Positive topline results in Phase 3 clinical trial for allergic conjunctivitis treatment

Aldeyra Therapeutics announced positive topline results from its Phase 3 trial investigating reproxalap ophthalmic solution for treatment of allergic conjunctivitis. According to the company’s press release, the randomized, double-masked, vehicle-controlled, study that included use of an allergen chamber and 131 patients with allergic conjunctivitis found a statistically significant reduction from baseline ocular itching scores compared to vehicle at all timepoints. Investigator-assessed ocular redness (a secondary endpoint) also saw a statistically significant reduction for patients who used reproxalap. Other secondary endpoints—change from baseline in patient-reported ocular tearing scores and change from baseline in total ocular severity scores—also showed a significant difference between the reproxalap and vehicle groups. The company has already submitted an NDA to the FDA for reproxalap for treatment of dry eye disease, which is under review. A PDUFA date for the drug for this indication is set for November 23.

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Phase 1b topline data on investigational dry eye drop

Allgenesis Biotherapeutics announced topline data from its Phase 1b clinical trial evaluating AG-80308, 0.001%, 0.03%, and 0.1% for a dose response as well as a second formulation of 0.03%. AG-80308 is described by the company’s press release as a first-in-class formyl peptide receptor agonist that is delivered as an aqueous solution eye drop. The study, which evaluated the drop BID for 3 months, found improvements in corneal staining, conjunctival staining, and tear production, as well as in several dry eye symptoms. AG-80308 0.001% in formulation A and 0.03% in formulation B had the best safety, tolerability, and efficacy, according to the company. Allgenesis stated that it will move on to Phase 2 studies with 0.001% and 0.03% in formulation B.

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First patients dosed in Phase 1b/2 trial for Wnt agonist antibody

EyeBio announced that it has dosed the first patients in its Phase 1b/2 trial of Restoret (EYE103), a tri-specific Wnt agonist antibody, that is designed to eliminate leakage occurring in vascular retinal diseases, according to the company’s press release. The company also described Restoret as a mimetic of norrin, a natural Wnt ligand in the eye. The trial is multicenter and two parts: an open-label, multiple ascending dose safety study and a dose-finding, single-masked comparative safety and preliminary efficacy study. Intravitreal injections of Restoret will be given to participants with neovascular AMD and DME on a 12-week regimen. The primary endpoints are safety and mean change in BCVA from baseline to week 12, the company reported.

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Study: U.S. prevalence of diabetic retinopathy

Data published in JAMA Ophthalmology updated estimates for diabetic retinopathy prevalence by demographic factors in the U.S. According to the paper, data for this analysis came from the National Health and Nutrition Examination Survey (2005–2008 and 2017–March 2020), Medicare fee-for-service claims (2018), commercial insurance claims, and other sources. The authors estimated that in 2021, 9.6 million people in the U.S. had diabetic retinopathy, for a prevalence rate of 26.43% among individuals with diabetes. Of these, 1.84 million people had vision-threatening diabetic retinopathy, for a prevalence of 5.06%. The authors concluded that diabetic eye disease prevalence remains high and varies based on certain demographic and geographic characteristics.

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ASCRS news and events

• ASCRS Summer Meeting: The ASCRS Summer Meeting is back in Nashville, Tennessee, August 11–13. Early bird registration pricing ends Monday, June 26. Hotel reservations must be made by July 14 to receive the discounted meeting rate.
• Cataract Awareness Month: June is Cataract Awareness Month. Follow ASCRS on social media to keep up with the latest on this important awareness effort.

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Research highlights

• Rotational stability of the Tecnis Eyhance Toric II over a 3-month period was the topic of a prospective, unmasked, single-center study published in the Journal of Cataract & Refractive Surgery. According to the paper, 50 eyes of 50 patients with regular corneal astigmatism of 0.75 D or more and a need for cataract surgery were included. The Eyhance Toric II was implanted in 1 eye of each participant. Images of alignment axis were taken intraoperatively and postop 1 hour, 1 week, and 3 months. The authors wrote that toric IOL rotation was measured with images superimposed on the basis of ocular landmarks. Uncorrected and corrected distance and intermediate visual acuities were also assessed at 3 months. The investigators found no significant rotation in the 3-month period; no patients had to have repositioning of the IOL. There was a significant reduction in refractive cylinder from preop to 3 months postop.
• An article published in the journal Ophthalmology sought to identify patient characteristics that were associated with “eyecare utilization and likelihood of blindness.” Using IRIS Registry data, which included more than 19.5 million patients with visual acuity records in 2018, the retrospective observational study found that 0.98% of patients were legally blind (20/200 or worse) due to low visual acuity; legal blindness was associated with smoking, rural location, public or no insurance, and older age. The authors reported that compared to U.S. Census estimates and other population estimates, minorities may be underrepresented among ophthalmology patients and Black individuals overrepresented among blind patients in the IRIS Registry data. The authors wrote that the findings of this analysis “provide a snapshot of US ophthalmic care and highlight need for initiatives to address disparities in utilization and blindness.”

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Product news

• Zeiss Vision Care launched Zeiss Warm Eye Masks, individually wrapped and disposable eye masks intended to help unblock meibomian glands.

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