• Tarsus Pharmaceuticals announced the FDA approved XDEMVY (lotilaner ophthalmic solution) 0.25% for the treatment of Demodex blepharitis. XDEMVY, formerly known as TP-03, is the first FDA-approved treatment to directly target Demodex mites, the root cause of Demodex blepharitis. XDEMVY is expected to be available by prescription by the end of August 2023. The FDA approval is based on results from two randomized, multicenter, double-masked, vehicle-controlled studies (Saturn-1 and Saturn-2), designed to evaluate the safety and efficacy of XDEMVY in 833 patients, 415 of which received XDEMVY. Efficacy was demonstrated by a significant improvement in eyelids (reduction of collarettes, the pathognomonic sign of the disease, to no more than two collarettes per upper lid) in each study by Day 43, with some patients seeing improvement as early as 2 weeks. 

• Opthea Limited announced the American Medical Association’s United States Adopted Names Council, in consultation with the World Health Organization’s International Nonproprietary Names Expert Committee, approved and adopted the nonproprietary drug name “sozinibercept” for the company’s lead biologic drug candidate, OPT-302. Sozinibercept (OPT-302) is the company’s novel recombinant “trap” fusion protein targeting inhibition of vascular endothelial growth factors C and D (VEGF-C and VEGF-C), two ligand mediators of angiogenesis and vascular leakage involved in retinal vascular diseases. Sozinibercept administered by intravitreal injection in combination with standard of care anti-VEGF-A therapy is currently being evaluated in two Phase 3 clinical trials for the treatment of wet AMD, for which it holds Fast Track designation from the FDA. Sozinibercept is proprietary to Opthea with issued patents running to at least 2034 and currently pending patents that are expected to extend coverage. 

• RetinAI Medical AG and Retina Consultants of America (RCA) announced a strategic partnership to develop an extensive and AI-insight driven Real World Evidence (RWE) US-based database in ophthalmology. This partnership will leverage RetinAI's digital health technologies and RCA's network of clinics to analyze real-world health clinical and imaging data. The result will be a comprehensive resource that provides valuable insights into health outcomes, medication adherence and the effectiveness of various treatment protocols. The companies will invest in efforts to provide licensed access to the RWE data in Q4 2023 to stakeholders interested in analysis, research and clinical study design for optimizing patient care. RCA and RetinAI will generate RWE in retinal diseases such as AMD (including intermediate AMD, geographic atrophy and neovascular AMD), diabetic macular edema (DME) and diabetic retinopathy, and expand to areas of cardiovascular and neurodegenerative diseases where retinal imaging plays a role in identifying disease.

• EyePoint Pharmaceuticals announced interim masked safety data and baseline patient demographics from its Phase 2 DAVIO 2 clinical trial of EYP-1901, a potential sustained delivery maintenance treatment for wet AMD. A masked safety summary found that there have been no reported drug-related ocular serious adverse events (SAEs) and no reported drug-related systemic SAEs in the DAVIO 2 trial as of July 1, 2023. There were two ocular SAEs unrelated to EYP-1901 in the trial: Retinal detachment in a study eye detected at week 1 (1 week post initial aflibercept injection, prior to EYP-1901 injection); and retinal hemorrhage in a non-study fellow eye. EyePoint also presented the Phase 2 DAVIO 2 trial screening characteristics and provided a comparison to baseline demographics of the Phase 1 DAVIO patients. Interim baseline data on patients in the Phase 2 DAVIO 2 trial as of July 1, 2023, reveal that patients feature a mean BCVA of 74 letters, compared with a mean BCVA of 69 letters in the Phase 1 DAVIO trial. For more, click here. 

• Verséa Ophthalmics, a division of Verséa Health, announced the commencement of initial shipments of its tear-based point-of-care (T-POC) TOTAL IgE (Immunoglobulin E) Immunoassay and Lateral Flow Readers. The T-POC TOTAL IgE Immunoassay Kit is a new quantitative point-of-care test used in the diagnosis and management of patients suffering from ocular surface disease. The T-POC TOTAL IgE test measures the levels of IgE, providing a numerical value that enables clinicians to differentially diagnose a patient’s condition and to inform the prescribing decision. Verséa plans to follow in the next few weeks with the shipment of T-POC LACTOFERRIN, a test for aqueous deficient dry eye disease (DED), which can be performed on the same digital reader platform. Verséa partners with AXIM Biotechnologies to manage inventory of T-POC products. In addition, the company plans to build upon its T-POC Quantitative Testing Platform with additional biomarkers and announced an upcoming product that will be introduced, T-POC LACTOFERRIN. Lactoferrin is a key biomarker that can help distinguish aqueous deficient DED from evaporative DED. In addition, Verséa and Celularity Inc. entered into an exclusive US commercialization agreement in which Verséa will distribute Celularity’s BIOVANCE and BIOVANCE 3L Ocular products to support the treatment of ocular surface disease (OSD) and ocular surgical applications. BIOVANCE and BIOVANCE 3L Ocular, which are single-layer and three-layer (3L) allografts, respectively, are intended for use as a biological membrane covering that provides an extracellular matrix. 

• Kodiak Sciences is discontinuing further development of tarcocimab tedromer, a novel antibody biopolymer conjugate, that was being studied as a potential treatment for wet AMD and DME. While its Phase 3 DAYLIGHT study for the treatment of wet AMD met the primary endpoint of non-inferior visual acuity gains for tarcocimab dosed monthly compared to aflibercept dosed every 8 weeks following 3 monthly loading doses, the decision to discontinue development was based on the Phase 3 trial data from the company’s GLEAM and GLIMMER studies for the treatment of DME. Both GLEAM and GLIMMER studies did not meet their primary efficacy endpoints of showing non-inferior visual acuity gains for tarcocimab dosed every 8 to 24 weeks after 3 monthly loading doses compared to aflibercept given every 8 weeks after 5 monthly loading doses. An unexpected increase in cataracts was observed over time in the tarcocimab arms of both GLEAM and GLIMMER. For more, see the study results here.

• Investigators from Cedars-Sinai provided new understanding of how diabetes delays wound healing in the eye, identifying for the first time two related disease-associated changes to the cornea. The findings, published in Diabetologia, also identified three therapeutic pathways that reversed these changes and partially restored wound-healing function to the cornea — a discovery that could ultimately inform new treatments for diabetes. The new research also identifies for the first time an important role of Wnt-5a, a secreted signaling protein investigators found responsible for corneal wound healing and the function of stem cells. All three therapeutic methods, in the diabetic samples, stimulated stem cell marker production and improved tissue regeneration, accelerating wound healing. For more, click 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.