Ophthalmology ·
Kodiak's tarcocimab meets DAYBREAK end point; EyeCare Partners agrees to sell optometry business; Aldeyra plans reproxalap appeal
THE SHORT READ
Kodiak Sciences said Sept. 28 that tarcocimab tedromer and tabirafusp-ted met their primary end points against aflibercept in the phase 3 DAYBREAK trial in wet age-related macular degeneration (AMD).
EyeCare Partners agreed to sell its optometry business to MyEyeDr., Aldeyra Therapeutics said it would formally dispute the Food and Drug Administration (FDA) rejection of reproxalap for dry eye disease, and Atsena Therapeutics reported 18-month gene therapy results in X-linked retinoschisis.
THE DETAILS
- Research Sept 28, 2026Kodiak Sciences said Sept. 28 that tarcocimab tedromer (Zenkuda) and tabirafusp-ted met the DAYBREAK primary end point, noninferiority to aflibercept in best-corrected visual acuity change from baseline to the average of weeks 40, 44 and 48 (P = .0007 and P = .0036, respectively). Tarcocimab was dosed every four to 24 weeks as needed after four monthly loading doses, and 54% of patients reached six-month dosing at year one under strict treat-to-dryness retreatment criteria. Intraocular inflammation rates were 0% with tarcocimab and 0.4% with tabirafusp-ted. Kodiak plans a multi-indication biologics license application for tarcocimab in the fourth quarter of 2026.Sources: Kodiak Sciences, Ophthalmology Times
- Business Sept 29, 2026EyeCare Partners said it agreed to sell its optometry business to MyEyeDr., with closing expected in the fourth quarter of 2026, subject to regulatory approvals, and that the transaction will let it sharpen its focus on its ophthalmology and ambulatory surgical center businesses. The deal adds more than 300 offices under the Clarkson Eyecare, EyeCare Associates, EyeCare Center, Nationwide Vision and The Eye Doctors brands to MyEyeDr.'s network, Eyewire+ reported Sept. 29. Financial terms were not disclosed.Sources: EyeCare Partners, Eyewire+
- FDA Sept 29, 2026Aldeyra Therapeutics announced Sept. 29 that it intends to submit a formal dispute resolution request to the Food and Drug Administration (FDA) for reproxalap, an investigational drug for dry eye disease, to appeal the March 16, 2026, complete response letter that denied approval. The company said the most recent complete response letter did not request further clinical trials but stated that the "totality of evidence from the completed clinical trials does not support the effectiveness of the product." Aldeyra expects to submit the request and meet with the FDA's Office of New Drugs in the fourth quarter of 2026.
- Research Sept 30, 2026Atsena Therapeutics reported 18-month results Sept. 30 from Part A of the phase 1/2/3 LIGHTHOUSE trial of ATSN-201 in X-linked retinoschisis (XLRS), presented at the American Academy of Optometry 2026 Annual Meeting. Foveal schisis closure was maintained in seven of nine treated eyes, a result not observed in untreated eyes, and seven of nine treated eyes gained at least 10 letters of best-corrected or low-luminance visual acuity, compared with one of nine untreated eyes. The company reported no drug-related serious adverse events, dose-limiting toxicities or patient discontinuations.Source: Atsena Therapeutics
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