• The FDA approved ZEISS Medical Technology’s VISUMAX 800 with SMILE pro software from ZEISS for surgically treating nearsightedness, with or without astigmatism. The femtosecond laser enables fast treatment, creating the lenticule in less than 10 seconds due to a pulse repetition rate of 2 MHz. The femtosecond laser also provides more flexibility for the surgeon and patient, with a smaller footprint and compatibility with a variety of patient beds. In addition, surgeons can utilize a number of workflow enhancements including: the CentraLign centration aid, a computer-controlled function for easy centration; the OcuLign cyclotorsion adjustment to help counter cyclotorsion that may occur; and VISULYZE user nomograms to help surgeons collect and analyze patient data, while also providing detailed nomograms and enabling more control during every surgery.

• NIDEK Inc. announced the commercial launch of the Mirante Scanning Laser Ophthalmoscope for the US market. The Mirante is a multimodal fundus imaging platform that combines high-definition scanning laser ophthalmoscopy and optical coherence tomography (OCT) with ultra-wide-field imaging. The multimodal platform captures high-quality color images, fluorescein angiography (FA), indocyanine green angiography (ICG), fundus autofluorescence, Retro mode images and OCT. The wide-field adapter enables 163° ultra-wide-field imaging with a single image capture. The ultra-wide-field modalities of color, FA, ICG and Retro mode allow detailed evaluation of pathologies from the fovea to the extreme periphery. Combined with 4,096x4,096 pixels imaging quality, ultra 4K HD, the Mirante achieves a wider, enhanced view of the retinal structure and vasculature.

• Iridex Corp. announced the US launch of its next-generation platform Iridex 532 and Iridex 577 Lasers. Both lasers harness multiple treatment modes including continuous-wave and Iridex’s patented MicroPulse Technology and a touchscreen interface providing a wide range of clinical control options and features to optimize the treatment of retinal disorders and glaucoma. Both lasers feature comprehensive treatment reports allowing physicians to create detailed reports of treatment parameters for every procedure; configurable preset filters for simple program management and selection via a preset management tool enabling customizable selections by procedure and by individual doctor; a multi-functional single control knob for console navigation; and MicroPulse laser applications that adds fine control of photothermal effects in laser photocoagulation.

• Harrow announced that VEVYE (cyclosporine ophthalmic solution) 0.1%, a patented, non‑preserved, twice-daily dosed prescription drug based on a “water‑free” semifluorinated alkane eyedrop technology, is now available in the United States. Dispensed in a 10 microliter drop, VEVYE is the first cyclosporine‑based product indicated for treating both the signs and symptoms of dry eye disease. Physicians can send prescriptions for VEVYE, using their EMR, directly to Harrow’s dedicated pharmacy partner, PhilRx. Prescriptions can also be sent to any retail pharmacy. VEVYE is fully stocked in the wholesale distribution channel and can be shipped to any retail pharmacy, generally within 24 hours of order placement. In addition, VEVYE is available directly through the wholesale distributors, including McKesson, Cardinal and Cencora (f/k/a AmerisourceBergen). Harrow has established a VEVYE Patient Access program, under which eligible patients may receive their first VEVYE prescription for as low as $0. Harrow also offers a 100% money-back guarantee for eligible patients.

• Amneal Pharmaceuticals announced the approval and launch of complex generic fluorometholone ophthalmic suspension, USP, 0.1%. The product received 180-day competitive generic therapy exclusivity from the FDA. FML suspension is indicated for the treatment of corticosteroid-responsive inflammation of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe. Adverse drug events reported with the use of fluorometholone ophthalmic suspension 0.1% include short-term inflammatory eye reactions such as eye and eyelid swelling, redness, burning eye pain, itchy eyes; and long-term use effects including elevation of IOP with possible development of glaucoma, infrequent optic nerve damage, cataract formation, vision problems and delayed eye wound healing. 

• The Advanced Research Projects Agency for Health (ARPA-H) announced the Transplantation of Human Eye Allografts (THEA) program, which intends to transplant whole human eyes to restore vision for the blind and visually impaired. To accomplish eye transplant surgery and healing, THEA will leverage emerging microsurgical techniques, coupled with genetic and cell-based therapies, to preserve or regrow nerves from the eye to the brain. These regenerative solutions could help prevent degenerative blindness and are a critical step towards successful whole eye transplantation to restore vision. ARPA-H is emphasizing collaboration across academia and industry to accelerate these discoveries with tools not yet applied to ocular surgery. THEA intends to test and evaluate therapies to repair damaged nerves, to maintain critical structures in the eye, such as the retina and optic nerve viable after damage, and to prevent postoperative inflammation or rejection. 

• OrCam introduced a new AI companion for its MyEye device to provide support for users with visual impairments. The assistive technology features immediate text reading, facial recognition and product identification to dynamic interactions similar to natural conversations. Users can inquire about their surroundings by voice, gesture or tap on the device. OrCam's AI companion is tuned to the individual user, allowing for precise, on-demand responses that cater to the wearer's inquiries. By tapping the device, the user will get a general summary of a scene or document, and if requested, a detailed information of specific matters in real-time. OrCam also unveiled the "Just Ask" smart magnifier feature for its Read 3 device that features an Interactive AI Assistant, designed to support people with vision loss or reading fatigue and throughout vision changes. It functions as a handheld reading companion, as a magnifier or a stationary reader, based on the users' needs. The device captures an image of the text or handwriting the user is interested in — ranging from a book page to a handwritten letter. The "Just Ask" feature also offers a range of interactive options — it summarizes any captured text, and the user can ask follow-up questions related to the text and beyond. 

• Eyenovia Inc. re-acquired the rights to MicroPine in the United States and Canada. MicroPine, an investigational 8 microliter ophthalmic spray of atropine delivered by Eyenovia’s proprietary Optejet device, is being evaluated as a potential treatment for pediatric progressive myopia. As Eyenovia accelerates its commercial capabilities in 2024 with the expanded launch of MydCombi and the anticipated introduction of APP-13007 (pending FDA approval anticipated in March), MicroPine adds a major late-stage asset in a large market with high unmet medical need. Based upon the company’s internal forecast, by acquiring back the MicroPine rights, the overall asset value of the MicroPine program to Eyenovia more than doubles compared to what the company would have been eligible to receive under the original license agreement. Eyenovia will work to accelerate the ongoing CHAPERONE Phase 3 trial and engage with the FDA to explore options to expedite development and registration of MicroPine. 

• The FDA granted Rare Pediatric Disease designation to Atsena Therapeutics’ ATSN-101, the company’s investigational gene therapy being evaluated in an ongoing Phase 1/2 clinical trial in patients with Leber congenital amaurosis caused by biallelic mutations in GUCY2D (LCA1). The FDA previously granted Regenerative Medicine Advanced Therapy designation and orphan drug designation to ATSN-101 for the treatment of LCA1. If a Biologics License Application for ATSN-101 for the treatment of LCA1 is approved by the FDA, Atsena may be eligible to receive a Priority Review Voucher that can be redeemed to receive a priority review for any subsequent marketing application or may be sold or transferred. In addition, the company reported positive 12-month safety and efficacy data from its ongoing Phase 1/2 clinical trial of ATSN-101, which demonstrated clinically meaningful improvements in vision at the highest dose and is well-tolerated 12 months post-treatment. 

• Alkeus Pharmaceuticals reported positive interim data showing gildeuretinol halted Stargardt disease progression for up to 6 years. In its ongoing TEASE-3 clinical trial in early-stage Stargardt disease, the first three teenage patients enrolled in TEASE-3 and treated with oral gildeuretinol acetate remained asymptomatic and free of disease progression for their treatment duration ranging between 2 (one patient) and 6 years (two patients). In the absence of treatment, the patients were projected to begin experiencing vision loss within 2 years, following the same disease trajectory as that of their respective older siblings with identical genetic mutations who had not been treated with gildeuretinol. The primary endpoint of the study is a measure of progression after the first 2 years of treatment. After the initial 2-year treatment, patients can continue to receive gildeuretinol for extended periods. TEASE-3 has enrolled a total of five patients to date with no signs of disease progression while on treatment.

• EyePoint Pharmaceuticals announced the first patient has been dosed in the Phase 2 VERONA clinical trial of EYP-1901 for diabetic macular edema (DME). EYP-1901 is an investigational sustained delivery therapy containing vorolanib, a selective tyrosine kinase inhibitor formulated in bioerodible Durasert E. VERONA is a randomized, controlled, single-masked, Phase 2 trial of EYP-1901 in DME patients previously treated with a standard-of-care anti-VEGF therapy. The three-arm trial is expected to enroll approximately 25 patients assigned to one of two intravitreal doses of EYP-1901 or an aflibercept control. The primary efficacy endpoint of the VERONA trial is time to first supplemental aflibercept injection up to 24 weeks based on established supplement criteria. Secondary endpoints include safety, change in BCVA, change in central subfield thickness as measured by OCT and change in diabetic retinopathy severity scale over time. 

• Aviceda Therapeutics announced the first patient has been enrolled in the GLYCO Phase 2 US clinical trial evaluating the company’s lead ophthalmic candidate AVD-104 for the management of DME. The GLYCO Phase 2 US clinical trial will evaluate the safety and treatment effects of intravitreal AVD-104 in patients with DME. This multi-center, open-label safety and tolerability study will enroll 30 patients to evaluate a low and high dose of AVD-104 with 3-month follow-up. The primary endpoint will be the incidence and severity of ocular and systemic adverse events. Secondary endpoint analyses will include standard evaluations of treatment efficacy, including macular thickness and vision. In addition, Aviceda announced positive topline data of Part 1 of the Phase 2/3 SIGLEC trial for AVD-104 in patients with geographic atrophy (GA) secondary to AMD, showing positive safety and efficacy outcomes, which were observed at 3 months after a single dose of AVD-104. AVD-104 was well-tolerated in all patients, with no drug-related ocular or systemic serious adverse events detected. Substantial slowing of GA lesion growth was observed, and a majority of study subjects showed functional improvement that was sustained at 3 months after a single injection of AVD-104. The data supports the initiation of Part 2 of the Phase 2/3 SIGLEC trial.

• Tarsier Pharma received agreement from the FDA under a Special Protocol Assessment for the clinical trial protocol and planned statistical analysis of the Tarsier-04 Phase 3 trial to evaluate TRS01 eyedrops for the treatment of non-infectious uveitis including uveitic glaucoma. Tarsier received written agreement from the FDA that the clinical trial protocol and planned statistical analysis of the Tarsier-04 Phase 3 trial of TRS01 address objectives supporting regulatory submission and a potential future marketing application in this indication. Tarsier-04 will be a multi-center, randomized, double-masked, active-controlled Phase 3 trial designed to evaluate the efficacy and safety of TRS01 eyedrops in non-infectious uveitis including patients with uveitic glaucoma.  

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.