FDA grants IDE for synthetic endothelial layer study

EyeYon Medical has received FDA approval for its Investigational Device Exemption (IDE) to begin a U.S. clinical study for EndoArt, described in the company’s press release as “the world’s first synthetic endothelial layer for treatment of chronic corneal edema.” According to the company, EndoArt has the CE mark in Europe and has been through many studies outside the U.S. with more than 800 implantations worldwide and up to 7 years of follow-up data “showing long-term corneal clarity, stability, and sustained therapeutic benefit.”

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NDA submission for wet AMD treatment advances

Ocular Therapeutix announced its intent to accelerate its timeline for the New Drug Application (NDA) submission for AXPAXLI (OTX-TKI) for treatment of wet AMD. This submission would occur provided there is positive 1-year data from its Phase 3 clinical trial, which is currently on track to be reported within the first quarter of 2026. The company noted in its press release that the FDA, which has historically required two Phase 3 clinical trials for ophthalmic product candidates, has indicated it is “potentially moving to requiring only a single registrational trial, as long as the trial is adequately powered and controlled.” The company thinks that based on its Special Protocol Assessment for the Phase 3 trial and the trial’s design that it may be able to submit an NDA based on the results from this single trial. The company reported that it will engage the FDA for next steps regarding the regulatory pathway for AXPAXLI.

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Positive feedback moves forward NDA submission plans

Azura Ophthalmics announced that after positive feedback from its pre-New Drug Application (NDA) meeting with the FDA, it thinks it has sufficient support for and is moving forward with its plan for an NDA submission in the second half of 2026 for AZR-MD-001. According to the company’s press release, the company’s two (soon to be three) studies support its application for the topical, twice-weekly ophthalmic keratolytic therapy intended to treat meibomian gland dysfunction.

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Company news

• Carl Zeiss Vision International announced completion of its acquisition of Brighten Optix, a move to expand the company’s myopia management portfolio.
• Formosa Pharmaceuticals announced an exclusive licensing agreement with Rxilient Medical for rights to commercialization of clobetasol propionate ophthalmic suspension, 0.05%, for treatment of pain and inflammation following ocular surgery in several regions.
• Iolyx Therapeutics entered into a strategic development and commercialization agreement with Laboratoires Théa, granting Théa exclusive worldwide rights (excluding Asia) to ILYX-002 for treatment of ocular surface disease.

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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, 2026. Get involved with the meeting by submitting a case video—learn more.
• 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.

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Research highlights

• A retrospective longitudinal study demonstrated the efficacy and safety of iris-claw phakic IOLs (pIOLs) for treatment of post-keratoplasty astigmatism. The study, published in the Journal of Cataract & Refractive Surgery, included 39 eyes of 29 patients who had iris-claw pIOL implantation after previous PK or DALK. Patients who had other refractive procedures or less than 1 year of follow-up were excluded. The investigators found that 19 eyes (49%) at a postop visit between 12–18 months had a UDVA of 20/32 or greater, and 6 (15%) were 20/20 or greater. Full refractive correction without loss of CDVA was observed in 16 (11%) patients, while 9 (23%) gained 1 or more lines of vision, and 28 (72%) were within 1 D of plano refraction. Residual astigmatism of 1 D or less occurred in 25 (64%) of eyes. The investigators noted that average annual endothelial cell loss was 3.07% in patients who had DALK and 9.34% in patients who had PK, and as such, they advocated for “strict” and “mandatory” follow-up. Ultimately, the iris-claw pIOL was determined to be effective for treating post-keratoplasty astigmatism.
• The authors of a small prospective study published in the journal Clinical Ophthalmology hypothesized that a small amount of induced astigmatism would not be clinically relevant for patients implanted bilaterally with an EDOF IOL, specifically the AT LARA (Zeiss). The study included 20 eyes of 20 patients and showed tolerance of up to 1 D of induced astigmatism. However, there were “significant reductions in visual acuity at higher magnitudes of astigmatism.” What’s more, the authors reported that tolerance for astigmatism was higher when it was against-the-rule, with “[against-the-rule] preserving intermediate and near vision and [with-the-rule] favoring distance.”

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