Sightlines: August in Review
The ophthalmology landscape in August was marked by a mix of regulatory setbacks, promising clinical milestones, and significant corporate restructuring.
Outlook Therapeutics, Inc. faced another roadblock in its pursuit of FDA approval for ONS-5010 (bevacizumab-vikg). The FDA issued a Complete Response Letter for the company’s resubmitted Biologics License Application, citing insufficient evidence of efficacy after the pivotal NORSE EIGHT trial failed to achieve its primary endpoint. While Outlook had hoped its clinical package would meet regulatory expectations, the FDA made clear that additional confirmatory data will be required. The company now plans to meet with regulators to chart a path forward, with European filings also on the horizon.
Regulatory caution was also evident in the case of Regeneron 's high-dose aflibercept, EYLEA HD. The FDA extended its target action date for two pending submissions, including a post-approval supplement for chemistry, manufacturing, and controls as well as a supplemental BLA for additional retinal indications. The extensions followed a major amendment related to inspection findings at a manufacturing facility, pushing potential approval decisions into the fourth quarter of 2025.
Despite these regulatory delays, August brought encouraging progress in clinical development. Qlaris Bio, Inc. announced that the first patient has been dosed in its Phase II Nightingale trial evaluating QLS-111 for normal-tension glaucoma. The investigational therapy, a first-in-class ATP-sensitive potassium channel modulator, targets episcleral venous pressure as a novel mechanism to reduce intraocular pressure in patients for whom traditional approaches have limited effect. In another milestone, the first FDA-approved treatment for macular telangiectasia type 2, ENCELTO, moved into commercial use. The gene therapy, which had secured approval earlier this year, was manufactured, shipped, and surgically implanted outside of clinical trial settings for the first time—an important step in bringing treatment access to patients with this rare degenerative condition.
The month also saw significant shifts in the business landscape. Opthea announced a dramatic downsizing, cutting more than 80% of its workforce following the discontinuation of sozinibercept, its lead candidate for wet AMD. The restructuring was accompanied by leadership changes, with the CEO and other senior executives set to depart in September. Meanwhile, PainReform Ltd acquired a majority stake in LayerBio, Inc , gaining control of its sustained-release OcuRing-K implant designed to deliver ketorolac during cataract surgery. The platform, which attaches to intraocular lenses, is being positioned as a “dropless” alternative to standard postoperative regimens.
Mergers and acquisitions also played a central role this month, most notably Alcon ’s agreement to acquire STAAR Surgical in a $1.5 billion deal. The acquisition will add STAAR’s EVO ICL implantable lenses to Alcon’s growing portfolio, broadening its reach in the vision correction surgery market. The transaction is expected to close within the next year, pending regulatory and shareholder approvals.
On the therapeutic front, long-term data provided encouraging news for retinal specialists. Genentech reported five-year results from the Portal study of Susvimo, showing durable vision outcomes and retinal drying in patients with wet AMD. Remarkably, 95% of participants required only biannual refills without supplemental treatment over the full five years, reinforcing Susvimo’s potential as an alternative to frequent intravitreal injections. At the same time, Alcon announced the U.S. launch of Tryptyr (acoltremon ophthalmic solution 0.003%), a novel TRPM8 receptor agonist that boosts natural tear production in patients with dry eye disease. Early data suggest the therapy can provide symptomatic relief as soon as the first day of treatment, and the company is supporting the launch with educational resources and patient-access programs.
Taken together, the developments of August 2025 reflect a field in transition—where regulatory rigor continues to shape approval timelines, innovative therapies are beginning to reshape standards of care, and companies are strategically repositioning themselves in an increasingly competitive environment.