receive a free vision screening and learn about policies that promote vision and eye health in professional and occupational settings. The event is free and open to the public and is sponsored by Horizon Therapeutics, Genentech and AbbVie. For more information, click here. 

• AEYE Health, a provider of artificial intelligence (AI)-based diabetic retinopathy screening, announced it has reduced the processing time for its AEYE-DS diabetic retinopathy screening system to under 5 seconds. This improvement is the result of smarter utilization of computing resources that accelerate the execution of the AI algorithms. AEYE-DS requires only one image per eye and rarely requires dilation, the company says. This incremental improvement in exam processing time makes it even faster and helps primary care providers further reduce screening times.

• Innovent Biologics announced the first patient with neovascular AMD (nAMD) has been successfully dosed in the Phase 3 clinical study (STAR) of efdamrofusp alfa (IBI302), a recombinant fully human anti-VEGF and anti-complement bispecific fusion protein. The study will evaluate the efficacy and safety of intravitreal 8 mg IBI302 in subjects with nAMD to support a potential new drug application (CTR20232229, ClinicalTrials.gov Identifier: NCT05972473). A total of 600 subjects will be enrolled and randomized to the 8mg IBI302 arm and 2mg aflibercept arm in a 1:1 ratio. The primary endpoint is change from baseline in BCVA letters in the study eye based on an average at week 44, 48 and 52. All subjects will continue to receive intravitreal injections up to Week 96, with a final study visit at Week 100. 

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.