FDA approves new drug for postop inflammation and pain

Formosa Pharmaceuticals and AimMax Therapeutics received FDA approval for clobetasol propionate ophthalmic suspension, 0.05%, (APP13007) for treatment of postop inflammation and pain following ocular surgery. According to Formosa’s press release, the drug uses the company’s nanoparticular formulation platform, and this is the first approval for ophthalmic clobetasol propionate. The company reported that in two Phase 3 clinical trials, the twice-daily drop showed a “rapid and sustained clearance of inflammation and pain relief … was statistically and clinically superior to its matching placebo.”

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Primary endpoints in unadjusted population not met in Phase 3 trial for dry eye drop

Palatin Technologies announced that its primary endpoints in a Phase 3 clinical trial for its dry eye drop PL9643 did not meet statistical significance compared to vehicle. When the primary endpoints were adjusted for “intent to treat” based on age and gender though, the company reported that PL9643 “demonstrated clinically meaningful (visual analog score reduction of >10 points from baseline) and statistically significant results for the co-primary symptom endpoint of pain and multiple other endpoint symptoms.” The co-primary sign endpoint (conjunctival lissamine green staining) did not achieve statistical significance in the intent-to-treat population, but it and secondary sign endpoints showed positive treatment effects over vehicle, the company reported. PL9643 was well tolerated.

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Study links inherited eye diseases to gut bacteria

Research from the University College London (UCL), published in the journal Cell, have associated certain inherited eye diseases to gut bacteria. According to the news article from UCL, the research, which was conducted with a team in China, “[suggests] that a genetic mutation could relax the body’s defenses, thus allowing harmful bacteria to reach the eye and cause blindness.” The team specifically investigated the CRB1 gene, which is involved in building the blood-retina barrier. Mutations in this gene are associated with types of Leber congenital amaurosis and retinitis pigmentosa. In mouse models, the investigators showed that the gene controls “integrity of the lower gastrointestinal tract … regulating what passes between the contents of the gut and the rest of the body.” When the gene has a certain mutation, they observed that the barriers in the retina and gut can be breached. They also found that when mice with this mutation were given antibiotics, vision loss was prevented even though the cell barriers remained compromised.

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Acquisitions and other news

• Amring Pharmaceuticals changed its name to Nordic Pharma.
• Sandoz acquired CIMERLI, a ranibizumab biosimilar from Coherus Biosciences.

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ASCRS news and events

• ASCRS Annual Meeting: The cost to attend the ASCRS Annual Meeting goes up after March 13. Register before then and get ready to experience education, networking, the 50th anniversary celebration, and more from the premier meeting dedicated to education in anterior segment surgery, April 5–8 in Boston, Massachusetts. Take a look at the 2024 Annual Meeting & Subspecialty Day Real-Time Program for more details.
• EyeWorld Corporate Events: EyeWorld is hosting more than a dozen Corporate Education events during the ASCRS Annual Meeting in Boston. Click here to learn more about these opportunities as well as pre-register.

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Research highlights

• The prescribing patterns of topical and intraocular/periocular anti-inflammatory medications after cataract surgery were identified in a cross-sectional survey with results published in the Journal of Cataract & Refractive Surgery. The survey got a 23% response rate—217 surgeon respondents. Of these, most practiced in the U.S. (79%), and most were corneal subspecialists (79%). Most (97%) prescribed topical steroids after cataract surgery, with the most frequently prescribed drug being prednisolone acetate (83%), followed by dexamethasone (13%), difluprednate (12%), and loteprednol etabonate (7%). Triamcinolone acetonide was the most commonly used intraocular/periocular injection. Of the surgeons who used intraocular/periocular corticosteroids, 58% still prescribed topical corticosteroids as well. Topical nonsteroidal anti-inflammatories were prescribed postop by 73% of surgeons. The authors concluded that “diversity of practice patterns may reflect the lack of clear evidence-based guidelines.”
• A preservative-free drop regimen after cataract surgery was compared to a regimen that included drops preserved with BAK in patients with and without dry eyes. According to the paper published in Clinical Ophthalmology, dry eye exams were performed preop and 6 weeks after cataract surgery. Patients were considered to have dry eye if one of the assessment tests were abnormal. Patients were randomized into a group that received dexamethasone and bromfenac with BAK after cataract surgery (group 1) and a group that had preservative-free dexamethasone, preservative-free diclofenac, and a preservative-free lubricant (group 2). A third group included patients who did not have dry eye preop; these patients received the same postop regimen as group 1. According to the paper, the number of patients with signs of dry eye decreased significantly in both groups 1 and 2. Corneal sensitivity and meibomian gland dysfunction parameters got worse postop, but the authors reported improvements in patient-reported symptoms, osmolarity, non-invasive tear breakup time, corneal fluorescein staining, and tear film thickness. Patients in group 3 who originally had normal tear film status saw an increase in signs of dry eye after cataract surgery. The authors noted that there were not statistically significant differences in tear film parameters among the three groups.

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Product news

• iDose TR (travoprost intracameral implant, Glaukos) using VitalDose EVA (Celanese) began its commercial launch.

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