FDA approves new ‘full range of vision’ IOL

Bausch + Lomb announced FDA approval of its enVista Envy IOL. This IOL, according to the company, is designed to offer a full range of vision “with excellent dysphotopsia tolerance.” In a randomized controlled trial that included 332 participants, 86% of patients had little to no dysphotopsias. A separate study of 110 patients with the lens found that 94% reported “little to no difficulty” viewing objects at close range; 93% were “completely to moderately satisfied with their vision post-surgery.”

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Imaging platform designed for patients in supine position receives FDA clearance

Heidelberg Engineering received FDA clearance for its SPECTRALIS Flex Module, which the company described as ideal “for imaging the posterior segment of pediatric and adult patients in a supine position.” The Flex Module, according to the press release, mounts the SPECTRALIS onto a movable stand, offering flexibility. Like the tabletop SPECTRALIS, the company stated that the Flex Module includes high-resolution OCT, OCT angiography, fluorescein angiography, and other imaging-only modalities.

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Last patient dosed in Phase 3 study of non-IV, non-opioid sedation method

Melt Pharmaceuticals announced that the last patient has been dosed in its pivotal Phase 3 study evaluating MELT-300 (fixed dose midazolam 3 mg and ketamine 50 mg), which the company described as a non-IV, non-opioid method of sedation for cataract surgery. The Phase 3 trial is a randomized, double-blind, and three-arm study comparing a 4:1:1 ratio of MELT-300, sublingual midazolam, and sublingual placebo. It enrolled 525 patients across 13 clinical sites. A topline readout is expected by the end of 2024. A Phase 2 clinical trial showed MELT-300 to be superior in procedural sedation compared to sublingual placebo, sublingual midazolam, and sublingual ketamine.

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Phase 2 study begins to assess neuropathic corneal pain treatment

OKYO Pharma began a Phase 2 clinical trial to assess OK-101 as a possible therapy for neuropathic corneal pain. The trial is double masked, randomized, and placebo controlled, taking place over 12 weeks with an expected 48 patients whose disease is confirmed with confocal microscopy. The primary endpoint is pain relief as measured by the Visual Analog Scale. According to the company’s press release, neuropathic corneal pain does not have any commercially approved therapies. OK-101 has been shown in a prior study to significantly reduce neuropathic corneal pain in a mouse model.

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Plans to submit BLA for treatment of severe vision loss due to retinitis pigmentosa

Nanoscope Therapeutics announced that it held a meeting with the FDA for MCO-010 (sonpiretigene isteparvovec, suspension for intravitreal injection) for treatment of severe vision loss due to retinitis pigmentosa (RP) and, based on this meeting, is planning a Biologics License Application Submission within the first quarter of 2025. The company plans on a “rolling submission of the MCO-010 BLA for the treatment of severe vision loss due to RP based on its Fast Track Designation.” MCO-010 is ambient-light activatable optogenetic monotherapy that targets the inner retinal neurons. In a Phase 1/2 trial, patients who received MCO-010 showed improvement in vision-guided mobility, shape discrimination, and visual acuity. The company reported patients in a separate trial showing improvements in BCVA as well as other functional vision assessments.

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Research discovers protein related to AMD

Research, with contributions from investigators from multiple institutions, discovered a protein involved with early stages of the disease. According to a news story from the University of Rochester, the researchers used human stem cells to model AMD in animal models and found a protein, tissue inhibitor of metalloproteinases 3 (TIMP3), is overproduced in AMD. This protein, according to the article, inhibits metalloproteinases (MMPs). This impairment increases other enzymes that then contribute to inflammation and drusen formation. The researchers were able to use a small molecule inhibitor to block this activity and reduce drusen in the animal model. They suggest this could be a pathway for AMD prevention in humans.

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ASCRS news and events

• 2025 ASCRS Annual Meeting: Registration is now open for the ASCRS Annual Meeting, taking place April 25–28, in Los Angeles, California.
• ASCRS Live!: This educational dinner series is heading to several cities across the U.S. in 2024. Registration is open for the events in San Diego, California, on November 7 and Charlotte, North Carolina, on November 14.
• ASCRS Foundation: Nominations are open for the Resident Excellence Award, which awards 10 exemplary residents a travel grant, 4 nights’ accommodation, complimentary registration, and invitations to leadership and social events at the 2025 ASCRS Annual Meeting.
• ASCRS 50th anniversary: ASCRS members from the 50 states are sending in their perspectives on the Society, its impact on their career, and its influence on the specialty as a whole. Stay tuned each week through April 2025 for a new video.

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Research highlights

• The vault stability of implantable phakic contact lens 5 years postop was evaluated in a retrospective case series published in the Journal of Cataract & Refractive Surgery. The study included 140 eyes of 72 patients, 78.6% of which had a vault between 250 μm and 750 μm, 15% less than 250 μm, and 6.4% greater than 750 μm. Vault, evaluated at 1, 3, and 5 years, remained stable, according to the authors. They reported subcapsular cataracts in 2 eyes with a vault less than 250 μm, and 50 eyes (35.7%) had cysts in the sulcus (5 of these being in vaults greater than 750 μm). There were no changes in IOP or endothelial cell counts.
• The effect of amniotic membrane grafting (AMG) in the management of chemical and thermal ocular surface burns (rate of re-epithelialization and improvement in visual acuity or corneal clarity) was evaluated in a literature search published in the journal Ophthalmology. The researchers conducted a review of studies on PubMed in May 2023 and January 2024, finding four studies that were rated level II and five studies rated level III. They found that amniotic membrane grafting significantly improved corneal re-epithelialization compared to medical therapy alone in the setting of moderate burns. But for severe burns, the authors reported that amniotic membrane grafting “demonstrated no advantage over medical therapy.” It also did not have a significant advantage over medical therapy when it came to improving medical therapy or corneal therapy in moderate or severe burns.

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Product news

• Platform enhancements have been made to the Centricity Vision ZEPTOLink IOL Positioning System.

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