Registration completed for the VEGA-1 Phase 2 clinical trial for the treatment of presbyopia

Ocuphire Pharma Inc. today announced that it has completed its registration for the VEGA-1 Phase 2 clinical trial (NCT04675151) evaluating the safety and efficacy of a combined kit of 0.75% phentolamine (Nyxol) and low-dose pilocarpine in presbyopia.

According to the company, VEGA-1 successfully recruited 150 subjects in just under 3 months.

According to Mina Sooch, MBA, President and CEO of Ocuphire Pharma, achieving the enrollment completion goal for the VEGA-1 trial is another important milestone in the company’s Nyxol program and is helping to achieve top-notch results by the end of June.

“Nyxol has the potential to address multiple unmet needs first with the significant market opportunity in mydriasis reversal supported by our recent positive results from Phase 3 data and then adding this very large opportunity The presbyopia market estimated at over $ 5 billion in the United States alone, ”Sooch said in a statement. “We are excited to develop Nyxol with low dose pilocarpine as a potential option for the growing number of presbyopic patients and also to realize commercial synergies if the products are approved given the target optometrists and ophthalmologists.”

Ocuphire noted that the global prevalence of presbyopia is estimated at 2 billion.

An estimated 120 million Americans live with presbyopia, a high prevalence expected to exceed 150 million by 2034. There is currently no approved drug treatment for presbyopia.

Also, when it comes to payment, presbyopia correcting devices have generally been paid for in cash by patients..

Marguerite McDonald, MD, FACS, clinical professor of ophthalmology at NYU Langone Medical Center and member of the Ocuphire Medical Advisory Board, pointed out that presbyopia is a condition that affects almost everyone over the age of 40.

“Many patients who depend on reading glasses and contact lenses want more flexibility and convenience and continually ask for alternatives or a complementary choice,” she said in a statement. “The development of eye drop treatments for presbyopia has recently become very active, led by Allergan who recently submitted an NDA for this indication.”

McDonald noted that there was room for many options given the great unmet need, and she said she was encouraged by Nyxol eye drops in combination with low-dose pilocarpine eye drops as a. as a differentiated solution that works on both the iris dilator and the sphincter muscles.

“This combined product is expected to provide moderate unopposed pupillary constriction and provide the ability to see both near and far without the side effects such as sore eyebrows, headaches, blurred vision and associated loss of remote night vision. to the use of doses of pilocarpine, ”she said.

According to a GlobalData market research report, 69% of patients would consider eye drops as an alternative to reading glasses.

More than 70% of patients reported wearing reading glasses in the morning, afternoon and evening, suggesting that patients want a lasting solution.

Over 50% of respondents also indicated that using drops 2-4 times a day would be moderately to very convenient for them.

Additionally, 66% of eye care providers surveyed indicated interest in a low dose Nyxol and pilocarpine product profile as a potential therapeutic alternative to reading glasses.

VEGA-1 phase 2 clinical trial
The VEGA-1 clinical trial is designed to evaluate the efficacy and safety of Nyxol in combination with low dose pilocarpine compared to placebo in presbyopic subjects. A total of 150 subjects were recruited from 17 research sites in the United States between mid-February and mid-May of this year.

The phase 2 trial is randomized, double-masked, and placebo-controlled with 4 treatment arms.

On the first visit, subjects are randomized to receive Nyxol or placebo drops which are instilled at home near bedtime for 3-4 days before visit 2; in visit 2, subjects then receive either low dose pilocarpine or no treatment with efficacy and safety measures collected at multiple times for 6 hours.

Primary endpoint is the percentage of subjects with ≥ 15 letters of improvement in photopic binocular near vision (i.e., distance corrected near visual acuity, DCNVA) at 1 hour at the visit 2 for the Nyxol + low-dose pilocarpine arm compared to the placebo arm alone.

Secondary endpoints at multiple time points include improvements of 3 lines of DCNVA without loss of distance vision, pupil diameter, and improvements of 1 and 2 line DCNVA compared to placebo as well as each Nyxol and low dose pilocarpine alone.

The first results are expected by the end of the second quarter of 2021.

Ocuphire worked closely with Oculos Development Services, a Tampa, Florida-based clinical research organization and a subsidiary of Iuvo BioScience, on the initiation and execution of the VEGA-1 trial.

“We are delighted with the rapid enrollment of this Phase 2 trial, which demonstrates the unmet need for eye drops for the benefit of vision correction for patients with presbyopia,” Chuck Slonim, MD, Chief Physician and Monitor Oculos Development Services medical, said in a statement. “We thank our investigators, clinical coordinators, staff and subjects for their support and the ease of running the trials at 17 sites across the United States.”

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