Study: large-scale MIGS study

Sight Sciences announced the presentation of a large-scale MIGS study that included more than 100,000 eyes with glaucoma and evaluated three commonly used MIGS procedures performed with cataract surgery compared to cataract surgery alone. According to the company’s press release, the study used data from the American Academy of Ophthalmology’s IRIS Registry and included data that showed 2-year outcomes after use of the OMNI Surgical System for “Trabeculocanalicular Outflow Restoration” (Sight Sciences), the Hydrus Microstent (Alcon), and the iStent inject (Glaukos). The company stated that 9,000 eyes received a MIGS procedure in combination with cataract surgery; 100,745 eyes received cataract surgery alone. Eyes were divided into two groups—those with a baseline IOP of more than 18 mm Hg (Group 1) or 18 mm Hg or less (Group 2). The OMNI Group 1 showed a mean IOP of 22.5 mm Hg 2 years postop on 1.95 IOP-lowering medications; Group 2 had a mean IOP of 14.1 mm Hg on 2.01 medications. The Hydrus Group 1 had a mean IOP of 22.5 mm Hg on 1.89 medications, and Group 2 was 14.2 mm Hg on 1.89 medications. The iStent Group 1 had a mean of 22.2 mm Hg postop on 1.58 medications, and Group 2 was 14.4 mm Hg on 1.58 medications. Finally, eyes that had cataract surgery alone had a mean 22.8 mm Hg on 1.6 medications in Group 1, while Group 2 had a mean IOP of 14.5 mm Hg on 1.62 medications. The company reported that at 24 months postop, patients with the highest baseline IOP (Group 1) who had the OMNI Surgical System showed the “greatest numerical reduction in IOP and the greatest numerical reduction in medication use.” Patients who had a low baseline IOP (Group 2) also had a greater numerical reduction in IOP with OMNI as well as a statistically significant greater mean reduction in IOP-lowering medications, according to the company.

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Partnership to advance early disease detection

Carl Zeiss Meditec and Boehringer Ingelheim announced a long-term strategic collaboration that will develop predictive analytics for the early detection of eye diseases and identify personalized treatments to prevent vision loss. According to the company’s press release, this partnership will identify markers of early-stage retinal diseases using the cloud-connected devices and AI technology and lead to the development of personalized precision therapies to prevent vision loss.

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License agreement to move forward option for cataract surgery sedation

Melt Pharmaceuticals announced that it entered into a development and license agreement with Catalent for MELT-300, a sublingual, needle-free and opioid-free sedation option that the company is developing for cataract surgery. According to the company’s press release, the agreement will allow Melt to use Catalent’s Zydis orally disintegrating tablet technology with its MELT-300 formulation of midazolam 3 mg and ketamine 50 mg. Melt previously announced that it had achieved its procedural sedation endpoint in the Phase 2 efficacy and safety study. It is in discussion with the FDA for its Phase 3 program, which it noted is expected to begin in 2024.

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Name change news

Harrow Health, Inc. has completed its transition to have the corporate name of Harrow, Inc. According to the company’s press release, this change is in alignment with a 5-year strategic plan that includes an exclusive focus of the company on eyecare pharmaceuticals.

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ASCRS news and events

• ASCRS Annual Meeting: The call for submissions for the 2024 ASCRS Annual Meeting ends Monday, October 9 at 11:59 p.m. ET. Find submission details here.
• ASCRS Live Webinar: “Complex Presbyopia IOLs,” a live educational event, will take place Tuesday, October 24 at 9:00 p.m. ET. Register now for this webinar.
• A Taste of ASCRS: This nine-section CME program recorded from the 2023 ASCRS Summer Meeting is now available on demand. Learn more about the program.

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Research highlights

• A prospective case series published in the Journal of Cataract & Refractive Surgery sought to demonstrate the safety and efficacy of allogenic corneal inlays to increase depth of focus in eyes with presbyopia. The study included 50 eyes of 25 patients with 3 years of follow-up. The patients had presbyopia, and the inlay was implanted in the non-dominant eye. According to the authors, there was no significant difference in UDVA and CDVA between the eye with the inlay and the eye without it, though there was a 1-line decrease in CDVA preop to postop in 24% of patients. UNVA was significantly better in the eye with the inlay. The authors reported a mean depth of focus of 2.8 D in the treated eye and binocularly; mean depth of focus in the untreated eye was 1.1 D. The investigators concluded that allogenic inlays provided a clinically and statistically significant increase in depth of focus.
• A point-of-care diagnostic test for Aspergillus in cases of microbial keratitis (MK) was evaluated as a minimally invasive option needed in low- and middle-income countries. According to the paper published in JAMA Ophthalmology, the Aspergillus-specific lateral-flow device (AspLFD) was used in a study conducted from May 2022–January 2023 at the Aravind Eye Hospital in Madurai, India. The study included 198 participants. Thirty-five of 198 with corneal scrape and 17 of 40 with swab samples had positive culture results for Aspergillus species. The AspLFD showed high diagnostic accuracy in identifying Aspergillus species from both scrapes and swabs. The authors described this test as “an important step toward the provision of point-of-care diagnostics for MK.”

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Product news

• Bausch + Lomb completed its acquisition of Xiidra (lifitegrast ophthalmic solution) from Novartis. As part of the transaction, it also acquired libvatrep (SAF312), a compound being investigated for treatment of chronic ocular surface pain, and AcuStream, an investigational device for topical ophthalmic medication dosing.

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