FDA issues another response letter for dry eye NDA

Aldeyra Therapeutics announced that it received another (its third) Complete Response Letter from the FDA regarding its New Drug Application (NDA) for reproxalap for treatment of dry eye disease. According to the company, the letter said the FDA believed there was “a lack of substantial evidence consisting of adequate and well-controlled investigations … that the drug product will have the effect it purports or is represented to have under the conditions of use prescribed, recommended, or suggested in its proposed labeling” and that “the application has failed to demonstrate efficacy in adequate and well controlled studies in the treatment of signs and symptoms of dry eye disease.” The letter also noted “inconsistency of study results [raising] serious concerns about the reliability and meaningfulness of the positive findings.” While label drafts were provided to the FDA in December 2025 and March 2026, Aldeyra stated that it “does not believe that label negotiations were completed.” The company addressed other concerns of the FDA in its press release and stated that it will “work with urgency to support the FDA in enabling market access” to reproxalap.

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FDA denies approval for LHON NDA

The FDA issued a Complete Response Letter to Chiesi Global Rare Diseases for its New Drug Application (NDA) for idebenone for treatment of teens and adults with Leber hereditary optic neuropathy (LHON). The company’s press release stated that the FDA was “unable to approve the application in its current form.” A request for more data was made, as well as clarification on other areas.

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Commercial launch of epithelium-on crosslinking in the U.S.

Glaukos announced the commercial launch of its FDA-approved epithelium-on crosslinking system, Epioxa HD/Epioxa, for treatment of keratoconus. Epioxa received FDA approval in 2025. With this commercial launch, Glaukos created a patient-support resource portal—EpioxaCareConnect—to help with prior authorization, appeals, and financial assistance.

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Company news

• Alcon and LENSAR announced their plan to terminate their previous merger agreement. According to a statement from Alcon’s CEO, this decision was made due to the delay and costs associated with an extended regulatory review.

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ASCRS news and events

• 2026 ASCRS Annual Meeting: Register now for the 2026 ASCRS Annual Meeting in Washington, D.C., April 10–13. View the Real-Time Program for the most up-to-date program information.
• SightLine at ASCRS: Connect, collaborate, and confront the challenges shaping the commercial landscape of ophthalmology at this meeting taking place Thursday, April 9 ahead of the ASCRS Annual Meeting. This meeting is for all commercial stakeholders in ophthalmology to learn about care delivery ideas that will forge a more sustainable financial future. Learn more.
• Business of Interventional Glaucoma: Surgeons and practice administrators alike are invited to the ASOA ASCRS Business of Interventional Glaucoma program, taking place Thursday, April 9 ahead of the ASCRS Annual Meeting and ASOA Annual Meeting. Learn more.
• New issue of EyeWorld: The Spring edition of EyeWorld is now available as a digital magazine-style flipbook. Click here to read Annual Meeting preview articles and clinical content.

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Research highlights

• A retrospective, multicenter, cohort study based on EHR data from 69 U.S.-based healthcare organizations, in both outpatient and academic ophthalmology settings, sought to evaluate whether post-cataract YAG laser capsulotomy caused progression of diabetic retinopathy. The study included adult patients with type 1 or type 2 diabetes and diagnosed non-proliferative diabetic retinopathy (n=10,750) who either did (n=5,375) or did not (n=5,357) need a YAG capsulotomy after cataract surgery. After 1 year, the investigators found that patients who had YAG were at higher risk for developing proliferative diabetic retinopathy, vitreous hemorrhage, tractional retinal detachment, and the need for panretinal photocoagulation. Secondary analysis showed patients with 5 or more years of non-proliferative diabetic retinopathy were also at elevated risk for these conditions after YAG, the authors reported. As such, they concluded that patients with non-proliferative diabetic retinopathy were at higher risk for progression and vision threatening complications, meriting closer screening and follow-up after YAG. This research is published in the Journal of Cataract & Refractive Surgery.
• Two phacoemulsification settings—burst mode and continuous torsional mode with the Centurion Vision System (Alcon)—were compared in a prospective comparative study for their efficacy and safety in hard nucleus extraction. More than 200 patients with grade III–V cataracts were assigned to group A (combined mode, n=100) or group B (torsional mode, n=107) for cataract surgery, and endothelial cell density (ECD), central corneal thickness (CCT), and BCVA were evaluated and postop day 1, week 1, month 1, and month 3. Patients in group A had lower cumulative dissipated energy, compared to those in group B. Both showed a decrease in ECD, but the decrease was lower in group A. There was an increase in CCT at postop day 1 and postop week 1 in both groups, but the changes in CCT were greater in group B. The authors concluded that “burst torsional combined with longitudinal ultrasound can be more effective for harder nuclei phacoemulsification than the continuous torsional ultrasound.” The study was published in the journal Clinical Ophthalmology.

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Product news

• A new AI-powered diagnostic tool, the PretestPro (Heru), was launched to run a pretest exam, including 8-point confrontation visual field, near cover test, extraocular motility, and quantitative pupillometry, in under 2 minutes.
• LENZ Therapeutics has submitted a Marketing Authorization Application to the European Medicines Agency for VIZZ (aceclidine ophthalmic solution) 1.44%. VIZZ received FDA approval for treatment of presbyopia in 2025.

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