• The "Global Minimally Invasive Glaucoma Surgery (MIGS) Devices Market Size, Share & Trends Analysis Report by Product (Valves, Glaucoma Drainage Implant), Surgery Method, End-use, Region, and Segment Forecast 2024-2030" report (ResearchAndMarkets.com) shows the global MIGS devices market size is anticipated to reach USD 781.2 million by 2030, registering a compound annual growth rate (CAGR) of 5.36% from 2024 to 2030. The factors propelling market growth include increasing awareness about minimally invasive surgery, technological advancements, the expanding geriatric population and the continuous development of health-care infrastructure. The glaucoma drainage implant segment dominated the market with a revenue share of more than 33% in 2023. Moreover, the stent segment is anticipated to grow at the fastest CAGR during the forecast period. In addition, based on surgery method, the trabecular meshwork bypass segment held the largest market share in 2023. For more highlights from the report, click here.

• Outlook Therapeutics received written agreement from the FDA under a Special Protocol Assessment (SPA) for the NORSE EIGHT clinical trial protocol evaluating ONS-5010 in neovascular AMD subjects. Additionally, Outlook Therapeutics entered into securities purchase agreements with certain institutional and accredited investors for up to $172 million in gross proceeds to fund the advancement of ONS-5010. The FDA reviewed and agreed upon the NORSE EIGHT trial protocol pursuant to the SPA. If the NORSE EIGHT trial is successful, it would satisfy the FDA’s requirement for a second adequate and well-controlled clinical trial to address fully the clinical deficiency identified in the Complete Response Letter. NORSE EIGHT will be a randomized, controlled, parallel-group, masked, non-inferiority study of approximately 400 newly diagnosed wet AMD subjects randomized in a 1:1 ratio to receive 1.25 mg ONS-5010 or 0.5 mg ranibizumab intravitreal injections at Day 0 (randomization), Week 4 and Week 8 visits. The primary endpoint will be mean change in BCVA from baseline to Week 8. 

• Rayner entered into a definitive agreement to acquire Swiss-based This AG, the inventor, developer and manufacturer of Sophi phaco emulsification machines. Rayner says the acquisition will enhance its selection of products for cataract surgery, adding phaco technology to its product portfolio and enabling provision of a full offering also encompassing IOLs, ophthalmic viscosurgical devices (OVDs), eyedrops, pharmaceuticals, digital tools and single-use recyclable instruments. The acquisition closed on Jan. 17.

• REGENXBIO Inc. announced positive interim data from the Phase 2 AAVIATE trial of ABBV-RGX-314 for the treatment of wet AMD using suprachoroidal delivery. The data showed that ABBV-RGX-314 continues to be well tolerated in more than 100 patients from three dose levels with no drug-related serious adverse events. ABBV-RGX-314 in more than 50 patients at third dose level demonstrated highest reduction in treatment burden with 80% reduction in annualized injection rate and 50% of patients remaining injection-free. There were zero cases of intraocular inflammation observed in patients that received short-course prophylactic topical steroid eyedrops. ABBV-RGX-314, being developed in collaboration with AbbVie, is also being investigated as a potential one-time gene therapy for the treatment of diabetic retinopathy and other chronic retinal conditions. For more, see the study results here.

• Coherus BioSciences entered into an agreement to divest its CIMERLI (ranibizumab-eqrn) ophthalmology franchise, inclusive of CIMERLI and its supporting commercial infrastructure, to Sandoz for upfront, all-cash consideration of $170 million plus an additional amount for CIMERLI product inventory and subject to customary working capital adjustments at the closing date. This divestiture includes Coherus’ CIMERLI biologics license application, ophthalmology sales and select field reimbursement teams, CIMERLI product inventory on hand, and access to proprietary commercial software. Closing is anticipated in the first half of 2024.

• iuvo BioScience acquired Promedica International, a California Corp. The combined organization will support all aspects of ophthalmic clinical research, from front of the eye to back of the eye. The combined business will deliver end-to-end laboratory, consulting and clinical development services with a focus in ophthalmology and the broader medical device market. iuvo and PMI will support customers from the early pre-clinical and laboratory stages through all phases of clinical development within one integrated organization.

• Researchers at the National Eye Institute improved a crucial step in the production of retinal pigment epithelium (RPE), a tissue they grow in the lab from patient blood cells and are testing in a clinical trial as treatment for AMD. Their technique combines electrochemical cell measurements enhanced by mathematical modeling to directly assess epithelial cell membranes and tissue barrier health. The technique, which the researchers call 3-probe electrochemical impedance spectroscopy, or 3 P-EIS, provides additional physiologic parameters that are useful in manufacturing RPE tissues used in cell therapies. In addition, 3 P-EIS provides greater resolution data, with respect to epithelial function in drug testing and disease modeling protocols. A report about the technique was published in Cell Physiology. The authors plan to use 3 P-EIS for quality control in an ongoing Phase 1/2a clinical trial of patient-derived RPE for AMD. To learn more about this technique, click 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.