Orasis Announces Trial Results

• CSF-1, Orasis’ preservative preparation of 0.4% pilocarpine for presbyopia, has met the primary and secondary endpoints of its clinical trials, the company announced in April. At the annual meeting of the American Society of Cataract and Refractive Surgery, results from the phase 2b study of CSF-1 were reported, showing 40% of enrollees achieving at least 3 lines of distance vision gain (the primary endpoint) and 80% achieving at least a 2-line gain (the secondary endpoint). “In addition to meeting the primary endpoint, achieving the secondary endpoint of a 2-line or more gain is clinically meaningful, especially for early presbyopes whose near vision is not yet severely impacted,” said Marjan Farid, MD, the presenting author, in a press release.

A few days earlier, the company announced topline results from its phase 3 studies of CSF-1, NEAR-1 and NEAR-2. In these trials, the 8-day primary and secondary endpoints were met, with the drop showing a statistically significant 3-line gain in distance vision and no losses of 1 line or more. These gains were sustained out to 15 days, with adverse events of headache and instillation site pain occurring in less than 7% of participants.

“We are extremely pleased with these positive results, which mark a significant milestone for CSF-1 and Orasis, and they position us well to be the next product to launch in this exciting category,” said Elad Kedar, Orasis’ chief executive officer. “The potential of CSF-1 to provide a first-line treatment option for people living with presbyopia is promising and we look forward to working with regulatory authorities to advance CSF-1 toward commercialization.” The company expects to submit its phase 3 data to the FDA for approval by the end of the year.

Optimal Pupil Size with Vuity

• Pilocarpine 1.25% drops (Vuity, Allergan/AbbVie) improve vision in part by decreasing pupil size, but there is a trade-off between improved defocus blur and worsened diffractive blur. To determine whether there is an optimal pupil size to balance these figures, a team led by Karl Stonecipher, MD, of the University of North Carolina, and including scientists from AbbVie, analyzed data from the GEMINI phase 3 studies for FDA approval of Vuity. They presented their findings at May’s annual meeting of the Association for Research in Vision and Ophthalmology.

The study isolated 3 findings from the GEMINI studies: distance corrected near visual acuity (DCNVA) at 40 cm; corrected distance visual acuity (CDVA) at 4m; and pupil diameter for the nondominant eye. Smaller pupil size was found to be correlated with greater improvements in DCNVA, with 50.6% of participants gaining ≥3 lines of vision with pupil sizes 1.5 mm or smaller. However, with pupil sizes ≤2mm, CDVA began to suffer, with 5 letters of vision lost in 4.4% and 10.7% of participants with pupil sizes of >1.5 to ≤2.0 mm and ≤1.5 mm, respectively.

The study concluded that the optimal pupil size to optimize vision with Vuity is between 2 and 2.5 mm. The authors recommend that both near and distance vision be taken into account in optimizing pupil size.

Reference

1. Stonecipher K, Horn M, Chang D, et al. Optimal pupil size for near-vision improvement without distance-vision loss in the GEMINI studies of AGN-190584 for presbyopia. Invest Ophthalmol Vis Sci. 2022;63:ARVO E-Abstract 3712001.

Visus Launches Phase 3 Study of Brimochol

• Visus Therapeutics announced in March its launch of 2 planned phase 3 studies of Brimochol PF, its preservative-free topical combination of carbachol and brimonidine tartrate for the treatment of presbyopia. The double-blind, multicenter trials, called BRIO-I and BRIO-II, follow completion of the successful phase 2 VIVID study, which found that Brimochol was well tolerated and successful in demonstrating gains in visual acuity.

BRIO-I and BRIO-II will enroll approximately 170 and 500 participants with presbyopia, respectively. In BRIO-I, participants will be randomized to receive Brimochol PF, a preservative-free preparation of brimonidine without carbachol, or brimonidine without carbachol, whereas in BRIO-II, the brimonidine monotherapy arm is replaced by an arm administering vehicle as a control. All drops were administered once daily. “The initiation of our first phase 3 trial is a momentous occasion for Visus Therapeutics,” said Rhett Schiffman, MD, MS, MHSA, cofounder, chief medical officer, and head of research and development at Visus, in a press release. “We anticipate the phase 3 trial will generate the pivotal data required to support our New Drug Application, bringing us one step closer to offering a novel, preservative-free therapy for patients.” Initial data from the phase 3 trials are expected in the fourth quarter of this year.

Alcon Sells Its Millionth Trifocal

• Alcon announced in March that its Acrysof IQ PanOptix trifocal intraocular lens (IOL) surpassed more than 1 million implantations. “In recognizing one million PanOptix implants, we want to say ‘thank you’ to the ophthalmology community for continuing to care for cataract patients around the world,” said Alex Long, Alcon’s global vice president for cataract implantables in a press release. “The impact this IOL continues to have on patients’ lives and the testimonials we have received through the years inspire us to continue to help even more patients see brilliantly.”

In addition to passing the million milestone, the company also announced that it had received the Best Medical Technology award at the 50th Prix Galien USA. “Receiving the Prix Galien is a testament to the impact PanOptix has on the quality of life of cataract patients worldwide – with 99% stating they would choose the same lens again,” said Rob Scott, Alcon’s vice president for intraocular devices research and development in the same press release.

The Prix Galien is an international awards program operating in more than a dozen countries. It was founded in 1970 and takes its name from how the Greek physician Galen is known in French. Galen made important contributions to the development of modern medicine in the first and second centuries AD. ■