• Bausch + Lomb entered into a definitive agreement with Novartis under which Bausch + Lomb will acquire XIIDRA (lifitegrast ophthalmic solution) 5%, a non-steroid eyedrop specifically approved to treat the signs and symptoms of dry eye disease (DED) focusing on inflammation associated with dry eye. The acquisition will complement Bausch + Lomb’s existing dry eye portfolio, which includes MIEBO (perfluorohexyloctane ophthalmic solution). As part of the transaction, Bausch + Lomb will also acquire libvatrep (also known as SAF312), an investigational compound in Phase 2b development being studied for the treatment of chronic ocular surface pain, and AcuStream technology, an investigational device that may have the potential to facilitate precise dosing and accurate delivery of certain topical ophthalmic medications to the eye. 

• The FDA issued a Complete Response Letter (CRL) for Regeneron Pharmaceuticals’ Biologics License Application for aflibercept 8 mg for the treatment of patients with wet AMD, diabetic macular edema (DME) and diabetic retinopathy, due to an ongoing review of inspection findings at a third-party filler. The CRL did not identify any issues with the aflibercept 8 mg clinical efficacy or safety, trial design, labeling or drug substance manufacturing, and no additional clinical data or trials have been requested. Regeneron also announced top-line, 2-year data for aflibercept 8 mg from the pivotal PHOTON trial in patients with DME. Aflibercept 8 mg patients were initially randomized to either 12- or 16-week dosing intervals and were able to shorten or extend dosing intervals if pre-specified criteria were met. The longer-term data among patients who completed the trial demonstrated that the vast majority of patients were able to maintain or further extend these dosing intervals through 2 years. For more, see the study results here.

• Bruder Healthcare announced an eye-care industry distribution agreement with AllerFocus for its Percutaneous Allergy Test, pain-free, needle-free allergy screening for 78 of the most common airborne and environmental allergens. Included in the kit that doctors will receive is a supply of the 78 allergens (shipped cold), dip well tray sets and storage containers, 10-prong sterile testing applicators, a measurement tool, documents (including an allergy health assessment form, test prep card for patients, test signature forms, and a color-coded test report form), plus marketing materials in English and Spanish. An allergen description book and allergen test cart are also shipped in the first delivery to doctors. Each kit contains enough testing materials for 40 patients.

• Leiters is rebranding the company, which includes a company name change to Leiters Health, a new corporate logo and a new partnership statement, Quality Compounding for Life. The new brand for Leiters Health reinforces its alignment with the health-care industry it serves and reflects its commitment and support of health-care professionals and their patients, the company says. Leiters Health now provides an end-to-end product offering including pre-filled syringes, IV bags and vials, non-opioid pain solutions, and ophthalmic medications and services, including FDA-compliant repackaged Avastin.

• Doheny Eye Institute announced that SriniVas R. Sadda, MD, was named president elect of ARVO. In his role as president elect, Dr. Sadda will continue to serve on the board as well as begin planning for his term as president, which will kick off next May at the conclusion of ARVO’s 2024 annual meeting. Dr. Sadda is the director of Artificial Intelligence & Imaging Research at Doheny Eye Institute and professor of ophthalmology at the University of California – Los Angeles (UCLA) David Geffen School of Medicine. 

• In an effort to educate the public on dry eye, Prevent Blindness has declared July as “Dry Eye Awareness Month.” Information is available on dry eye risk factors, symptoms and treatment options through a variety of resources, including fact sheets and shareable social media graphics (available in English and Spanish) and a dedicated web page. In addition, Prevent Blindness is offering a new episode of the Focus on Eye Health Expert Series, “Dry Eye and Meibomian Gland Dysfunction (MGD),” featuring April Jasper, OD, FAAO, Advanced Eyecare Specialists, West Palm Beach, Fla. In the video, Dr. Jasper shares her experience as a dry eye patient as well as an eye-care provider and discusses ways that dry eye can effectively be treated. For the third consecutive year, OCuSOFT Inc. is partnering with Prevent Blindness in support of Dry Eye Awareness Month.

• Bausch + Lomb will kick off a new social media campaign designed to increase the understanding of DED and the role of tear evaporation as a leading driver of the disease. The campaign, which will run throughout July during National Dry Eye Awareness Month, is designed to educate eye-care professionals and consumers about DED and foster physician-patient dialogue. Throughout July, Bausch + Lomb will post educational content and resources on its social media pages, including information on how people with DED are significantly more likely to report problems with performing everyday activities, such as reading, using a computer, watching television and driving. Visit www.alleyesonevaporation.com for additional educational insights on DED.

• Oculis will host its first R&D Day featuring multiple experts to showcase its clinical programs targeting retina diseases on July 11, 2023, from 10 a.m to noon EST at the Lotte New York Palace Hotel. Topics to be covered by retina specialists and the Oculis management team include the unmet medical needs and current treatment landscapes in DME, cystoid macular edema (CME) and acute optic neuritis (AON). In addition, updates will be provided on the OCS-01 DME DIAMOND program (the recent Stage 1 read-out of the DIAMOND trial and plans for the upcoming DIAMOND 1 and DIAMOND 2 trials), OCS-01 CME LEOPARD trial (the PoC LEOPARD trial initiation of OCS-01 eyedrops in CME) and OCS-05 AON ACUITY trial (the ongoing PoC ACUITY trial of OCS-05, a neuroprotective candidate with a novel mechanism of action, in AON). To register for the event, click here.

• Aldeyra Therapeutics announced positive top-line results from the Phase 2 clinical trial of intravitreal ADX-2191 (methotrexate injection, USP), an investigational drug candidate, in patients with retinitis pigmentosa. Relative to baseline, the clinical trial demonstrated statistically significant improvement in retinal function across a number of different physiological and psychophysical assessments. The primary endpoint of the clinical trial was safety. Relative to baseline, across all patients, statistical significance was achieved for improvement in BCVA (P<0.0001), low-light visual acuity (P=0.0001), time to electroretinographic response to light (P=0.02), macular sensitivity to light (P<0.0001) and dark-adapted peripheral sensitivity to light (P<0.0001). ADX‑2191 was well tolerated, and no safety concerns were identified.

• iOR Partners announced the publication of “Safety of Office-Based Lens Surgery: A U.S. Multicenter Study,” in the Journal of Cataract & Refractive Surgery. The study evaluated case records of more than 18,000 consecutive patients who underwent office-based lens surgery for visually significant cataract, refractive lens exchange or phakic IOL implantation at 36 participating US sites. The study results showed that office-based lens surgery can be performed safely, with adverse event rates similar to or lower than those in the published literature. Outcome measures included the assessment of intra- and postoperative complications. While many of the cases in the study were younger patients undergoing refractive lens exchange, 54% were Medicare-age and the majority had comorbidities typical of any cataract surgery population. For more, see the study results here.

• Elios Vision announced it completed enrollment for its pivotal trial of more than 300 patients with mild to moderate glaucoma treated with the ELIOS procedure in combination with cataract surgery. ELIOS is an implant-free procedure that uses next generation excimer laser technology for the treatment of glaucoma.

• EyeCare Partners (ECP) launched a new Advanced Comprehensive Ophthalmology Fellowship (ACOF), aimed at enhancing the training and expertise of aspiring ophthalmologists while also increasing access to quality eye care for patients. ACOF is a one-year program that will provide comprehensive training to residency graduates in the latest advancements in ophthalmology, including diagnostic and therapeutic techniques, surgical procedures and clinical research. The fellowship program starts in fall 2024 and will be sponsored by three ophthalmologists, who will provide hands-on training and mentorship to fellows in a supportive and collaborative environment. Fellows will also have access to facilities and equipment to enhance their learning experience. Successful fellows will be offered opportunities to join ECP practices and participate in a career-long mentorship program. Applications for ACOF are now open (www.eyecare-partners.com/acof/) with an application deadline for 2024 fellowships of Aug. 31, 2023.

• A Northwestern Medicine study has uncovered novel cellular mechanisms within the retina, findings that could help advance the development of targeted therapeutics for diseases and conditions impacting vision, according to findings published in Nature Communications. Investigators showed that certain bipolar cell types respond to individual fusion events and total quanta, while other types respond to degrees of locally coincident events, creating a nonlinear summation. These differences are caused by a combination of factors specific to each bipolar cell type, including diffusion distance, contact number, receptor affinity and proximity to transporters. For more, see the study results here.

• Visgenx Inc. announced positive data from a non-human primate study. The study used a single subretinal injection to deliver VGX-0111 (carrying an ELOVL2 transgene) to investigate whether VGX-0111 expresses in the target tissues and causes an increase in certain very long chain polyunsaturated fatty acids at a dose that is well tolerated. VGX-0111 demonstrated good tolerability, provided strong transgene expression in the targeted region of the retina and increased production of the lipids whose decline is associated with macular degeneration. The company is moving the development program forward with the intention of conducting a human proof of concept study. 

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.