Sustained-release IOP-lowering implant approved

Glaukos announced FDA approval of iDose TR (travoprost intracameral implant) 75 mcg for IOP lowering in patients with ocular hypertension or open-angle glaucoma. According to the company’s press release, this approval was based on two pivotal Phase 3 studies that included more than 1,150 participants across 89 clinical sites. The company stated that both trials achieved primary efficacy endpoints through 3 months and demonstrated tolerability and safety over 12 months. IOP reduction from baseline to 3 months was 6.6–8.4 mm Hg in the iDose TR arm compared to 6.5–7.7 mm Hg in the control arm (timolol 0.5% dosed BID topically), according to the press release. With these findings, iDose TR demonstrated non-inferiority to timolol ophthalmic solution. The company’s press release reported that iDose TR did not demonstrate non-inferiority over the additional 9 months. Glaukos described iDose TR as a “first-of-its kind, long-duration, intracameral procedural pharmaceutical therapy designed to continuously deliver 24/7 therapeutic levels of a proprietary formulation of travoprost inside the eye for extended periods of time.”

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Positive topline results in Phase 2a trial for treatment of MGD in patients with Demodex

Tarsus Pharmaceuticals announced positive topline results from its Phase 2a clinical trial evaluating TP-03 (lotilaner ophthalmic solution, 0.25%) for treatment of MGD in patients with Demodex. According to the company’s press release, the treatment administered two or three times daily for 12 weeks resulted in an increased amount and quality of lipid secretions from meibomian glands, measured by the Meibomian Gland Secretion Score. More specifically, there was an increase of 10.5 and 11.7 at BID and TID, respectively, compared to baseline. The number of glands secreting increased to 4.8 and 5.3 glands BID and TID, respectively, from baseline. Both were significant and clinically meaningful increases compared to baseline. The company reported that there were not statistically significant differences between the BID and TID arms.

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First patient visit in Phase 2b trial evaluating anti-TNFα for dry eye disease

Oculis announced that it has had its first patient visit in its Phase 2b trial for anti-TNFα for treatment of inflammatory dry eye disease. According to the company’s press release, this multi-center, double-masked, vehicle controlled randomized trial is evaluating licaminlimab (OCS-02), a biologic drop, in moderate to severe dry eye disease. It is also seeing whether patients with a specific genetic biomarker might respond better to the treatment. The study will randomize 120 participants for a 6-week licaminlimab or vehicle treatment with 2-week follow up. Topline results are expected mid-2024.

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Smart contact lens makes progress

Azalea Vision reported that its ALMA Lens, the company’s first prototype of a smart contact lens platform, has been used on a human eye. The ALMA Lens is designed to be a non-surgical solution for keratoconus, corneal irregularities, photophobia, and presbyopia. According to the company’s press release, this lens includes an embedded diaphragm whose aperture can be modulated. It also includes a microchip, RF antenna, medical-grade micro-battery, and configurable light control. Its first application will be treating irregular astigmatism due to keratoconus.

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Asset transition

Théa completed its transaction to acquire two late-stage ophthalmic assets from ProQR Therapeutics. It acquired sepofarsen and ultevursen and will continue their development for possible treatments for Leber congenital amaurosis and Usher syndrome.

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ASCRS news and events

• ASCRS Annual Meeting: Registration for the 2024 ASCRS Subspecialty Day and ASCRS Annual Meeting is now open. Learn more about this premier educational and networking event for anterior segment surgery here.
• A Taste of ASCRS: This nine-section CME program is available on demand. Learn more about the program.
• ASCRS Podcast: Episode 5 of Ophthalmology Quicksand Chronicles—Eureka Moments! is available now. Find it here.

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Research highlights

• A study published in the laboratory science section of the Journal of Cataract & Refractive Surgery sought to assess whether IOL implantation induces a shift in the peripheral visual field. The ray-tracing study involved “nonsequential ray-tracing simulations” that were performed on an eye model with phakic and pseudophakic visions. According to the authors, the two designs were tested at five different axial positions and seven different powers. The relation between the position of the light source and location of where the model retina was illuminated were used to calculate visual field shifts. The authors found that there was a less than 1 degree shift in central vision in all models, but in peripheral vision, there was a central shift. The magnitude of this shift was dependent on the IOL design and axial position. The authors reported that it could be as high as 5.4 degrees toward central vision. They concluded that “such a shift can affect the perception of peripheral visual complaints.”
• The visual impairment burden among working-age individuals (15–64 years old) from 1990 to 2019 was examined in a cross-sectional study that spanned more than 200 countries and territories, published in JAMA Ophthalmology. The study found more than 437 million individuals living with visual impairment in 2019, which was a 91.46% increase of cases since 1990. The authors noted a “mild decrease” in visual impairment in less developed countries but an increase in countries considered to be high and high-middle on the sociodemographic index. The authors advocated for gaining a better understanding of the epidemiology behind this increase in order to develop prevention and treatment options for medical and social reasons.

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Product news

• BELKIN Vision has received FDA 510(k) clearance for its glaucoma laser, the Eagle, which is intended to perform SLT.
• Ophtec announced the European launch of its Precizon Go IOL for enhanced intermediate vision. This IOL received the CE Mark earlier this year.

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