• Glaukos Corp. submitted a new drug application (NDA) to the FDA for iDose TR. iDose TR is a micro-invasive intraocular implant designed to continuously deliver therapeutic levels of a proprietary formulation of travoprost from within the eye for extended periods of time. Travoprost is a prostaglandin analog used to lower IOP. iDose TR is intended to address ubiquitous patient non-compliance and chronic side effects associated with topical glaucoma medications.

• Aldeyra Therapeutics announced the FDA accepted for Priority Review the NDA for ADX-2191 (methotrexate injection, USP), an investigational drug candidate for the treatment of primary vitreoretinal lymphoma. The FDA assigned a Prescription Drug User Fee Act date of June 21, 2023. The company also reported top-line results from a 12-month, vehicle-controlled, multicenter, parallel-group safety clinical trial of reproxalap, an investigational new drug, in dry eye disease patients. The primary endpoints of treatment-related serious adverse events in ocular safety were not observed in any patient. In a post-hoc analysis, reproxalap was statistically superior to vehicle in improvement from baseline in distance visual acuity. Visual acuity improved over 12 months in both treatment groups, and improvement in patients treated with reproxalap was statistically superior (P=0.018) to that in patients treated with vehicle.

• AbbVie and Capsida Biotherapeutics announced an expanded strategic collaboration to develop genetic medicines for eye diseases with high unmet need. AbbVie's capabilities will be paired with Capsida's novel adeno-associated virus (AAV) engineering platform and manufacturing capability to identify and advance three programs. The collaboration builds upon the neurodegenerative disease partnership announced in 2021. Capsida will lead capsid discovery efforts for all programs using its AAV engineering platform and will be responsible for process development and early clinical manufacturing. AbbVie will lead innovative therapeutic cargo approaches and be responsible for development and commercialization.

• EyePoint Pharmaceuticals and Rallybio Corp. announced a research collaboration that will evaluate sustained delivery of Rallybio’s inhibitor of complement component 5 (C5) using EyePoint’s proprietary Durasert technology for sustained intraocular drug delivery. The initial focus will be on geographic atrophy (GA). Under the terms of the research collaboration, EyePoint and Rallybio will collaborate to explore and assess the viability of utilizing Rallybio’s C5 inhibitor in EyePoint’s sustained release Durasert technology, with the intention to expand the collaboration upon mutual agreement following the evaluation.

• IVERIC bio announced an exploratory time-to-event analysis from the avacincaptad pegol (ACP) GATHER clinical trial program evaluating reduction in vision loss with ACP 2 mg vs sham treatment. The GATHER1 and GATHER2 clinical trials were designed to evaluate the rate of GA lesion growth in patients with GA secondary to AMD. The post-hoc analysis for vision loss from these pivotal studies signals up to a 59% reduction in rate of vision loss with ACP 2 mg compared to sham treatment at 12 months. Vision loss in this analysis was defined as a loss of ≥15 letters (EDTRS) in BCVA from baseline measured at any two consecutive visits up to month 12. 

• ViaLase Inc. announced positive results of the first-in-human study of femtosecond laser image-guided high-precision trabeculotomy (FLigHT) performed with the ViaLase technology. The results, which indicate FLigHT's potential as a safe and effective treatment option for primary open angle glaucoma, were presented at the 2023 American Glaucoma Society meeting. Investigators designed the 12-month, prospective, single-center, non-randomized study to evaluate safety and observe the IOP-lowering effect of the FLigHT treatment. During the study, investigators reported no adverse events related to FLigHT treatment and observed a reduction in mean IOP at 12 months. Additionally, 100% of eyes did not require IOP-lowering medication after 1 year, and gonioscopy revealed no evidence of scarring at the site of treatment at the same time point. A multicenter, randomized trial is currently underway to further validate the results of this first-in-human trial.

• Akorn Pharmaceuticals announced it closed all of its US sites and has laid off its workforce, effective February 23. The company has filed for chapter 7. In March 2022, Théa Pharma announced the completion of its acquisition of seven branded ophthalmic products from Akorn that included: Zioptan, Cosopt, Cosopt PF, Betimol, Azasite, Akten, and the ocular surface repair agent AcellFX. 

• Levation Pharma received FDA clearance to initiate a Phase 1/2 clinical trial of LEV102 for the treatment of acquired blepharoptosis in adults. LEV102 is a proprietary aqueous, colorless, odorless, rapidly drying gel comprised of a variety of penetration enhancers and oxymetazoline as the active pharmaceutical ingredient. The medication is applied in small quantities to the upper lid. The penetration enhancers permit transdermal permeation of the drug though the lid to reach the alpha receptors on Mueller’s muscle, inducing upper lid elevation. LEV102 is designed to function as a primer and be compatible with commercially available eye shadows.

• Compulink Healthcare Solutions delivered an updated graphical user interface (GUI) for its Advantage SMART Practice solution. Included in its Advantage 12.6 Cures Certified release, the GUI features design elements that are user friendly. Efficiency features such as panel displays and hover menus have been added throughout the software for quicker access to information and functions. Compulink’s Advantage all-in-one database solution includes specialty-specific EHR, practice management, inventory management, patient portal, patient engagement, ASC, E-Commerce, analytics, optical POS (for eye-care practices) and revenue cycle management services for its clients.

• Skye Bioscience received a positive recommendation following a pre-specified data review by the safety review committee based on dosing of the second cohort of eight healthy participants of its Phase 1 study of SBI-100 Ophthalmic Emulsion (OE). The SRC recommended that the trial continue without modification. Recruitment for the third cohort of eight participants has begun, with dosing planned in March. In the third cohort, the dose of SBI-100 OE will increase to a concentration of 2.0% (participants were administered a concentration of 1.0% in the second cohort). A description of SBI-100 OE and the Phase 1 clinical trial design can be found here.

• In an effort to help keep eyes healthy, safe and protected on the job, Prevent Blindness has declared March Workplace Eye Wellness Month. Prevent Blindness recommends eye protection that is appropriate for each job setting. To help employers educate workers on eye protection and safety, Prevent Blindness offers a Workplace Safety module as part of its free program, the Healthy Eyes Educational Series. The module includes a Presentation Guide and corresponding PowerPoint presentation. Prevent Blindness also offers a variety of workplace eye safety fact sheets and shareable social media graphics.

• An international team of researchers provided additional evidence that intracranial pressure plays an important role in normal-tension glaucoma. A recent clinical study demonstrates that low intracranial pressure correlates with impaired patient visibility, especially in the nasal zone. Eighty early-stage normal tension glaucoma (NTG) patients were enrolled in a recent study conducted by researchers from Lithuanian, Israeli and American universities. The subjects were selected from the 300 NTG patients referred to the Eye Clinic at the Lithuanian University of Health Sciences between January and October 2018. The study revealed several statistically significant correlations between intracranial pressure, translaminar pressure difference (TPD) and visual field changes. The higher the TPD, the more significant damages to the patient’s visual field were registered. The most significant visual field losses occurred in the nasal zone. For more, see the study results 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.