First patients dosed in Phase 3 program evaluating sustained drug delivery for DME

The first patients were dosed in the two Phase 3 clinical trials being conducted by EyePoint to evaluate DURAVYU (vorolanib intravitreal insert) as a sustained-drug delivery option for treatment of diabetic macular edema (DME). According to the company’s press release, vorolanib is a selective tyrosine kinase inhibitor that “brings a novel, multi-mechanism of action inhibiting VEGF-mediated vascular permeability, PDGF, and IL-6 mediated inflammation to the potential treatment of DME.” The two non-inferiority trials are randomized, double-masked, with aflibercept serving as the on-label control. The trials include both treatment-naïve and previously treated patients, enrolling about 480 patients in total. The primary endpoint is non-inferiority to aflibercept in change from baseline in BCVA at weeks 52 and 56. Secondary endpoints are safety, reduction in treatment burden, percentage of eyes without supplemental aflibercept injections, as well as other anatomical results. Topline data from these studies are expected in the second half of 2027.

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FDA accepts supplemental NDA for presbyopia treatment

Opus Genetics announced FDA acceptance for review of its supplemental New Drug Application (NDA) for phentolamine ophthalmic solution, 0.75%, for treatment of presbyopia. The drop, which is currently FDA approved as Ryzumvi for pharmacologically induced mydriasis, is designed to “modulate pupil dynamics and improve visual acuity through a sympatholytic mechanism of action that avoids engaging the ciliary muscle.” The company noted that the supplemental NDA, which would expand the current indication to include presbyopia, is supported by two Phase 3 trials, one of which will be presented at the upcoming ASCRS Annual Meeting. According to the company, the PDUFA goal date is October 17.

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FDA grants IND to ocular inflammation, pain treatment for potential expanded indication

Harrow announced that the FDA approved its Investigational New Drug (IND) application for a Phase 3 clinical trial to evaluate TRIESENSE (triamcinolone acetonide injectable suspension), 40 mg/mL, currently approved for intraocular use for inflammation, for a possible expanded indication for treatment of ocular inflammation and pain following cataract surgery. According to the company’s press release, a Phase 3 study will evaluate safety and efficacy of TRIESENSE in cataract surgery, likely to begin in the first quarter of 2026. The company aims to enroll about 250 patients for 2:1 TRIESENCE or placebo randomization. The primary endpoints will be absence of anterior chamber cells in the study eye at day 1 and absence of pain in the study eye at day 8 post-cataract surgery.

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Enrollment complete in Phase 3 trial evaluating retinitis pigmentosa therapy

Ocugen announced enrollment completion for its Phase 3 clinical trial evaluating OCU400 for treatment of retinitis pigmentosa. The company stated that topline data will be available in the first quarter of 2027, with positive data expected to support a Biologic License Application and potential approval later that same year. The trial enrolled 140 patients, randomized 2:1 into the treatment group and the untreated control group. The study included both RHO and gene-agonistic arms, with 3-year data from the Phase 1/2 trial showing durability, safety, and tolerability of OCU400 in a gene-agnostic population. The company reported that the current Phase 3 trial is the only broad retinitis pigmentosa gene-agnostic trial and the largest known Phase 3 orphan gene therapy trial.

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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.

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Research highlights

• A personalized intervention program (Support, Educate, Empower [SEE]) was evaluated compared to standard written education in terms of its effect on glaucoma medication adherence in a randomized, non-masked trial published in the journal JAMA Ophthalmology. More than 200 patients who were prescribed at least 1 IOP-lowering drop with a self-reported adherence of 85% or lower were enrolled. According to the study authors, the SEE intervention “is a 6-month motivational interviewing-based glaucoma health coaching program administered by a nonphysician counselor, including 3 in-person sessions, 4 between-visit phone calls, personalized multimedia glaucoma education, and automated medication reminders.” The control group received what the authors described as “usual care and 3 mailings of standard written glaucoma education.” Medication adherence as monitored with AdhereTech and “change in glaucoma-related distress” was also evaluated. The SEE intervention was given to 117 participants, and 118 received control care. The authors found that medication adherence was “significantly better in the SEE intervention group,” with 77.6% of SEE participants adherent compared to 58% who received standard care. The authors noted that more participants achieved 80% or greater adherence in the SEE group. “The difference in change in glaucoma-related distress between intervention and control was −0.3 (95% CI, −0.5 to −0.1) after adjusting for baseline distress.” With this, the authors concluded that the SEE program was an “evidence-based method to improve medication adherence necessary to improve glaucoma outcomes.”
• The long-term results of LASIK with combined accelerated corneal crosslinking, known as LASIK-Xtra, was compared to LASIK without crosslinking in highly myopic eyes in a prospective, randomized, fellow eye-controlled clinical trial published in the Journal of Cataract & Refractive Surgery. The study enrolled 13 patients with 26 eyes treated with the two types of LASIK. The authors found UDVA and CDVA between the two groups to be “insignificantly different” at 1 year postop and at 8 years postop. They found the safety index at 8 years postop to be 1.09 for conventional LASIK and 1.15 for LASIK-Xtra. There were “significant myopic shifts in spherical equivalent” between postop year 1 and postop year 8 in the conventional LASIK group compared to the LASIK-Xtra group. The authors noted that these shifts “cannot be fully attributed to corneal alterations alone and may also reflect other factors.” Ultimately, they concluded “no substantial disparities in efficacy and safety indices were observed between the 2 groups. There were no substantial differences in most of the evaluated postoperative corneal biomechanical parameters between the 2 groups.” The authors noted that the findings should be validated with larger sample sizes.

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Product news

• Rayner acquired U.S. distribution rights for Anikavisc, an ophthalmic viscosurgical device from Visco Technologies.

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