Updates you may have missed: Clinical trials, funding, and shelved projects

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With the busy holiday season and the winter weather hitting much of the United States in the first few days of 2025, there have been many things on the minds of our readers that may not have been ophthalmology related.

That’s why we are here to catch you up on the clinical trial news, updates from the United States Food and Drug Administration (FDA), and company funding that you may have missed.

Caplin Steriles Limited

Caplin Steriles Limited has been granted final approval from the FDA for its Abbreviated New Drug Application (ANDA) difluprednate ophthalmic emulsion, 0.05%.

These eye drops are a generic therapeutic equivalent version of the reference listed drug (RLD) DUREZOL, from Sandoz Inc.¹ The eye drops are topical corticosteroid that is indicated in the treatment of inflammation and pain associated with ocular surgery, and in the treatment of endogenous anterior uveitis.²

Zhaoke Ophthalmology Ltd

Zhaoke Ophthalmology Limited announced positive top-line results from the phase 3 clinical trial of TAB014 for the treatment of wet age-related macular degeneration (AMD). The results of this trial note that TAB014 met its primary and key secondary endpoints. The company has secured full control over the clinical development and commercialization of TAB014 in China, Hong Kong, and Macau through an agreement with TOT BIOPHARM.³

Valo Health

Valo Health will no longer develop OPL-0401, a drug candidate for diabetic retinopathy, on its own after a phase 2 readout, but will seek a partner to take the program forward. According to the company, OPL-0401 did not meet either the primary or secondary endpoints of the SPECTRA trial, but the company added that the drug was well-tolerated and some of the data points to potential for preventing disease progression in diabetic retinopathy.⁴

Valo Health plans to adjust focus to its efforts on using its AI-tool, Opal, to "discover new therapeutic targets in real-world data, validate those targets in human-centric models, and develop new medicines with [its] AI-enabled closed loop small molecule design," said chief executive Brian Alexander, who is also CEO-Partner of Flagship Pioneering.⁴

GEMMABio

GEMMABio has raised $34 million in seed funding to help advance its portfolio of gene therapy programs. The seed round was led by Double Point Ventures, Bioluminescence Ventures and Earlybird Venture Capital, with additional backing from Savanne Life Sciences.⁵

Building on a $100m boost secured by GEMMABio in October, the company said it will manufacture and test 6 gene therapies in Brazil. The therapies are targeting a range of rare and diseases. GEMMABio secured the funds via a partnership with Fiocruz to sponsor research that will bring gene therapy treatments to the people of Brazil under Brazil’s publicly funded health care system, the Sistema Único de Saúde (SUS).⁵

References:

1. Caplin steriles gets USFDA approval for difluprednate ophthalmic emulsion. Caplin Steriles Limited. December 16, 2024. Accessed January 6, 2025. https://www.caplinsteriles.net/index.php/2024/12/16/caplin-steriles-gets-usfda-approval-for-difluprednate-ophthalmic-emulsion/

2. Caplin Point arm gets USFDA nod for difluprednate eye drops. Caplin Steriles Limited. December 16, 2024. Accessed January 6, 2025. https://www.business-standard.com/markets/capital-market-news/caplin-point-arm-gets-usfda-nod-for-difluprednate-eye-drops-124121600424_1.html

3. Zhaoke Ophthalmology Reports Posititve Trial Results for TAB014. January 1, 2025. Accessed January 6, 2025. https://www.tipranks.com/news/company-announcements/zhaoke-ophthalmology-reports-positive-trial-results-for-tab014

4. Flagship-backed AI startup Valo shelves eye disease drug. Valo Health. January 2, 2025. Accessed January 6, 2025. https://pharmaphorum.com/news/flagship-backed-ai-startup-valo-shelves-eye-disease-drug

5. GEMMABio raises $34m to advance gene therapy programmes. GEMMABio. December 24, 2024. Accessed January 6, 2025. https://finance.yahoo.com/news/gemmabio-raises-34m-advance-gene-140125903.html