• Topcon Healthcare introduced the TEMPO perimeter, which features a novel binocular approach that makes visual field testing fast and fluid for patients. TEMPO can function in ambient light and is designed to reduce fatigue for patients and operators. The perimeter’s binocular feature can test the right and left eyes separately and randomly present the test object to either eye in a nonocclusion manner without the examinee being aware of which eye is being tested. TEMPO can be connected to Topcon’s Harmony image and data management solution, allowing physicians to view OCT, fundus photography and perimetry data on a single screen. Harmony’s DICOM Modality Worklist functionality eliminates redundant patient data entry, transcription errors and duplicates.

• Lumenis launched OptiPLUS, a dual frequency radiofrequency (RF) device that delivers heat across different tissue layers. OptiPLUS is a complementary device to Lumenis’ OptiLIGHT technology, which targets the root cause of dry eye disease (DED). While OptiLIGHT relies on a light-based technology, OptiPLUS employs a RF energy. The dual-frequency RF technology enables energy penetration to different skin depths, heating the superficial layer to promote collagen formation and stimulate peri-orbital skin rejuvenation while also reaching into the deeper tissue to target the meibomian glands. A monopolar electrode ensures optimized contact with the delicate contours in the peri-orbital area. 

• ModMed announced the availability of a single-screen SOAP note into its EHR for eye care, EMA, providing ophthalmologists with a user interface that can simplify and streamline their workflow. Reviewing a patient's medical history, documenting findings and plans, and editing when needed are all handled on a single screen, reducing the need to click and scroll through various sections of the EHR to document a clinical visit. The interface's resemblance to traditional paper-based documentation is designed to further increase efficiency. Physicians can use the ModMed single screen on an iPad or via a desktop web browser.

• The FDA granted Breakthrough Device designation to Toku Inc.’s patented AI-powered CLAiR technology. If cleared by the FDA, the CLAiR platform will be the first medical device in the US market that can provide affordable, point-of-care and non-invasive evaluation for risk of cardiovascular disease (CVD) using fundus retinal images through a routine eye exam, the company says. The CLAiR technology is designed to integrate readily with existing retinal imaging cameras to provide real-time CVD risk assessments with accuracy comparable to traditional cardiovascular risk assessment tools. The technology can interpret the many tiny signals conveyed through retinal images of blood vessels to identify elevated cardiovascular risk that may be caused by genetics or risk factors such as hypertension or high cholesterol. These results can then be shared with the patient’s primary care physician, who can initiate a comprehensive cardiovascular evaluation. 

• Aldeyra Therapeutics entered into an exclusive option agreement with AbbVie Inc. Under the terms of the agreement, AbbVie has the option to acquire a co-exclusive license to develop, manufacture, and commercialize reproxalap in the United States and an exclusive license to develop, manufacture, and commercialize reproxalap outside the United States. Aldeyra will receive a non-refundable option fee of $1 million and an upfront payment of $100 million less option fees if AbbVie chooses to exercise the option. Under the terms of the license agreement, Aldeyra would be eligible to receive up to $300 million in regulatory and commercial milestone payments, inclusive of a $100 million milestone payment upon FDA approval of reproxalap in DED. In the United States, Aldeyra and AbbVie would share profits and losses from the commercialization of reproxalap according to a split of 60% for AbbVie and 40% for Aldeyra; for markets outside the United States, Aldeyra would be eligible to receive tiered royalties on net sales of reproxalap. 

• RxSight Inc. announced product updates at AAO 2023. One of the presentations (by Steven Slade, MD) reported clinical results using the LAL+, a new addition to the Light-Adjustable Lens (LAL) family that will become available in the first quarter of 2024. The LAL+ has a built-in optical feature that is designed to further extend the depth of focus before light treatments, while preserving the LAL’s quality vision. In addition, RxSight’s reconfigured Light Delivery Device (LDD) was also on display. While providing the same functionality and outcomes as the standard LDD, this compact model has a smaller footprint to address global practice space constraints.

• Apellis Pharmaceuticals announced data from the GALE extension study following 3 years of continuous treatment with SYFOVRE (pegcetacoplan injection), an FDA-approved treatment for geographic atrophy (GA) secondary to AMD. SYFOVRE continued to demonstrate increasing treatment effects over time. In Year 3, SYFOVRE (all p-values nominal): Reduced GA lesion growth with both monthly (35%; p<0.0001) and every-other-month (EOM) (24%; p<0.0001) treatment compared to the projected sham arm; reduced nonsubfoveal GA lesion growth with both monthly (42%; p<0.0001) and EOM (28%; p=0.0015) treatment compared to the projected sham arm; and reduced GA lesion growth by 19% (p<0.0001) after 1 year of SYFOVRE treatment (combined monthly and EOM), compared to the sham treatment period, in patients who crossed over from the sham group.

• Astellas Pharma announced results from the GATHER2 Phase 3 clinical trial, demonstrating IZERVAY (avacincaptad pegol intravitreal solution) continued to reduce the rate of GA lesion growth for both every month and EOM dosing vs sham through 2 years of treatment in patients with GA secondary to AMD. The GA treatment benefit with IZERVAY vs sham was observed as early as 6 months, continued to increase over time through 2 years and more than doubled over 2 years compared to year 1. IZERVAY dosed EM through 2 years demonstrated a statistically significant year-over-year reduction of 14% in the mean rate of GA growth at 2 years from baseline vs sham (p=0.0165), the primary objective of the year 2 analyses from GATHER2. In addition, EOM dosing of IZERVAY, after a year of monthly dosing, resulted in a reduction of 19% in the mean GA growth rate at 2 years vs sham (nominal p-value=0.0015). For more, see the study results here.

• Kodiak Sciences announced its Phase 3 GLOW superiority study evaluating tarcocimab tedromer 5 mg in moderately severe to severe NPDR met its 1-year primary endpoint. The primary endpoint and all key secondary endpoints met with high statistical significance in the GLOW study. With 6-month dosing of all patients, tarcocimab and the ABC platform continue to demonstrate differentiated durability. Following dialogue with US regulatory authorities, Kodiak plans to conduct one additional pivotal study with a commercial formulation of tarcocimab. Kodiak paused further development of tarcocimab last summer after its GLEAM and GLIMMER studies in diabetic macular edema did not meet their primary endpoint, in order to evaluate learnings from its pivotal BEACON study in patients with macular edema due to retinal vein occlusion and from its GLOW study. For more, see the study results here.

• PolyActiva reported positive interim results from an ongoing Phase 2a clinical study for its PA5108 Ocular Implant in subjects with mild to moderate glaucoma. The ocular implant is designed to deliver 6 months of latanoprost and to biodegrade, allowing for repeat dosing. In the initial cohort, PA5108 showed a >20% reduction in IOP at 12 weeks and 26 weeks. In a further cohort, the implant’s rapid biodegradation profile allowed for eight patients to receive a second implant at 21 weeks, providing ongoing, uninterrupted therapy with no product-related adverse effects. The implant is the first biodegradable ocular implant in development that has the potential to be used safely for repeat dosing, the company says. PolyActiva plans to initiate its Phase 2b clinical trial in the United States, Australia and New Zealand in 2024.

• Amydis Inc. launched a Phase 2 clinical program for its novel patented retinal tracer, AMDX-2011P, to detect amyloid-beta in glaucoma patients. AMDX-2011P is a small molecule designed to enable detection and quantification of amyloid beta deposits in the retina using imaging devices already incorporated as part of a patient’s standard office visit. The Amydis test will increase the capture rate of glaucoma while improving clinical management through earlier intervention and, potentially, facilitation of amyloid beta targeted neuroprotective therapies. In collaboration with the University of California-San Diego, Amydis completed critical proof-of-concept studies demonstrating the Amydis tracers detect amyloid beta in post-mortem human eyes of glaucoma patients, but not healthy subjects. The results have been submitted for publication. Amydis has launched a Phase 2 open label, blinded endpoint assessment study of AMDX-2011P as a retinal tracer in subjects with primary open angle glaucoma.

• Ocular Therapeutix received written agreement regarding the overall design from the FDA under a Special Protocol Assessment (SPA) for the company’s ongoing pivotal Phase 3 clinical trial for AXPAXLI (axitinib intravitreal implant),for the treatment of wet AMD (the SOL trial). The company initiated the SOL trial in September and expects to enroll approximately 300 evaluable wet AMD subjects who are treatment naïve in the study eye in the trial. The SOL trial is designed to be a multi-center, parallel-group trial run primarily at US sites, with subjects randomized to one injection of aflibercept or one implant of AXPAXLI followed by supplemental anti-VEGF treatment based on pre-specified criteria. With the agreement under the SPA, the company will begin enrolling patients in the SOL trial and expects to dose the first subject by year-end.

• Eyenovia Inc. announced the FDA approved Eyenovia’s supplemental new drug application, adding Coastline International as a contract manufacturer. Coastline will manufacture cartridge subassemblies for Mydcombi, the FDA-approved tropicamide and phenylephrine hydrochloride fixed combination for mydriasis. The company says it anticipates having product available to ship in January 2024. 

• Verana Health and the Foundation Fighting Blindness announced a partnership focused on providing the life sciences community with deeper and broader data to optimize and expedite clinical trials. Under the partnership, the Foundation will provide Verana with de-identified genomics data from its My Retina Tracker Registry to support clinical research surrounding patients with inherited retinal degenerative diseases. This partnership leverages the Foundation’s de-identified genomics and patient-reported data on thousands of individuals with inherited retinal degenerative diseases to support commercial real-world evidence clinical research initiatives. Through its partnership with the Foundation, Verana will be able to incorporate the Foundation’s detailed genomics and patient-reported data, along with IRIS Registry data, into its client-facing clinical research initiatives. Specific research applications for the combined dataset include patient and site selection for clinical trials, health economics and outcomes research, medical affairs support and more.

• Researchers at the University of Tennessee Health Science Center found that one in three children with sickle cell disease had retinopathy, of which 9% required treatment, suggesting children need to be screened for vision problems as often as adults with sickle cell disease. The researchers also evaluated the effectiveness of different therapies for sickle cell disease and found that hydroxyurea and chronic transfusions were associated with decreased rates of retinopathy, even when accounting for different genotypes. To conduct the study, the researchers evaluated records for 652 patients, aged 10 to 25 years (median age: 14) who underwent eye exams (2,240 visits) over a 12-year period. They found that 33% had nonproliferative retinopathy; 6% had proliferative retinopathy (PR); and 33 eyes were treated with panretinal photocoagulation, most commonly for PR stage 3 (43%). Intravitreal anti-VEGF therapy was given to five eyes, all with PR. 

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.