NDA submitted for presbyopia treatment

Lenz Therapeutics submitted a New Drug Application to the FDA for its aceclidine eye drop (LNZ100) intended for temporary correction of presbyopia. The NDA, according to the company’s press release, is supported by data from the Phase 3 pivotal trial, which achieved all of its primary and secondary near vision endpoints, providing a statistically significant improvement in 3 lines or greater improvement in BCVA at near without losing 1 or more lines of distance visual acuity. There were no serious treatment-related adverse events.

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FDA approves AMD treatment

Sandoz announced that it received FDA approval for Enzeevu (aflibercept-abzv, 2 mg) for intravitreal injection for patients with AMD. According to the company, it is indicated to improve and maintain visual acuity for these patients. The company also stated that the FDA “provisionally determined Enzeevu would be interchangeable with the reference medicine.”

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Primary endpoint achieved in Phase 3 trial of reproxalap for dry eye

Aldeyra Therapeutics announced that its Phase 3 clinical trial for reproxalap ophthalmic solution, 0.25%, for treatment of dry eye disease reached its primary endpoint of a statistically significant improvement in ocular discomfort compared to vehicle. The study took place in a dry eye chamber and represents, according to the company, the first positive Phase 3 results with a symptom as the primary endpoint. The study included 132 patients who were randomized 1:1 to vehicle or reproxalap. Ocular discomfort was measured between 80–100 minutes in the dry eye chamber. Based on these results, the company plans to submit a New Drug Application to the FDA this year.

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Clinical trial results that supported new excimer laser approval published

Bausch + Lomb published the results of its clinical trial that supported FDA approval in January of this year of the TENEO Excimer Laser. In the Journal of Refractive Surgery, the pivotal study, which included 168 participants who had LASIK with the TENEO platform, showed that 97.8% and 100% of eyes achieved UDVA and CDVA of 20/25 or better, respectively, 9 months after surgery. Nearly 93% of eyes had a residual refractive error that was within 0.5 D of target. Participants completed the PROWL questionnaire preop and postop, which found that satisfaction with vision was 27.7% preop and increased to 98.1% postop.

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Company updates on several clinical trials

Ocuphire Pharma provided clinical and regulatory updates on several of its product candidates. It is in discussions with the FDA regarding its Special Protocol Assessment for APX3330 for diabetic retinopathy. Its Phase 3 trial evaluating phentolamine ophthalmic solution, 0.75%, for treatment of presbyopia is in a recruitment stage, expected to enroll up to 545 participants at up to 40 sites in the U.S. Topline results for this trial are expected in 2025. The same phentolamine product candidate is also enrolling for a Phase 3 registration study evaluating its treatment for decreased visual acuity in low light conditions after keratorefractive surgery.

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First patient dosed in Phase 2 trial for intravitreal steroid implant for DME treatment

Eclipse Life Sciences announced that it enrolled and dosed its first patient in a Phase 2 trial for EC-104, a fluocinolone acetonide intravitreal corticosteroid implant that is intended to provide 6 months of drug delivery for the treatment of diabetic macular edema (DME). This randomized, controlled, double-masked, Phase 2 trial will compare a 0.14 mg and a 0.092 mg dose of EC-104 to Ozurdex (dexamethasone intravitreal implant, 0.7 mg, AbbVie). Patients enrolled in the trial have had a suboptimal response to anti-VEGF therapy, according to the company’s emailed press release, and have not had a clinically significant rise in IOP after using local corticosteroids. The primary endpoint of the study is safety; the secondary endpoint is efficacy determined by anatomic durability of treatment response through week 24 as seen on SD-OCT.

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ASCRS news and events

• ASCRS Business of Refractive Cataract Surgery Summit: This new course—along with its extensive, take-home resource library—will help practices gain the navigational tools needed to increase advanced-technology IOL adoption and lead patients effectively on their refractive surgery journey. Learn more.
• ASCRS Live! This educational dinner series is heading to nine cities across the U.S. Registration is open for events in Cleveland, Ohio, September 12 and Atlanta, Georgia, October 3.
• ASCRS Annual Meeting: The call for abstract submissions for the 2025 ASCRS Annual Meeting closes August 26. Submit your abstracts now.
• ASCRS Foundation: Residents, fellows, and surgeons within their first 5 years of practice with an interest in global eyecare are encouraged to apply for the Young Eye Surgeons International Service Grant. Learn more here.
• 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

• A retrospective cohort study published in the Journal of Cataract & Refractive Surgery evaluated the clinical significance of preop OCT of the retinal nerve fiber layer thickness for glaucoma identification and management of patients scheduled for cataract surgery. The study, which enrolled patients from February 2022 to August 2022 at a single medical center in Israel, compared the retinal nerve fiber layer OCTs evaluated by a glaucoma specialist to the referring ophthalmologist’s preop fundus exams. The main outcome was incidence of glaucoma newly detected with the OCT and subsequent changes to the patient’s management. The study included 486 patients, identifying 112 with an abnormal retinal nerve fiber layer (23%). Of these, 31 patients’ (6.4%) abnormal findings were attributed to non-glaucoma comorbidities, while 81 patients (16.7%) were thought to be glaucoma suspects based on the OCT findings, and 44 patients (9%) had been newly diagnosed as glaucoma or glaucoma suspects. In terms of management modifications in light of the OCT findings, 5.1% of patients initiated routine glaucoma follow-up, 2.5% were started on IOP-lowering drops, and 1.4% were converted to a combined cataract-glaucoma procedure. The authors concluded that OCT of the retinal nerve fiber layer was “valuable in detecting glaucoma that had not been revealed by standard fundus biomicroscopic examination.”
• Subgroup analysis of a Phase 1/2 clinical trial evaluated efficacy of topical EDTA ophthalmic solution (C-KAD), 2.6%, to improve visual function in a group of patients who lost contrast sensitivity due to early stage, age-related cataracts. According to the study, published in the American Journal of Ophthalmology, patients had contrast sensitivity scores between 1–7 grating patches. Forty-one eyes were included in the analysis (21 received treatment, 20 received placebo). At day 120 after treatment, 66.7% of patients in the treatment group, compared to 35.0% in the placebo group, achieved what was equivalent to 100% contrast sensitivity improvement. Overall, a “significant treatment effect of C-KAD in visual function and vision quality was observed consistently,” suggesting this could be “a novel, non-invasive pharmacological treatment to improve vision in patients with early-stage cataract,” according to the authors.

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