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Original New Drug Application Approvals by US FDA (16 - 31 January 2022)

08 Feb 2022

New drug applications approved by US FDA as of 16-31 January 2022 which includes New Molecular Entities (NMEs) and new biologics. It does not include Tentative Approvals. Supplemental approvals may have occurred since the original approval date.

Original New Drug Application Approvals by US FDA (16 - 31 January 2022)

08 Feb 2022

RhNGF eye drops safe but does not confer significant neuroenhancement in glaucoma

05 Feb 2022

Treatment with topical recombinant human nerve growth factor (rhNGF) is safe and well tolerated but falls short of providing neuroprotection in patients with glaucoma, according to the results of a phase Ib study.

RhNGF eye drops safe but does not confer significant neuroenhancement in glaucoma

05 Feb 2022

Mindfulness meditation benefits extend to ocular hypertension

04 Feb 2022

Patients with ocular hypertension appear to fare well with mindfulness-based stress reduction (MBSR), which a recent study has shown to result in reductions in intraocular pressure (IOP) and cortisol levels, as well as improvements in optic nerve head perfusion and quality of life.

Mindfulness meditation benefits extend to ocular hypertension

04 Feb 2022

Brolucizumab shows favourable benefit–risk profile in diabetic macular oedema

01 Feb 2022

At a dose of 6 mg, brolucizumab yields substantial visual gains and anatomical improvements in patients with diabetic macular oedema without increasing the risk of serious adverse ocular events when compared with aflibercept, according to data from two phase III trials.

Brolucizumab shows favourable benefit–risk profile in diabetic macular oedema

01 Feb 2022

Concomitant microbial and herpes simplex keratitis has poor ocular, visual outcomes

30 Jan 2022

Ocular morbidity and visual outcomes are poor in patients with clinical presumed concomitant microbial and herpes simplex keratitis, a recent study has found.

Concomitant microbial and herpes simplex keratitis has poor ocular, visual outcomes

30 Jan 2022

Aflibercept delivers for diabetic macular oedema in real-world study

29 Jan 2022

Real-world data show that aflibercept effectively improves visual acuity (VA) outcomes in patients with diabetic macular oedema. However, factors such as age, baseline VA, and deprivation may affect the effectivity of aflibercept.

Aflibercept delivers for diabetic macular oedema in real-world study

29 Jan 2022

Streptococcus dominates post-traumatic endophthalmitis in kids

29 Jan 2022

Post-traumatic endophthalmitis in children is most commonly caused by Streptococcus pneumoniae, though the dominant species tends to vary greatly between age groups, a recent study has found. Visual outcomes in infected children remain poor even despite prompt treatment.

Streptococcus dominates post-traumatic endophthalmitis in kids

29 Jan 2022

Iridotomy an effective prophylactic in PACS, but risk of glaucoma progression low

28 Jan 2022 by

Undergoing prophylactic laser peripheral iridotomy (LPI) for primary angle-closure suspect (PACS) can reduce the risk of progression, although the likelihood of developing glaucoma without treatment is low overall, as shown in a Singapore study.

Iridotomy an effective prophylactic in PACS, but risk of glaucoma progression low

28 Jan 2022

OCT allows noninvasive assessment of pulsatile intracranial pressure

26 Jan 2022 by

Optical coherence tomography (OCT) can be used for the noninvasive measurement of pulsatile intracranial pressure, especially when using the OCT parameters peripapillary Bruch’s membrane angle and optic nerve head height, according to a recent study.

OCT allows noninvasive assessment of pulsatile intracranial pressure

26 Jan 2022

Eye-preserving therapies may do more harm than good in advanced retinoblastoma

21 Jan 2022

In the treatment of advanced retinoblastoma patients with bilateral disease, initial use of eye-preserving therapies appears to be associated with a worse overall survival, especially for those with very large tumours, according to a study.

Eye-preserving therapies may do more harm than good in advanced retinoblastoma

21 Jan 2022

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Original New Drug Application Approvals by US FDA (16 - 31 January 2022)

Original New Drug Application Approvals by US FDA (16 - 31 January 2022)

RhNGF eye drops safe but does not confer significant neuroenhancement in glaucoma

RhNGF eye drops safe but does not confer significant neuroenhancement in glaucoma

Mindfulness meditation benefits extend to ocular hypertension

Mindfulness meditation benefits extend to ocular hypertension

Brolucizumab shows favourable benefit–risk profile in diabetic macular oedema

Brolucizumab shows favourable benefit–risk profile in diabetic macular oedema

Concomitant microbial and herpes simplex keratitis has poor ocular, visual outcomes

Concomitant microbial and herpes simplex keratitis has poor ocular, visual outcomes

Aflibercept delivers for diabetic macular oedema in real-world study

Aflibercept delivers for diabetic macular oedema in real-world study

Streptococcus dominates post-traumatic endophthalmitis in kids

Streptococcus dominates post-traumatic endophthalmitis in kids

Iridotomy an effective prophylactic in PACS, but risk of glaucoma progression low

Iridotomy an effective prophylactic in PACS, but risk of glaucoma progression low

OCT allows noninvasive assessment of pulsatile intracranial pressure

OCT allows noninvasive assessment of pulsatile intracranial pressure

Eye-preserving therapies may do more harm than good in advanced retinoblastoma

Eye-preserving therapies may do more harm than good in advanced retinoblastoma