• Ocuphire Pharma announced the initiation of the VEGA-2 Phase 3 pivotal trial with the first patient enrolled in late December. VEGA-2 is a randomized, double-masked, placebo-controlled, multi-center study to evaluate Nyxol (phentolamine ophthalmic solution 0.75%) as a single agent and with adjunctive low-dose pilocarpine 0.4% in 320 subjects with presbyopia. The study will be conducted in two stages. In addition to the VEGA-2 trial, Ocuphire plans to initiate a second Phase 3 pivotal trial in presbyopia (VEGA-3) and a one-year safety study (LYRA-1) in 2023.

• Bausch + Lomb announced the US introduction of PreserVision AREDS 2 Formula mini soft gels with OCUSorb. Offering a proprietary composition of lutein and zeaxanthin, OCUSorb has been clinically shown to provide superior absorption of these nutrients into the body. PreserVision AREDS 2 Formula eye vitamins, including the new OCUSorb formula, contain the exact nutrient formula recommended by the National Eye Institute. This exact formula includes certain amounts of lutein and zeaxanthin, two important antioxidants that have been clinically shown to help reduce the risk of AMD progression.

• Bausch + Lomb and Novaliq announced that Ophthalmology published results from the pivotal Phase 3 trial GOBI, one of two pivotal Phase 3 trials for NOV03 (perfluorohexyloctane). NOV03 is being investigated to treat the signs and symptoms of dry eye disease (DED) associated with meibomian gland dysfunction. At Week 8, change from baseline in total corneal fluorescein staining was statistically significantly greater in the NOV03 arm compared to the control saline group (least-squares [LS] mean treatment difference, -0.97; (95% confidence interval [CI]: -1.40 vs -0.55) (P<0.001)). At Week 8, eye dryness VAS score was statistically significantly improved in the NOV03 arm compared to control group (LS mean treatment difference, -7.6; (95% CI: -11.8 vs -3.4) (P<0.001). For more, see the study results here.

• FCI Ophthalmics announced the US availability of EZYPOR, a high-density polyethylene orbital implant for enucleation, evisceration and secondary implantation. The implant comes with a smooth anterior suturing platform with eight suture tunnels, allowing for multiple suturing options. EZYPOR is made of ultra-high-molecular-weight polyethylene and has a porosity between 40 and 60% for optimum colonization of fibrovascular tissues. Additionally, an autologous graft is not needed with the use of this orbital implant.

• Glaukos Corp. announced positive clinical updates for several of its Corneal Health pipeline programs, including the commencement of subject enrollment in a second Phase 3 confirmatory trial for Epioxa (Epi-on), its next-generation corneal cross-linking therapy for the treatment of keratoconus, and promising initial results from the company’s Phase 2a clinical trial for GLK-301 (iLution), a sterile ophthalmic topical cream for DED. Topline Phase 2a outcomes for GLK-301 demonstrated improvement in the quality of tear film with corresponding improvement in quality of vision. Additionally, Glaukos reported positive results for a clinical trial designed to evaluate the safety of the surgical exchange procedure for iDose TR (travoprost intraocular implant) in subjects who had previously been administered an iDose TR in the Phase 2b clinical trial (exchange trial). Results demonstrated a second administration of iDose TR and removal of the original iDose TR implant was safe and well-tolerated, with the second iDose TR showing a favorable safety profile over a 12-month evaluation period.

• Viatris Inc. closed its acquisitions of Oyster Point Pharma and Famy Life Sciences to establish a new Viatris Eye Care Division. The new division combines Oyster Point Pharma's eye-care expertise with Famy Life Science's Phase 3-ready pipeline. Former Oyster Point Pharma CEO, Jeffrey Nau, PhD, MMS, will lead the new division. Under the terms of a definitive agreement, Viatris acquired Oyster Point Pharma for approximately $415 million in cash upfront. The aggregate acquisition price for the Famy Life Sciences business is expected to be approximately $280 million.

• Acelyrin Inc. acquired ValenzaBio in an all-stock transaction. The acquisition adds multiple clinical and pre-clinical development programs to Acelyrin’s immunology pipeline, which is led by izokibep, a small therapeutic protein inhibitor of interleukin-17A (IL-17A). The additional assets added to the Acelyrin portfolio now include: Lonigutamab (VB-421), a subcutaneously delivered anti-IGF-1R currently being evaluated in a Phase 1 study for thyroid eye disease with potential implications for efficacy, safety and administration benefits for patients; and VB-517, a pre-IND anti-c-KIT being studied as a treatment option in Chronic Urticaria.

• Amber Ophthalmics released positive topline results from the Phase 2 randomized, double-masked, vehicle-controlled clinical trial (EXPEDE) evaluating two topically administered concentrations of NEXAGON (lufepirsen ophthalmic gel) for the treatment of persistent corneal epithelial defect (PCED), secondary to chemical and/or thermal injury. When the primary endpoint was assessed, both NEXAGON high (n=12) and low dose (n=12) treatment groups achieved 66.7% corneal epithelial recovery, as compared to 27.3% of those receiving vehicle (n=11), a clinically meaningful difference of 39.4% (Fisher's exact test: p=0.065). NEXAGON has been granted orphan drug designation by the FDA for the indication of PCED.

• Eyenovia Inc. reported positive results from a research study conducted in collaboration with Dr. Pedram Hamrah, interim chairman of ophthalmology at Tufts Medical Center, which evaluated the gene and protein expression of cytokines and chemokines after latanoprost+benzalkonium chloride (BAK) treatment administered via Optejet vs latanoprost+BAK administered via standard eyedrops. The study found that the expression of pro-inflammatory cytokines and chemokines was decreased in two out of three cytokines with the latanoprost+BAK treatment administered via Optejet compared to latanoprost+BAK administered via standard drops. These findings demonstrated Optejet’s ability to reduce inflammatory processes and pathways.

• Pixium Vision announced that the second generation of implants for its bionic vision system PRIMA for atrophic AMD could restore vision at five times higher resolution than the current PRIMA implants. A recent peer-reviewed paper published in Nature Communications, outlined results from the testing of the new implant in rats. This demonstrated a high-resolution prosthetic vision based on a novel design of a photovoltaic array, where field confinement is achieved by dynamic current steering, and computational modeling of the field confinement in such an optically controlled circuit validated by in vitro and in vivo measurements. For more, see the study results here.
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• Olleyes Inc. earned the International Organization for Standardization (ISO) 13485:2016 certification from SGS. The certification demonstrates the company's compliance with medical device quality management system requirements under the Medical Device Single Audit Program (MDSAP). ISO/MDSAP certifications emphasize a key achievement in the international expansion for Olleyes' FDA-cleared VisuALL VRP, a device that leverages virtual reality, artificial intelligence and dynamic matrix eye tracking to enable eye-care providers to test their entire patient base comfortably and efficiently.

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.