• Alcon announced the open-platform NGENUITY 1.5 Digital 3D Visualization System is now available in the United States. NGENUITY 1.5 provides sharp visualization with usability, color, contrast and magnification enhancements. It also offers connectivity to ARGOS Biometer diagnostic images to precisely overlay incisions, capsulorhexis, IOL centration, toric alignment and more. NGENUITY 1.5 will be featured at the ASCRS annual meeting, and data will also be presented demonstrating how surgeons can benefit from using ARGOS and NGENUITY in their practices. 

• Centricity Vision received 510(k) clearance from the FDA for the new ZEPTOLink IOL Positioning System. The new platform seamlessly integrates the ZEPTO precision pulse capsulotomy technology with any phaco system to streamline cataract surgery. ZEPTOLink uses suction and irrigation provided by the phaco system, enabling surgeons to fully control the ZEPTO handpiece apposition, suction, energy delivery and release using the phaco foot pedal. Some features include a small ergonomic console that attaches to any phaco system; modern touchscreen display with voice-supported functions; a dedicated ZEPTOLink handpiece for efficient set-up, priming and operation by a single person all within the sterile field; and ZEPTO technology for precise, consistent and centered capsulotomies with 360° IOL overlap. ZEPTOLink will be introduced and demonstrated at the ASCRS annual meeting. Centricity Vision is planning a phased approach for the US market roll-out of ZEPTOLink, with a broader commercial launch later this year.

• Norlase received both FDA 510(k) clearance and CE Mark approval for the ECHO Green Pattern Laser photocoagulator. ECHO is a portable scanning laser photocoagulator utilizing MEMS technology. The laser and scanner are completely integrated into a single delivery device that attaches to compatible slit lamps. Other features of the ECHO include a full pattern palette that includes grids, circle, and triple arc; a μSec Mode for tissue-sparing treatment; a fiberless design to minimize costly service repairs and disruption; a wireless user interface; and voice control of patterns and parameters.

• Visus Therapeutics presented key topline data from the pivotal Phase 3 BRIO-I clinical trial at Eyecelerator at the ASCRS annual meeting. The study evaluating the safety and efficacy of BRIMOCHOL PF, a preservative-free ophthalmic solution for the treatment of presbyopia, met its primary and secondary endpoints. BRIMOCHOL PF successfully achieved the prespecified FDA primary endpoint based on the proportion of subjects achieving >15 ETDRS letter gain in binocular near visual acuity without a loss of ≥5 letters at distance across all time points through Hour 6 (carbachol p=0.006; brimonidine p=0.039). Topline results from BRIO-II, an ongoing Pivotal Phase 3, 6-month plus 6-month safety and efficacy interim study are expected in 2H 2023. Following the read-out of the vehicle-controlled BRIO-II, it is the company’s current expectation to file a new drug application (NDA) with the FDA in 2H 2024. 

• Astellas Pharma and IVERIC Bio announced the companies entered into a definitive agreement under which Astellas through Berry Merger Sub, a wholly-owned subsidiary of Astellas US Holding, has agreed to acquire 100% of the outstanding shares of Iveric Bio for US$40 per share in cash for a total equity value of approximately US$5.9 billion. In the acquisition, Iveric Bio will become an indirectly wholly-owned subsidiary of Astellas. The companies expect to complete the acquisition in the second quarter of Astellas’ fiscal year 2023.

• Théa Pharma issued a statement announcing that its portfolio of products acquired last year from Akorn — AcellFX, Akten, AzaSite, Betimol, Cosopt, Cosopt PF and Zioptan — are not impacted by a voluntary nationwide recall initiated by Akorn. None of these products are manufactured at Akorn’s US facilities that have been closed. On April 26, 2023, the Akorn Trustee initiated a voluntary recall of various within-expiry human and animal products as a result of its US facility closures and discontinuation of the Quality activities of these marketed products. 

• VMG Health acquired BSM Consulting, a specialist health-care consulting firm with offices in Reno, Nev., and Phoenix. VMG Health is owned by VMG employees and Northlane Capital Partners. The acquisition brings together BSM’s long-standing reputation of expert business management consulting and operational solutions, and VMG Health’s expertise in health-care transactions, compliance and physician alignment. BSM adds new services, including subscription-based membership programs, recruitment and leadership development resources that will advance VMG Health’s commitment to providing a broader array of solutions to meet the needs of its clients.

• Harrow announced the completion of the transfer to Harrow of the NDAs for ILEVRO (nepafenac ophthalmic suspension) 0.3%, NEVANAC (nepafenac ophthalmic suspension) 0.1%, and MAXIDEX (dexamethasone ophthalmic suspension) 0.1%. Harrow expects to complete the transfer of the NDAs for the two remaining products, VIGAMOX (moxifloxacin hydrochloride ophthalmic solution) 0.5% and TRIESENCE (triamcinolone acetonide injectable suspension) 40 mg/ml, by year-end. Product orders for ILEVRO, NEVANAC, and MAXIDEX can be made directly through Harrow’s customer service ordering partner, Cardinal’s Cordlogistics, which includes a wholesaler distribution system encompassing McKesson and AmerisourceBergen. 

• Compulink Healthcare Solutions will have its new graphical user interface design on display at ASCRS this week. The graphical user interface includes elements that are pleasing to the eye and add to ease of use. Efficiency features such as panel displays and hover menus have been added throughout the software for quicker access to information and functions.

• The FDA cleared Atsena Therapeutics’ investigational NDA for a Phase 1/2 clinical trial of ATSN-201 in patients with X-linked retinoschisis (XLRS). ATSN-201 leverages one of the company’s novel spreading capsids, AAV.SPR, to overcome the challenges associated with intravitreally delivered AAVs in the treatment of XLRS. AAV.SPR spreads laterally beyond the subretinal injection site to enable safe and efficient transduction of the central retina (where schisis cavities predominate in XLRS patient retinas) when injected into areas outside the macula. The Lighthouse Study, a Phase 1/2, open-label, dose-escalation clinical trial, will evaluate subretinal injection of ATSN-201 in male patients ages 6-65 with a clinical diagnosis of XLRS caused by pathogenic or likely pathogenic mutations in RS1.

• Formosa Pharmaceuticals and AimMax Therapeutics announced the submission of a NDA to the FDA for APP13007, a novel aqueous nanosuspension formulation of the potent corticosteroid, clobetasol propionate (0.05%), for the treatment of inflammation and pain following ocular surgery. This proprietary homogeneous nanosuspension has a solution-like appearance which offers comfort to the eyes and enhanced drug penetration into ocular tissues.

• BVI completed enrollment of its US Investigational Device Exemption (IDE) clinical study for FINEVISION HP, its latest hydrophobic trifocal IOL. FINEVISION HP is the third generation in the FINEVISION family, featuring BVI’s proprietary hydrophobic material and two novel patented CoPODize technologies enabling Convolution and Apodization concepts on the entire optic surface. The study marks the final implantation of the 539th patient enrolled in the prospective, multicenter, randomized, masked, controlled IDE clinical study. Patients will be followed to evaluate the safety and performance of the FINEVISION HP IOL, with the results to form the basis for a regulatory submission to obtain marketing approval in the United States.

• Lions Eye Institute for Transplant and Research and SightLife have come together under a new name: Lions World Vision Institute. Now as one organization, Lions World Vision Institute offers a broader, worldwide network of eye banks, physicians, researchers and community-based services to exponentially increase its impact. This transition marks the full integration of the two nonprofit eye banks, which came together in August 2022 and now serve as the largest eye bank, tissue recovery, preventive care and ocular research center in the world. The newly named organization will be headquartered in Tampa, Fla., with satellite offices throughout Florida, Louisiana, Washington state, California and Pennsylvania, and additional tissue recovery services in Montana, Idaho and Wisconsin. 

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.